Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries

Phase 1

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: paclitaxel coated balloon catheter (device with drug)

• Registration Number: NCT00472472
• Lead Sponsor: University Hospital, Saarland

Brief 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.

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 Timeline

• Study Start: 2004-04
• Status Verified: 2007-05
• Study First Submitted: 2007-05-10
• Study First Submitted QC: 2007-05-10
• Study First Posted: 2007-05-11
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Last Update Submitted: 2010-06-29
• Last Update Posted: 2010-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	paclitaxel coated balloon catheter (device with drug)	PTA
2	paclitaxel coated balloon catheter (device with drug)	PTA with Paccocath

Primary Outcome Measures

Name	Time	Method
angiographic late lumen loss	6 months

Secondary Outcome Measures

Name	Time	Method
binary restenosis rate; major adverse events	18 months

Trial Locations

Locations (2)

Klinik für Strahlenheilkunde, Charité Campus Virchow Klinikum; 🇩🇪 Berlin, Germany

Institut für Diagnostische Radiologie und Neuroradiologie, Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität; 🇩🇪 Greifswald, Germany