Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease
NCT02701543 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 414
Last updated 2023-12-20
Summary
To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in Superficial femoropopliteal artery (SFA )and/or Proximal Popliteal Artery in Peripheral Artery Disease (PAD) patients with Rutherford class 2-4.
Conditions
Interventions
- DEVICE
-
Ranger Drug Eluting Balloon
Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
- DEVICE
-
In Pact Drug Eluting Balloon
Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
Sponsors & Collaborators
-
University of Leipzig
lead OTHER
Principal Investigators
-
Dierk Scheinert, Prof.Dr. · University Leipzig
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-10-31
- Primary Completion
- 2018-10-31
- Completion
- 2023-12-31
Countries
- Germany
Study Locations
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