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 ILLUMENATE EU Randomized Clinical Trial (NCT01858363), a randomized na study. The primary outcome is Patency at 12-months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01858363 |
| Phase | NA |
| Condition | Peripheral Arterial Disease, Claudication |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 294 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Spectranetics Corporation |
| Results posted | Yes |
2. Clinical Question
Population
The trial enrolled subjects with peripheral arterial disease and claudication who had de novo occluded or stenotic lesions, or re-occluded or restenotic lesions, in the superficial femoral or popliteal arteries. The primary endpoint was analyzed at the lesion level rather than the participant level. The registry record does not report further eligibility details in the endpoint description.
Intervention
The intervention was a CVI paclitaxel-coated percutaneous transluminal angioplasty balloon catheter. The registry describes the trial as prospective, randomized, multi-center, and single-blinded. It does not report further details about the blinding procedure in the record.
Comparator
The comparator was a bare percutaneous transluminal angioplasty balloon catheter. Both arms are described as including subjects with the lesion types specified for the trial. The treatment assignment was randomized between the paclitaxel-coated balloon and the bare balloon.
Primary question
The primary question was whether lesions treated with the paclitaxel-coated balloon were patent at 12 months, using the trial definition of patency, compared with lesions treated with a bare balloon. Patency required both absence of target lesion restenosis by duplex ultrasound peak systolic velocity ratio ≤2.5 and freedom from clinically-driven target lesion revascularization. The registry reports percentages and 95% confidence intervals for each arm, but no direct comparison analysis is posted.
3. Trial Design
ILLUMENATE EU was a prospective, randomized, multi-center, single-blinded, parallel-group clinical trial. Its registry status is completed, and its listed enrollment is 294. The listed phase is not applicable. The registry gives a start date of 2012-11 and a primary completion date of 2016-03; these dates describe the record and do not establish the follow-up duration for every participant.
The two treatment groups received either a CVI paclitaxel-coated percutaneous transluminal angioplasty balloon catheter or a bare percutaneous transluminal angioplasty balloon catheter. The trial concerned de novo occluded or stenotic lesions and re-occluded or restenotic lesions of the superficial femoral and popliteal arteries. The registry describes random allocation and single masking, but details of how the masking was maintained are not reported in the registry record.
The primary outcome was patency at 12 months after the procedure. The record defines the analysis population by lesions, not by participants. In the paclitaxel-coated arm, 222 subjects represented 254 lesions, of which 224 were evaluable. In the bare-balloon arm, 72 subjects represented 79 lesions. The registry’s endpoint population description ends before stating how many of those lesions were evaluable, so that information is not reported in the registry record.
The two arm estimates are 83.9% and 60.6%, respectively, with 95% confidence intervals of 78.5% to 88.5% and 47.8% to 72.4%. These are arm-specific estimates, not a posted estimate of the difference between treatment groups. No direct analysis entry is reported in the registry record.
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 | Paclitaxel-coated Balloon | Bare Balloon |
|---|---|---|
| STARTED | 222 | 72 |
| Pre-discharge Visit | 219 | 72 |
| 1-month Visit | 214 | 68 |
| 6-month Visit | 208 | 64 |
| 12-month Vist | 205 | 61 |
| 24-month Visit | 184 | 58 |
| 36-month Visit | 169 | 53 |
| 48-month Visit | 157 | 53 |
| COMPLETED | 146 | 46 |
| NOT COMPLETED | 76 | 26 |
Reasons for not completing this period:
| Reason | Paclitaxel-coated Balloon | Bare Balloon |
|---|---|---|
| Death | 35 | 9 |
| Withdrawal by Subject | 28 | 14 |
| Lost to Follow-up | 13 | 3 |
Analysis population for the primary outcome, as defined in the registry: The analysis for the primary patency was based on the lesion success and not participant success. In the Paclitaxel-coated balloon arm, 222 subjects represents 254 lesions. Of those 254 lesions, only 224 lesions were evaluable. In the Bare balloon arm, 72 subjects represents 79 lesions. Of those 79 lesions, only 66 lesions were evaluable.
