This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms (AAA) (NCT00695253), a na na study. The primary outcome is Number of Participants With Successful Exclusion of Abdominal Aortic Aneurysm.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00695253 |
| Phase | NA |
| Condition | Abdominal Aortic Aneurysms |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 49 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Rodney A. White, M.D. |
| Results posted | Yes |
2. Clinical Question
Population
Patients with abdominal aortic aneurysms who met the study’s inclusion and exclusion criteria. The registry record does not describe those criteria or provide a fuller account of participant characteristics.
Intervention
Treatment with the Talent Endoluminal Spring Graft System, an investigational device. The study describes this as an endoluminal treatment.
Comparator
There was no separate comparator group. The study is recorded as single-group, and allocation is listed as NA; it therefore does not provide a like-for-like control comparison.
Primary question
How many participants had successful exclusion of the abdominal aortic aneurysm after treatment, assessed from the treatment date through follow-up up to 5 years?
The study’s stated purpose was to evaluate the safety and effectiveness of the device in patients with abdominal aortic aneurysms. Its primary outcome was a count of participants whose aneurysm was successfully excluded. The registry record also names successful device delivery and deployment as a secondary outcome. Those are distinct questions: successful delivery and deployment concern whether the device was placed as intended, whereas aneurysm exclusion concerns the stated clinical result of treatment. Neither outcome, by itself, supplies a comparison with another treatment or with no treatment.
The treatment population is described as patients meeting inclusion and exclusion criteria, but the criteria themselves and the characteristics of enrolled participants are not reported in the registry record. The record gives an enrollment of 49. It does not report the number who contributed to each outcome, whether all participants completed follow-up, or the result for the primary outcome. Consequently, the record defines the clinical question but does not give enough outcome information to judge how often successful exclusion was recorded.
Follow-up was planned at one, six, and 12 months, then annually through five years after the procedure. The primary outcome timeframe is described as extending from treatment to assessment up to 5 years post-treatment. The record does not explain how assessments at different follow-up times were combined into the participant count.
3. Trial Design
The registry describes a completed, single-group study of the Talent Endoluminal Spring Graft System in patients with abdominal aortic aneurysms. Enrollment was 49. The intervention is classified as a device, and the study description identifies the endoluminal graft system as the treatment under evaluation. The study’s sponsor is Rodney A. White, M.D.
Allocation is listed as NA, masking as NONE, and the model as SINGLE GROUP. There is no separate control arm in the registry description. The study therefore records outcomes among treated participants rather than estimating a randomized contrast between treatment groups. The registry cautions that the arms are not a like-for-like control comparison; in this single-group record, no control group is described.
The study began in 2002-04, and primary completion is recorded as 2013-03. Its status is COMPLETED. The phase is listed as NA. The registry record does not report a protocol rationale for the design, a sample-size justification, or additional details about how participants were recruited or treated. Such information should not be inferred from the enrollment or the follow-up schedule.
The planned follow-up evaluations were at one, six, and 12 months after the procedure and annually thereafter up to five years. The primary outcome is framed as the number of participants with successful exclusion of the aneurysm, with assessment from treatment through follow-up up to 5 years. A secondary outcome is the number of participants with successful device delivery and deployment. The record lists two outcome measures but reports no analyses.
In general, a single-group design can describe what was observed among people receiving an intervention, but it cannot separate an intervention’s effect from other explanations using a concurrent control comparison. Changes over time, participant selection, and other factors may affect interpretation. Because no comparative estimate or primary-outcome result is reported, the registry entry does not establish how the observed outcomes compare with an alternative approach.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Talent Endoluminal Spring Graft System |
|---|---|
| STARTED | 49 |
| COMPLETED | 18 |
| NOT COMPLETED | 31 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | There Are no Study Arms. |
|---|---|---|
| Participants analysed | 49 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 5 |
| Age, Categorical: >=65 years | Participants | 44 |
| Age, Continuous | years | 74.64 (SD 3.78) |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 48 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 48 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 |
| Race (NIH/OMB): Black or African American | Participants | 5 |
| Race (NIH/OMB): White | Participants | 42 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 49 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Successful Exclusion of Abdominal Aortic Aneurysm, measured over From the date of treatment assessed up to 5 years post treatment..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants' AAA |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of participants with successful exclusion of an abdominal aortic aneurysm after treatment with the Talent Endoluminal Spring Graft System. The registry describes the endpoint as a measure used to determine the device’s safety and effectiveness, and gives a timeframe from the treatment date to assessment up to 5 years post-treatment.
