NCT02198105

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Caritasklinik St. Theresia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Peripheral Artery Disease
• Femoropoliteal Stenosis/Occlusion
• Cutting-balloon
• Drug-coated-balloon

Interventions

Type	Name	Description
DEVICE	Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA	Interventional procedure: 1. PTA with Cutting-Balloon (60-120 seconds). 2. PTA with DC-Balloon (60 seconds). Technical success is defined as 1. no recoil \>30% 2. no dissection \>Type B 3. no stenting \>30% of lesion length.

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-10-01
• Completion: 2016-11-01
• First posted: 2014-07-23
• Last updated: 2016-07-22

Locations

1 site across 1 country: Germany