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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00472472
First received: May 10, 2007
Last updated: June 29, 2010
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease
Device: paclitaxel coated balloon catheter (device with drug)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paclitaxel Coated Balloon Catheter for Inhibition of Restenosis in Femoropopliteal Arteries (PACCOCATH - FEM I)

Resource links provided by NLM:


Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • angiographic late lumen loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • binary restenosis rate; major adverse events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 87
Study Start Date: April 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472472

Locations
Germany
Klinik für Strahlenheilkunde, Charité Campus Virchow Klinikum
Berlin, Germany, 13353
Institut für Diagnostische Radiologie und Neuroradiologie, Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität
Greifswald, Germany, 17487
Sponsors and Collaborators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charite Hospital, Berlin
ClinicalTrials.gov Identifier: NCT00472472     History of Changes
Other Study ID Numbers: PACCOCATH - FEM I
Study First Received: May 10, 2007
Last Updated: June 29, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Saarland:
restenosis
peripheral arterial disease
paccocath
drug-coated balloon

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014