Status:
COMPLETED
Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon
Lead Sponsor:
Spectranetics Corporation
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.
Detailed Description
The ILLUMENATE Pivotal study is a prospective, randomized, multi-center, single-blind study which will include up to 360 subjects in approximately forty-five (45) sites across the United States to eva...
Eligibility Criteria
Inclusion
- Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.
Exclusion
- Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated
Key Trial Info
Start Date :
June 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2018
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01858428
Start Date
June 18 2013
End Date
March 19 2018
Last Update
August 24 2020
Active Locations (44)
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1
Yuma Regional Medical Center
Yuma, Arizona, United States, 85364
2
Mission Cardiovascular Research Institute
Fremont, California, United States, 94538
3
Good Samaritan Hospital - Los Angeles
Los Angeles, California, United States, 90017
4
Medical Center of the Rockies
Loveland, Colorado, United States, 80538