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.
Population: The Baseline Participants are based on the Intent-to-Treat (ITT) analysis set. The safety data for the adverse events section will be based on the Safety Set which has 219 participants in the Paclitaxel-coated arm and 68 in the Bare balloon arm.
| Characteristic | Unit | Paclitaxel-coated Balloon | Bare Balloon | Total |
|---|---|---|---|---|
| Participants analysed | 222 | 72 | 294 | |
| Age, Continuous | years | 66.8 (SD 9.2) | 69.0 (SD 8.6) | 67.3 (SD 9.1) |
| Sex: Female, Male: Female | Participants | 62 | 23 | 85 |
| Sex: Female, Male: Male | Participants | 160 | 49 | 209 |
| Rutherford Clinical Category: Rutherford Clinical Category 2 | Participants | 34 | 15 | 49 |
| Rutherford Clinical Category: Rutherford Clinical Category 3 | Participants | 183 | 55 | 238 |
| Rutherford Clinical Category: Rutherford Clinical Category 4 | Participants | 4 | 1 | 5 |
| Diabetes | Participants | 83 | 26 | 109 |
| Hypertension | Participants | 173 | 60 | 233 |
| Hyperlipidemia | Participants | 137 | 49 | 186 |
| Smoking status: Never Smoked | Participants | 24 | 12 | 36 |
| Smoking status: Previous or current | Participants | 198 | 60 | 258 |
| Baseline Ankle Brachial Index | ratio | 0.72 (SD 0.21) | 0.69 (SD 0.26) | 0.71 (SD 0.22) |
| Lesion length (mm) | mm | 71.8 (SD 51.9) | 70.8 (SD 52.7) | 71.6 (SD 52.0) |
| Lesion type: De novo | lesions | 234 | 71 | 305 |
| Lesion type: Restonotic | lesions | 20 | 8 | 28 |
| Total Occlusion | lesions | 48 | 15 | 63 |
| Calcification: None/Mild | lesions | 140 | 47 | 187 |
| Calcification: Moderate | lesions | 79 | 24 | 103 |
| Calcification: Severe | lesions | 32 | 8 | 40 |
| Diameter stenosis | % Diameter Stenosis | 78.7 (SD 16.0) | 80.8 (SD 15.7) | 79.2 (SD 15.9) |
| Reference vessel Diameter | mm | 5.02 (SD 0.79) | 4.77 (SD 0.69) | 4.96 (SD 0.78) |
6. Primary Endpoint
The registry lists the primary outcome as Patency at 12-months, measured over 12 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of lesions |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint, patency at 12 months, describes whether a treated lesion remained free of target lesion restenosis and clinically-driven target lesion revascularization after the procedure. Restenosis was defined using duplex ultrasound: peak systolic velocity ratio ≤2.5 was required for the lesion to meet the stated patency definition. The endpoint therefore combines an imaging-based criterion with freedom from a clinically driven repeat intervention.
Patency is useful as an endpoint because it expresses a treatment outcome at the site being treated, using criteria stated in advance in the registry description. The reported unit is the percentage of lesions, and the record explicitly says that the primary analysis was based on lesion success rather than participant success. A participant could contribute more than one lesion: the paclitaxel-coated arm included 222 subjects representing 254 lesions, and the bare-balloon arm included 72 subjects representing 79 lesions.
The reported values are 83.9% for the paclitaxel-coated balloon and 60.6% for the bare balloon. Their 95% confidence intervals are 78.5% to 88.5% and 47.8% to 72.4%. In general, a confidence interval communicates uncertainty around an estimated quantity under the method used to calculate it. The method used for these intervals is not reported in the registry record. The endpoint estimates alone do not give a formal statistical test of the difference between arms.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
At 12 months, the registry reports patency of 83.9% in the paclitaxel-coated balloon arm and 60.6% in the bare-balloon arm. The corresponding 95% confidence intervals are 78.5% to 88.5% and 47.8% to 72.4%. The registry defines the endpoint at the lesion level, so these percentages should be understood as lesion-level results rather than the proportion of participants with a successful outcome.
The confidence intervals describe uncertainty around each arm’s estimate; they are not confidence intervals for the difference between arms. Their ranges do not overlap, but that visual feature does not replace a direct comparison analysis. The registry record does not post a p-value, confidence interval for a between-arm effect, adjusted analysis, or other direct test for the primary endpoint. The appropriate reading is therefore to describe the two reported arm estimates and their precision, not to claim a statistically established treatment contrast from the registry results alone.
The numbers of subjects and lesions are not interchangeable. The paclitaxel-coated arm includes 222 subjects representing 254 lesions, with 224 lesions evaluable. The bare-balloon arm includes 72 subjects representing 79 lesions, but the number of evaluable lesions for that arm is not reported in the registry record. Thus, readers should not treat the subject counts as the denominators for the lesion-level endpoint or infer the missing evaluable-lesion count.
The registry reports no posted analysis entries, and no secondary outcome results are posted. Consequently, there is no reported analysis explaining whether covariates, clustering of multiple lesions within a participant, or other features were included in an inferential comparison. The record also does not report the method used to calculate the confidence intervals. These omissions limit the statistical conclusions that can be drawn from the posted endpoint results.
The results describe outcomes among lesions evaluated at the stated time point, subject to the endpoint’s definition and the registry’s reporting. They do not by themselves establish why an outcome occurred, how the endpoint relates to other outcomes, or what a participant should choose. The posted evidence is descriptive by arm, with uncertainty intervals, rather than a complete report of a comparative statistical analysis.
9. Statistical Methods Explained
The registry presents an arm-level percentage for the primary endpoint, patency at 12 months, together with a 95% confidence interval for each arm. It classifies this endpoint as a count outcome that is not reduced to one comparison. No inferential analysis entries are posted. The registry therefore provides estimates by arm, but does not provide a direct statistical estimate of the treatment contrast.
What does a confidence interval describe?
In general, a confidence interval gives a range of values compatible with the observed estimate under the assumptions of its statistical method. It helps communicate precision: a narrower interval represents less uncertainty in the estimate than a wider interval, all else being equal. Here, the reported intervals are 78.5% to 88.5% for the paclitaxel-coated balloon and 47.8% to 72.4% for the bare balloon. The registry record does not identify the calculation method, so the assumptions behind those intervals cannot be evaluated from the posted information.
An interval for each arm is not the same as an interval for a difference between arms. A direct comparison would need to account for the treatment groups and the analysis unit, and would report an effect estimate and its uncertainty or a test result. Those results are not reported in the registry record. The two arm-specific estimates can be described as reported, but they should not be converted into a new difference, ratio, or p-value.
Why does the lesion-level unit matter?
The primary analysis was based on lesion success, not participant success. The paclitaxel-coated arm’s 222 subjects represented 254 lesions, of which 224 were evaluable. The bare-balloon arm’s 72 subjects represented 79 lesions; the number evaluable for the endpoint is not reported in the registry record. Since a participant may contribute more than one lesion, the lesion observations need not be independent. In general, statistical methods for clustered observations can account for dependence among observations from the same participant. Whether the trial’s analysis used such a method is not reported in the registry record.
The reported arm counts for subjects should not be substituted for lesion denominators. The endpoint is explicitly expressed as a percentage of lesions. The record does not describe the precise denominator used to calculate each arm’s percentage beyond the evaluability information for the paclitaxel-coated arm, nor does it fully state the evaluability information for the bare-balloon arm.
What can be said about the comparison?
The registry supplies two arm estimates and their confidence intervals, but lists no analysis entries. A comparison test or treatment-effect interval would answer a different question from the uncertainty around each arm separately. In general, a test addresses compatibility of the observed between-group contrast with a null hypothesis under a specified model; an interval for the contrast describes the range of plausible values under that model. Neither is posted for this endpoint. There is also no reported adjustment strategy, statistical model, or handling of multiple lesions per participant.