This endpoint focuses on whether the aneurysm was recorded as excluded following the endoluminal procedure. A count is a straightforward way to describe how many participants met a specified outcome definition. It does not, on its own, indicate the proportion of all treated participants who met the definition, because the record does not provide the outcome count or state the denominator used for that assessment. The endpoint definition also does not specify the clinical criteria used to classify successful exclusion, and those criteria are not reported in the registry record.
As a general statistical point, an endpoint needs a clear definition, assessment schedule, and rule for handling participants whose status cannot be determined. Those details help readers understand what a reported count represents and how comparable assessments are across participants. The registry gives the broad outcome and timeframe, but does not report the detailed assessment rules or how observations across follow-up were handled.
The secondary outcome concerns successful device delivery and deployment. That outcome addresses procedural delivery rather than the primary endpoint’s aneurysm-exclusion status. The registry record does not report a result for either outcome, so the stated endpoint definitions should not be mistaken for evidence that the outcomes were achieved.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a completed study with enrollment of 49, but it does not report the primary endpoint result. In particular, it gives no count of participants with successful exclusion of the abdominal aortic aneurysm. The result for successful device delivery and deployment, the listed secondary outcome, is also not reported in the registry record. These omissions prevent a quantitative interpretation of either efficacy-related outcome from this entry.
The design is single-group, with allocation listed as NA and masking listed as NONE. No comparator group is described. As a result, the record cannot provide a randomized estimate of the difference between the device and another treatment or control. Even if an outcome count were available, a treated-group count alone would describe observed experience, not establish what would have happened to the same participants under a different approach.
The safety information lists 29 participants affected by serious adverse events among 49 at risk, 4 affected by other adverse events among 49 at risk, and 19 deaths. These are registry counts, not a comparative safety estimate. The record does not report whether the adverse events or deaths were considered related to the device, when they occurred, or how event categories overlap. The serious-event terms listed include Endoleak, Lung Cancer, Stent Graft occlusion, Myocardial infarction, Congestive Heart Failure, and Stent Graft migration, each with its posted percentage. Their clinical context and attribution are not reported in the registry record.
In general, a count requires context to support interpretation: the outcome definition, the number assessed, the timing of assessment, and the handling of participants with missing information. For a longitudinal outcome, the method used to combine assessments over time is also important. Those details are not reported for the primary endpoint. The planned follow-up extended from early post-procedure assessments through annual follow-up up to five years, but the record does not say how many participants were assessed at each time.
The registry reports no analyses. It does not provide an effect estimate, confidence interval, hypothesis test, or statistical model for the primary endpoint. No precision estimate can therefore be interpreted from the record. As a general statistical point, a confidence interval describes the range of values compatible with an estimate under the method’s assumptions; without a reported estimate and interval, readers cannot assess the precision of the outcome estimate.
The entries should be read as a description of the study design, outcome definitions, and posted safety counts, rather than as a complete account of clinical results. The reported enrollment does not establish the number with evaluable outcome data. The completed status likewise does not supply missing outcome estimates. The record supports neither a claim that the device succeeded nor a claim that it failed; the primary result is not reported in the registry record.
9. Statistical Methods Explained
What does the single-group design estimate?
The registry identifies the study as SINGLE GROUP. It records the experience of participants treated with the Talent Endoluminal Spring Graft System, without describing a separate comparator group. The primary outcome is a count of participants with successful aneurysm exclusion. This structure can describe outcomes in the treated group if the results and assessment details are reported, but it does not estimate a treatment contrast against another group.
