Status:
COMPLETED
ILLUMENATE EU Randomized Clinical Trial
Lead Sponsor:
Spectranetics Corporation
Conditions:
Peripheral Arterial Disease
Claudication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
294 Patients enrolled
Trial Details
Trial ID
NCT01858363
Start Date
November 1 2012
End Date
October 1 2020
Last Update
October 13 2021
Active Locations (1)
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1
Center for Diagnostic Radiology and Minimally Invasive Therapy
Berlin, Germany