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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02701543 on ClinicalTrials.gov