As a general statistical point, a controlled comparison helps distinguish differences associated with treatment assignment from differences that might arise through participant characteristics, clinical course, or other influences. A single-group observation has no concurrent control estimate to make that distinction. The registry record does not report a comparative analysis or any method intended to address this limitation.
What does a count endpoint tell the reader?
The primary outcome is expressed as the number of participants meeting the successful-exclusion definition. Counts are readily interpretable as tallies, but their meaning depends on the denominator and the rule for determining success. The registry lists enrollment of 49, yet does not report the primary outcome count, the number assessed, or an analysis population. It is therefore not possible to tell how many of the enrolled participants contributed an outcome assessment or how the endpoint was summarized.
As a general statistical point, a count can be accompanied by a proportion or an uncertainty interval when an appropriate denominator and analysis method are specified. Those are not reported for this endpoint, and no new estimate can be recovered from the registry description alone. The record also does not state whether a participant had to meet the success definition at a particular visit or at any point during follow-up.
How does the follow-up schedule affect interpretation?
The study description specifies evaluations at one, six, and 12 months, with annual assessments thereafter up to five years. The primary endpoint timeframe is described as extending from treatment through assessment up to 5 years post-treatment. These details indicate that observation was planned over time, but the record does not provide the results at individual visits or say how multiple assessments were reduced to the stated participant count.
In general, longitudinal follow-up can reveal whether an outcome is present at particular time points or changes over time. The appropriate summary depends on the clinical question and on how observations are collected. A single cumulative count, a visit-specific count, and a time-to-event analysis answer different questions. The registry lists no analyses, and it does not report a time-to-event result or a rule for handling changes in outcome status.
What can be learned from the listed safety counts?
The safety record lists 29 participants affected by serious adverse events among 49 at risk, 4 affected by other adverse events among 49 at risk, and 19 deaths. It also provides percentages for selected serious-event terms. These are descriptive safety entries. The record does not provide a comparison group, event timing, exposure-adjusted analysis, or attribution to the device.
As a general statistical point, adverse-event counts and participant counts are not necessarily interchangeable: one participant may experience more than one event, and categories may overlap. The registry labels counts of affected participants, but does not provide detail about repeated events or overlap among the listed categories. The percentages attached to selected terms should be read as posted, without assuming a denominator or a causal relationship that the record does not specify.
Why do precision and model assumptions matter?
No primary-outcome estimate, interval, test, or model is reported. Accordingly, there is no statistical precision estimate to interpret. In general, a confidence interval expresses uncertainty around an estimate under a stated method and its assumptions. It does not remove design limitations, and it cannot be interpreted without knowing what quantity was estimated and how the analysis was conducted.
For count outcomes, a statistical model may be considered when making inferences beyond a simple tally. General methods need assumptions about the outcome distribution and the relationship between observations. Over-dispersion, in general, means that variability exceeds what a chosen model expects; ignoring it can make uncertainty estimates too small. There is no indication in the registry record that such a model was used, and no model or dispersion assessment is reported. These concepts explain why analysis details matter; they do not describe analyses known to have been conducted in this study.
The record includes sample-size assumptions for a planning illustration computed from an observed effect, including a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. However, no observed effect or analysis supporting such an illustration is reported in the registry entry. Those planning assumptions do not document the trial’s original design rationale, do not constitute observed power, and do not substitute for a reported primary result. The trial’s own sample-size justification is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures: the primary outcome of successful exclusion of the abdominal aortic aneurysm and the secondary outcome of successful device delivery and deployment. It reports no analyses. A statistical plan for prioritizing outcomes, controlling multiplicity, or interpreting multiple tests is not reported in the registry record. No multiplicity adjustment or hierarchy of statistical hypotheses can be inferred from the outcome labels alone.
As a general statistical point, evaluating multiple outcomes or repeated statistical tests can increase the chance of a nominally notable result arising by chance when each test is interpreted independently. A prespecified analysis plan can clarify which outcome is primary, how secondary outcomes are treated, and whether adjustments are used. Here, the record identifies primary and secondary outcomes but does not report inferential results or a multiplicity strategy.
