Registry of Cutting Balloon and DCB Intervention in Femoropopliteal Stenosis/Occlusion. (DEBTRAK)

Caritasklinik St. Theresia

Status: Unknown

Conditions: Cutting-balloon; Peripheral Artery Disease; Femoropoliteal Stenosis/Occlusion; Drug-coated-balloon

Treatments: Device: Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA

Study type: Observational

Funder types: Other

Identifiers

NCT02198105

DEBTRAK-Registry

Details and patient eligibility

About

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).

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Femoropopliteal stenosis

Description:

Consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis/occlusion. Intervention with Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon-PTA.

Treatment:

Device: Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA