N/A
Completed N=294
ILLUMENATE EU Randomized Clinical Trial
Peripheral arterial disease · Claudication
Source: ClinicalTrials.gov NCT01858363 ↗
Enrolled (actual)
294
Serious AEs
54.4%
Results posted
Oct 2021
Primary outcomePrimary: Patency at 12-months — 83.9; 60.6 percentage of lesions
Summary
This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the treatment of patients with de novo occluded/stenotic or reoccluded/restenotic lesions of the superficial femoral (SFA) and popliteal arteries.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patency at 12-months |
83.9; 60.6 | — |
| PRIMARY Percentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month |
94.1; 83.3 | — |
Eligibility Criteria
Inclusion Criteria
- Symptomatic leg ischemia requiring treatment of the superficial femoral or popliteal arteries
- Rutherford clinical category 2, 3 or 4
- Male or non-pregnant female at least 18 years
Exclusion Criteria
- Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries
- Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
- Known intolerance of study medications, paclitaxel or contrast agent
- Active participation in another investigational device or drug study
Data sourced from ClinicalTrials.gov (NCT01858363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.