Missing-data methods and analysis populations are also not reported in the registry record. Enrollment is 49, but the record does not state how many participants completed each follow-up assessment, how participants with unknown outcome status were handled, or whether all enrolled participants were included in each outcome summary. It does not report whether analyses used an intention-to-treat, per-protocol, or other defined population. No assumption about missing outcomes should therefore be made.
In general, missing follow-up can affect interpretation when participants with observed outcomes differ from those without them. The extent and direction of any effect depend on the missingness pattern and the analysis approach. Since neither the pattern nor the approach is described, the potential influence of missing data cannot be evaluated from this registry entry.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Talent Endoluminal Spring Stent Graft System | 29 | 49 | 59.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Talent Endoluminal Spring Stent Graft System | 19 of 49 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Talent Endoluminal Spring Stent Graft System | 4 of 49 |
Most frequent serious adverse event terms
| Event term | Organ system | Talent Endoluminal Spring Stent Graft System |
|---|---|---|
| Endoleak | Vascular disorders | 9 of 49 |
| Lung Cancer | Respiratory, thoracic and mediastinal disorders | 6 of 49 |
| Stent Graft occlusion | Vascular disorders | 3 of 49 |
| Myocardial infarction | Cardiac disorders | 2 of 49 |
| Congestive Heart Failure | Cardiac disorders | 2 of 49 |
| Stent Graft migration | Vascular disorders | 2 of 49 |
| Vessel Injury | Vascular disorders | 1 of 49 |
| Ruptured AAA | Vascular disorders | 1 of 49 |
| Ruptured TAA | Vascular disorders | 1 of 49 |
| Renal Cancer | Renal and urinary disorders | 1 of 49 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Talent Endoluminal Spring Stent Graft System |
|---|---|---|
| Hypertension | Vascular disorders | 2 of 49 |
| Peripheral Vascular Disease | Vascular disorders | 2 of 49 |
Serious events with the highest arm-level rate: endoleak (18.4%), lung cancer (12.2%), stent graft occlusion (6.1%), myocardial infarction (4.1%), congestive heart failure (4.1%).
The registry lists 29 participants affected by serious adverse events among 49 at risk, 4 participants affected by other adverse events among 49 at risk, and 19 deaths in the Talent Endoluminal Spring Stent Graft System group. These entries are descriptive counts. They do not establish whether an event was caused by the device or procedure, and the registry record does not report attribution, timing, or the circumstances of the deaths.
The serious-event terms with posted percentages are Endoleak at 18.4%, Lung Cancer at 12.2%, Stent Graft occlusion at 6.1%, Myocardial infarction at 4.1%, Congestive Heart Failure at 4.1%, and Stent Graft migration at 4.1%. The record does not provide further details about how these percentages were calculated, whether a participant could appear under more than one term, or whether the terms represent all serious events recorded.
As a general statistical point, adverse-event summaries need careful interpretation because a participant may experience multiple events, events can differ in severity and timing, and observed counts do not by themselves show causation. A control group and consistent follow-up can help contextualize safety comparisons, but no comparator is described in this study. The posted counts therefore describe reported safety experience without establishing comparative risk.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed, single-group study evaluated the Talent Endoluminal Spring Graft System in patients with abdominal aortic aneurysms, with enrollment of 49. It states that the primary outcome was the number of participants with successful aneurysm exclusion and identifies successful device delivery and deployment as a secondary outcome. It also records safety counts and a planned follow-up schedule extending up to five years.
Those design and outcome details do not supply the missing clinical results. The primary endpoint count and the secondary-outcome result are not reported in the registry record. No effect estimate, confidence interval, hypothesis test, or analysis is reported. The completed status cannot be treated as a result, and the enrollment number cannot be treated as the number with complete follow-up.
The safety counts describe events recorded in the registry, but do not explain event attribution or timing and do not provide a comparison with another treatment. In general, observed events in a single group can describe what was recorded among participants, but cannot by themselves determine how many events would have occurred under a different approach.
