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

University Hospital, Saarland

Status and phase: Completed; Phase 2; Phase 1

Conditions: Peripheral Arterial Disease

Treatments: Device: paclitaxel coated balloon catheter (device with drug)

Study type: Interventional

Funder types: Other

Identifiers

NCT00472472

PACCOCATH - FEM I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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87 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

PTA

Treatment:

Device: paclitaxel coated balloon catheter (device with drug)

2

Active Comparator group

Description:

PTA with Paccocath

Treatment:

Device: paclitaxel coated balloon catheter (device with drug)