Overview

This trial is active, not recruiting.

Conditions peripheral artery disease, femoropoliteal stenosis/occlusion, cutting-balloon, drug-coated-balloon
Treatment cutting-balloon-pta (vascutrak) and drug coated ballon pta
Sponsor Caritasklinik St. Theresia
Start date May 2014
End date October 2016
Trial size 20 participants
Trial identifier NCT02198105, DEBTRAK-Registry

Summary

Observational registry including patients with peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis/occlusion. Intervention with Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon-PTA.
cutting-balloon-pta (vascutrak) and drug coated ballon pta
Interventional procedure: PTA with Cutting-Balloon (60-120 seconds). PTA with DC-Balloon (60 seconds). Technical success is defined as no recoil >30% no dissection >Type B no stenting >30% of lesion length.

Primary Outcomes

Measure
Clinically driven target lesion revascularization (TLR)
time frame: 6 months

Secondary Outcomes

Measure
clinically driven target vessel revascularization (TVR)
time frame: 6 months
Binary restenosis
time frame: 6 months
Change in Ankle Brachial Index (ABI)
time frame: 6 months
Change in Rutherford-classification
time frame: 6 months
major cardiac adverse events
time frame: 6 months
Amputation
time frame: 6 months
clinically driven target vessel revascularization (TVR)
time frame: 12 months
Clinically driven target lesion revascularization (TLR)
time frame: 12 months
Binary restenosis
time frame: 12 months
Change in Ankle Brachial Index (ABI)
time frame: 12 months
Change in Rutherford-classification
time frame: 12 months
major cardiac adverse events
time frame: 12 months
Amputation
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - peripheral artery disease (PAD) with femoro-popliteal stenosis >70% or occlusion (vessel diameter 4-6mm) - age 18-99 - informed consent Exclusion Criteria: - proximal / iliacal stenosis - stenosis/occlusion of all arteries below the knee

Additional Information

Official title Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion.
Principal investigator Magnus Baumhäkel, MD
Description The registry includes consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis or occlusion treated with cutting ballon- and subsequent drug-coated-ballon-percutaneous-transluminal-angioplasty (PTA). Interventional procedure: 1. PTA with Cutting-Balloon (60-120 seconds). 2. PTA with Drug-Coated-Balloon (60 seconds). Technical success is defined as 1. no recoil >30% 2. no dissection >Type B 3. no stenting >30% of lesion length. Follow-up of patients after 6 months and 12 months (ABI, Rutherford-classification, MACE, TLR, TVR, Binary Restenosis).
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Caritasklinik St. Theresia.