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

• Conditions: Femoropoliteal Stenosis/Occlusion; Peripheral Artery Disease; Cutting-balloon; Drug-coated-balloon
• Interventions: Device: Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA

• Registration Number: NCT02198105
• Lead Sponsor: Caritasklinik St. Theresia

Brief 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).

Detailed 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).

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-23
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-21
• Last Update Posted: 2016-07-22
• Primary Completion: 2016-10
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinically driven target lesion revascularization (TLR)	6 months	clinically driven target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
Binary restenosis	12 months
clinically driven target vessel revascularization (TVR)	12 months
Change in Ankle Brachial Index (ABI)	12 months
Change in Rutherford-classification	12 months
Amputation	12 months
major cardiac adverse events	12 months	myocardial infarction, stroke, death, cardiovascular death
Clinically driven target lesion revascularization (TLR)	12 months

Trial Locations

Locations (1)

CaritasKlinikum, St. Theresia; 🇩🇪 Saarbrücken, Saarland, Germany