Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: paclitaxel coated balloon catheter (device with drug)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| angiographic late lumen loss |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| binary restenosis rate; major adverse events |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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restenosis, peripheral arterial disease, paccocath, drug-coated balloon