The result does not establish that the device is effective or ineffective, nor does it establish that listed events were caused by the device. Those conclusions would require outcome findings and context that are not reported in the registry record, as well as an appropriate design and analysis for the question being asked. The appropriate reading is limited: the registry describes the study’s intent, design, endpoint definitions, follow-up plan, and posted safety figures, while leaving the primary clinical outcome unreported.
As a general statistical principle, absence of a reported estimate is not evidence that an effect is absent or present. It means that the effect and its precision cannot be evaluated from this record. Readers should distinguish the stated purpose of the study from results actually reported.
13. Why This Trial Matters Statistically
This study is statistically notable because its registry record makes the distinction between a stated research question and a reported result especially important. The study set out to evaluate safety and effectiveness, and it identifies a primary endpoint based on successful aneurysm exclusion. Yet the registry record does not report the endpoint count or any analysis. A clearly named endpoint is useful, but the definition alone cannot answer the research question.
The single-group design also defines what kinds of conclusions are possible. In general, a treated-group description can characterize observed outcomes, while a comparative design is needed to estimate differences between treatment strategies with a concurrent reference. The study has no separate comparator described, so its design cannot produce a randomized comparative effect estimate.
The record also illustrates why follow-up and analysis details matter. Evaluations were planned at one, six, and 12 months and annually thereafter up to five years. Without visit-level results, outcome assessment rules, and information about missing follow-up, readers cannot tell how the longitudinal data informed the primary count. The lack of reported statistical analyses further limits assessment of precision and robustness.
Safety counts are meaningful descriptive information, but their interpretation depends on details such as timing, attribution, and overlap among events. Those details are not reported. Taken together, the record shows how design, endpoint definition, follow-up, and transparent results reporting each contribute to statistical interpretation. It also shows the limits of drawing conclusions when the outcome definitions are present but the outcome results are not.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
This registry record provides limited information for evaluating the primary clinical outcome. It defines successful exclusion as the primary endpoint but does not report the number of participants achieving it, the number assessed, or the criteria used to classify success. The result for the secondary outcome of successful device delivery and deployment is also not reported.
The study is single-group, with no comparator described. This limits interpretation to the design’s capacity to characterize treated participants and precludes a like-for-like control comparison. Masking is listed as NONE. The registry record does not report whether outcome assessment was performed independently or describe other procedures intended to reduce assessment bias.
Although follow-up evaluations were planned at one, six, and 12 months and annually thereafter up to five years, the record does not give follow-up completion, visit-specific results, or the method used to summarize outcomes over time. Missing-data handling, analysis populations, statistical methods, and multiplicity procedures are not reported. The record also does not report a sample-size justification or detailed eligibility criteria.
The safety entries lack information about event timing, relationship to the device or procedure, and overlap between categories. The listed deaths are not contextualized by cause or timing in the registry record. These gaps prevent a fuller assessment of safety patterns and their relation to treatment.
Finally, the registry lists no analyses. There is no reported primary estimate or measure of its precision. The study’s completed status and enrollment should not be mistaken for evidence that the outcome was achieved or that all participants contributed complete data.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms (AAA) — NCT00695253.
- Registry record last updated 2023-02-15; status last verified 2023-02.
- Results first posted 2021-09-29.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT00695253 is a completed, single-group study of the Talent Endoluminal Spring Graft System in patients with abdominal aortic aneurysms. Enrollment was 49. The study began in 2002-04, and primary completion is recorded as 2013-03. Allocation is listed as NA and masking as NONE.
The primary outcome was the number of participants with successful exclusion of the aneurysm, assessed from treatment through follow-up up to 5 years. Successful device delivery and deployment was listed as a secondary outcome. The record reports no analyses and does not report results for either outcome.
Safety entries list 29 participants affected by serious adverse events among 49 at risk, 4 affected by other adverse events among 49 at risk, and 19 deaths. Event attribution and timing are not reported. The study design and posted safety counts can be described, but the primary clinical result and its statistical precision cannot be evaluated from the registry record.