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Paclitaxel Eluting Balloon and Conventional Balloon for In-Stent Restenosis of the Superficial Femoral Artery

NCT01083394 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2014-03-10

No results posted yet for this study

Summary

The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral artery in-stent restenosis.

Conditions

  • Peripheral Vascular Disease

Interventions

DEVICE

PTA

PTA using a conventional balloon

DEVICE

PTA with PEB

PTA using a paclitaxel eluting balloon

PROCEDURE

Percutaneous Transluminal Angioplasty (PTA)

Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon

Sponsors & Collaborators

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Adnan Kastrati, MD · Deutsches Herzzentrum Muenchen

  • Ilka V. Ott, MD · Klinikum rechts der Isar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • Germany

Study Locations

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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 NCT01083394 on ClinicalTrials.gov