Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00472472

Acronym

PACCOCATH_F

Enrollment

Registered

2007-05-11

Start date

2004-04-30

Completion date

2007-07-31

Last updated

2010-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

restenosis, peripheral arterial disease, paccocath, drug-coated balloon

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.

Interventions

DEVICEpaclitaxel coated balloon catheter (device with drug)

PTA vs Paccocath

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

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

Design outcomes

Primary

Measure	Time frame
angiographic late lumen loss	6 months

Secondary

Measure	Time frame
binary restenosis rate; major adverse events	18 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026