The registry labels the primary measure as a count outcome that is not reduced to one comparison. This makes the absence of a direct two-arm effect particularly important: the posted results should be read as separate arm summaries. The interval endpoints do not, on their own, provide the missing comparison analysis.
How should planning illustrations be read?
Planning illustrations based on the observed effect use the stated assumptions of a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. In general, such calculations describe hypothetical sample sizes for a specified planning scenario. They are not evidence that the trial had a given probability of detecting an effect, and they are not observed power. They also do not establish that the trial’s original design used those assumptions. The trial’s own sample-size justification is not reported in the registry record.
For this endpoint, sample-size interpretation also depends on the analysis unit and outcome definition. The endpoint is lesion-based, while the registry’s arm descriptions count subjects and lesions separately. A planning calculation based on independent observations may not reflect the implications of multiple lesions within participants unless that dependence is accounted for. The analysis details needed to assess that issue are not reported.
What is not specified?
The record does not report the method for calculating the confidence intervals, a direct comparison model, a p-value, a treatment-effect confidence interval, covariate adjustment, handling of clustering, or the endpoint’s full evaluability accounting in the bare-balloon arm. It also does not report an interim analysis plan or a sample-size justification. Without those details, the posted arm summaries support descriptive interpretation, but not reconstruction of a formal analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures, but no secondary outcome results are posted, and no analysis entries are listed. The primary outcome described in detail is patency at 12 months. The other outcome measure’s details and results are not reported in the registry record. A multiplicity strategy for managing inference across outcomes or analyses is also not reported in the registry record.
Missing outcome information affects interpretation of the primary result. For the paclitaxel-coated arm, 224 of 254 lesions were evaluable from among the 222 subjects. For the bare-balloon arm, 79 lesions are reported among 72 subjects, but the registry’s endpoint population description does not state how many were evaluable. The evaluable lesion count for that arm is not reported in the registry record. The reason for non-evaluability, any imputation, and any sensitivity analysis for missing outcomes are not reported in the registry record.
The analysis population is described as lesion-based rather than participant-based. The record does not specify whether all randomized lesions, treated lesions, or another defined set contributed to each percentage beyond the information on evaluability. Nor does it describe the handling of multiple lesions belonging to one participant. Those details matter when interpreting denominators and uncertainty because lesions from the same participant may be related; this is a general statistical consideration, not a reported feature of the analysis.
Randomization is reported, but the registry does not state how missing primary endpoint data were handled in the analysis or whether any sensitivity analyses were conducted. These omissions mean that the effect of missingness on the reported percentages cannot be assessed from the registry record.
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 |
|---|---|---|---|
| Paclitaxel-coated Balloon | 118 | 219 | 53.9% |
| Bare Balloon | 38 | 68 | 55.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Paclitaxel-coated Balloon | 35 of 219 |
| Bare Balloon | 9 of 68 |
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 |
|---|---|
| Paclitaxel-coated Balloon | 180 of 219 |
| Bare Balloon | 51 of 68 |
Most frequent serious adverse event terms
| Event term | Organ system | Paclitaxel-coated Balloon | Bare Balloon |
|---|---|---|---|
| FEMORAL ARTERY DISSECTION | Vascular disorders | 17 of 219 | 6 of 68 |
| PERIPHERAL ARTERY STENOSIS | Vascular disorders | 15 of 219 | 6 of 68 |
| PERIPHERAL ARTERY RESTENOSIS | Injury, poisoning and procedural complications | 6 of 219 | 12 of 68 |
| CORONARY ARTERY DISEASE | Cardiac disorders | 9 of 219 | 0 of 68 |
| CAROTID ARTERY STENOSIS | Nervous system disorders | 6 of 219 | 0 of 68 |
