Cutting-balloon, Drug-coated-balloon, Femoropoliteal Stenosis/Occlusion, Peripheral Artery Disease
Conditions
Keywords
PAD, femoropoliteal stenosis/occlusion, cutting-balloon, drug-coated-balloon
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).
Interventions
DEVICECutting-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.
Sponsors
Caritasklinik St. Theresia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically driven target lesion revascularization (TLR) | 6 months | clinically driven target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binary restenosis | 6 months | Peak Systolic velocity (PSV) \>2.4 |
| Change in Ankle Brachial Index (ABI) | 6 months | Change in ankle brachial index from baseline. |
| Change in Rutherford-classification | 6 months | Change in Rutherford-Classification from Baseline (I-VI) |
| clinically driven target vessel revascularization (TVR) | 6 months | TVR |
| Amputation | 6 months | — |
| Clinically driven target lesion revascularization (TLR) | 12 months | — |
| major cardiac adverse events | 6 months | myocardial infarction, stroke, death, cardiovascular death |
Countries
Germany
Outcome results
None listed