Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries

NCT00472472 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2010-06-30

No results posted yet for this study

Summary

The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis after femoropopliteal angioplasty.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

paclitaxel coated balloon catheter (device with drug)

PTA vs Paccocath

Sponsors & Collaborators

  • University Hospital, Saarland

    lead OTHER

Principal Investigators

  • Jens Ricke, MD · Klinik für Strahlenheilkunde, Charité Campus Virchow, Augustenburger Platz 1, 13353 Berlin, Germany

  • Ulrich Speck, PhD · Radiologie, Campus Mitte, Charite, 10117 Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2007-07-31
Completion
2007-07-31

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 NCT00472472 on ClinicalTrials.gov