| FEMORAL ARTERY OCCLUSION | Vascular disorders | 5 of 219 | 1 of 68 |
| CATHETER SITE HAEMORRHAGE | General disorders | 5 of 219 | 0 of 68 |
| VASCULAR PSEUDOANEURYSM | Injury, poisoning and procedural complications | 3 of 219 | 2 of 68 |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | 5 of 219 | 0 of 68 |
| DEVICE OCCLUSION | General disorders | 4 of 219 | 0 of 68 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Paclitaxel-coated Balloon | Bare Balloon |
|---|---|---|---|
| PERIPHERAL ARTERY RESTENOSIS | Injury, poisoning and procedural complications | 20 of 219 | 15 of 68 |
| PERIPHERAL ARTERY STENOSIS | Vascular disorders | 21 of 219 | 9 of 68 |
| FEMORAL ARTERY DISSECTION | Vascular disorders | 21 of 219 | 7 of 68 |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | 14 of 219 | 5 of 68 |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | 14 of 219 | 4 of 68 |
| INTERMITTENT CLAUDICATION | Vascular disorders | 15 of 219 | 3 of 68 |
| CORONARY ARTERY DISEASE | Cardiac disorders | 10 of 219 | 0 of 68 |
| BACK PAIN | Musculoskeletal and connective tissue disorders | 10 of 219 | 0 of 68 |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | 7 of 219 | 2 of 68 |
| CAROTID ARTERY STENOSIS | Nervous system disorders | 8 of 219 | 1 of 68 |
Serious events with the highest arm-level rate: peripheral artery restenosis (17.6%), femoral artery dissection (8.8%), peripheral artery stenosis (8.8%), coronary artery disease (4.1%), pancreatitis chronic (2.9%).
The registry lists safety figures separately for the two arms. For the paclitaxel-coated balloon group, the serious-event figures are 118 affected among 219 at risk, and the other-event figures are 180 affected among 219 at risk; 35 deaths are listed. For the bare-balloon group, the serious-event figures are 38 affected among 68 at risk, and the other-event figures are 51 affected among 68 at risk; 9 deaths are listed. These counts should be read with their listed at-risk denominators and not confused with the primary endpoint’s lesion counts.
The listed serious-event terms and percentages include peripheral artery restenosis at 17.6%, femoral artery dissection at 8.8%, peripheral artery stenosis at 8.8%, coronary artery disease at 4.1%, pancreatitis chronic at 2.9%, and femur fracture at 2.9%. The registry record does not make clear in this listing whether each term is reported across both groups or by a particular group, so these percentages should not be assigned to an arm without further information.
In general, safety counts describe events recorded under the registry’s reporting definitions; they do not by themselves establish that a treatment caused an event. The record does not provide a comparative safety analysis, event timing, or further details of event attribution. The listed deaths are counts, not a reported comparison of mortality between arms.
12. What the Result Does, and Does Not, Mean
The posted primary results show lesion-level patency at 12 months of 83.9% for the paclitaxel-coated balloon arm and 60.6% for the bare-balloon arm. Their 95% confidence intervals are 78.5% to 88.5% and 47.8% to 72.4%, respectively. These values describe the reported outcomes in each arm and the uncertainty intervals attached to those estimates.
The estimates do not, by themselves, establish the size or statistical certainty of a treatment effect. The registry record does not post a formal comparison, a p-value, or a confidence interval for a between-arm contrast. Even though the arm-specific interval ranges do not overlap, that observation is not a substitute for a prespecified comparison method and should not be presented as a reported test result.
The outcome is defined at the lesion level, not at the participant level. The reported subject counts therefore do not directly give the denominators for the endpoint. In particular, the registry reports 224 evaluable lesions among 254 lesions in the paclitaxel-coated arm, while the evaluable lesion count for the bare-balloon arm is not reported in the registry record. This limits assessment of the two estimates’ denominators and of how missing endpoint data may have affected them.
The results also do not explain the statistical method used for the confidence intervals, the handling of multiple lesions from one participant, or any adjustment for other variables. The registry does not report secondary outcome results or an analysis addressing those questions. Consequently, readers can describe the arm-specific 12-month patency estimates as posted, while recognizing that the record lacks key details needed to reconstruct or fully evaluate the comparative analysis.
