Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries (PACCOCATH_F)

June 29, 2010 updated by: University Hospital, Saarland

Paclitaxel Coated Balloon Catheter for Inhibition of Restenosis in Femoropopliteal Arteries (PACCOCATH - FEM I)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Treatment of patients with peripheral arterial disease (PAD) in the femoropopliteal arteries by percutaneous intervention is still limited by high rates of restenosis. The aim of the present study is to evaluate the efficacy and safety of a novel method of short time local drug delivery based on a paclitaxel-coated balloon in femoropopliteal arteries.

Methods and results: The double-blind and randomized study enrolled n=79 patients with occlusion or stenosis of femoropopliteal arteries. Inclusion criteria were clinical Rutherford stage 1-5, occlusion or hemodynamic relevant stenosis (≥ 70 % diameter) of femoropopliteal arteries and successful guiding wire recanalization. The primary endpoint was the late lumen loss after 6 months follow-up as seen in angiography. Secondary endpoints included the rate of restenosis (a binary variable), change of ankle brachial index (ABI), rutherford class and major adverse events.

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Klinik für Strahlenheilkunde, Charité Campus Virchow Klinikum
      • Greifswald, Germany, 17487
        • Institut für Diagnostische Radiologie und Neuroradiologie, Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Rutherford stage 1, 2, 3, 4 oder 5
  • Occlusion or Stenosis of Superficial femoral and/or popliteal artery
  • Successful guide wire passage of the lesion
  • Patient suitable of vascular surgery in case of complication
  • Written consent
  • Patient is willing to take part in follow up examinations within the study

Exclusion Criteria:

  • Acute ischemia
  • Distal run off less than one vessel
  • Pregnancy
  • Hyperthyroidism
  • Thrombocytes <100.000/mm3 or >700.000/mm3, Leucocytes <3.000/mm3
  • Life expectancy less than two years
  • Patients not willing to enter the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
PTA
Device: paclitaxel coated balloon catheter (device with drug)
PTA vs Paccocath
Active Comparator: 2
PTA with Paccocath
Device: paclitaxel coated balloon catheter (device with drug)
PTA vs Paccocath

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
angiographic late lumen loss
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
binary restenosis rate; major adverse events
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

Investigators

  • Principal Investigator: Jens Ricke, MD, Klinik für Strahlenheilkunde, Charité Campus Virchow, Augustenburger Platz 1, 13353 Berlin, Germany
  • Study Director: Ulrich Speck, PhD, Radiologie, Campus Mitte, Charite, 10117 Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

May 10, 2007

First Submitted That Met QC Criteria

May 10, 2007

First Posted (Estimate)

May 11, 2007

Study Record Updates

Last Update Posted (Estimate)

June 30, 2010

Last Update Submitted That Met QC Criteria

June 29, 2010

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PACCOCATH - FEM I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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