More broadly, a registry result is a report of measured outcomes under the definitions and follow-up described. It does not alone establish the reason for an outcome, a participant-level benefit, or the result of analyses that are not posted. These data should be interpreted as statistical summaries of lesion patency, with the stated reporting limitations, rather than as a complete account of every trial outcome.
13. Why This Trial Matters Statistically
This trial raises a central biostatistical issue: the unit used for analysis differs from the participant count. The primary endpoint is lesion-based, and participants may contribute more than one lesion. The registry reports 222 subjects representing 254 lesions in the paclitaxel-coated arm and 72 subjects representing 79 lesions in the bare-balloon arm. Distinguishing participants from lesions is essential when reading denominators and interpreting uncertainty.
In general, multiple observations from one participant may be statistically dependent. If that dependence is ignored, the apparent amount of information can be overstated and uncertainty can be mischaracterized. The registry record does not say how the analysis handled multiple lesions per participant. That missing detail limits evaluation of the reported confidence intervals and any possible treatment comparison.
The record also illustrates why arm-specific percentages should not be mistaken for a comparative analysis. It reports patency estimates of 83.9% and 60.6%, each with a 95% confidence interval, but does not post an effect estimate or test comparing groups. Confidence intervals around separate arm estimates describe those estimates; they do not directly quantify the uncertainty in the contrast of interest. The absence of a posted comparison is especially relevant for a randomized trial, where the group contrast is often the main inferential question.
Finally, the endpoint population is incompletely described for the bare-balloon arm. The record gives the number of lesions and subjects but not the number of evaluable lesions. This makes transparency about outcome availability and analysis denominators important. Together, the lesion-level unit, missing evaluability detail, and absence of a direct comparison analysis show why registry percentages need to be read alongside their design and reporting limits.
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.
The primary endpoint is reported as a percentage of lesions, while the intervention groups are also described by numbers of subjects. In the paclitaxel-coated arm, 222 subjects represent 254 lesions, and 224 lesions were evaluable. In the bare-balloon arm, 72 subjects represent 79 lesions, but the number evaluable is not reported in the registry record. This prevents a complete comparison of endpoint availability between arms.
The registry gives arm-level percentages and 95% confidence intervals but no direct comparison analysis. The method used to calculate the intervals, the treatment-effect estimate, and any p-value are not reported in the registry record. The record also does not report whether the analysis accounted for multiple lesions from the same participant, or whether any covariates were included.
Although the study is described as randomized and single-blinded, further details about allocation procedures and masking are not reported in the registry record. The record does not report the sample-size justification or interim analysis plan. It also does not provide posted secondary outcome results or describe adjustment for multiple analyses.
Missing endpoint data are not fully characterized. The number of evaluable lesions is stated for the paclitaxel-coated arm but not for the bare-balloon arm, and reasons for non-evaluability, missing-data methods, and sensitivity analyses are not reported in the registry record. These limitations restrict assessment of the precision and comparability of the arm estimates, even though confidence intervals are listed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: ILLUMENATE EU Randomized Clinical Trial — NCT01858363.
- Registry record last updated 2021-10-13; status last verified 2021-10.
- Results first posted 2021-10-13.
- 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
ILLUMENATE EU was a completed, prospective, randomized, multi-center, single-blinded, parallel-group trial with listed enrollment of 294. It compared a paclitaxel-coated percutaneous transluminal angioplasty balloon catheter with a bare balloon for de novo or recurrent lesions of the superficial femoral or popliteal arteries.
The primary endpoint was lesion-level patency at 12 months, defined by absence of restenosis using duplex ultrasound peak systolic velocity ratio ≤2.5 and freedom from clinically-driven target lesion revascularization. Reported patency was 83.9% with a 95% confidence interval of 78.5% to 88.5% in the paclitaxel-coated arm, and 60.6% with a 95% confidence interval of 47.8% to 72.4% in the bare-balloon arm.
No direct primary-endpoint comparison analysis or secondary outcome results are posted. The evaluable lesion count for the bare-balloon arm, the confidence-interval method, and the handling of multiple lesions per participant are not reported in the registry record.