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).
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 Type
OBSERVATIONAL
Enrollment
20
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.
CaritasKlinikum, St. Theresia
Saarbrücken, Saarland, Germany
Clinically driven target lesion revascularization (TLR)
clinically driven target lesion revascularization
Time frame: 6 months
clinically driven target vessel revascularization (TVR)
TVR
Time frame: 6 months
Binary restenosis
Peak Systolic velocity (PSV) \>2.4
Time frame: 6 months
Change in Ankle Brachial Index (ABI)
Change in ankle brachial index from baseline.
Time frame: 6 months
Change in Rutherford-classification
Change in Rutherford-Classification from Baseline (I-VI)
Time frame: 6 months
major cardiac adverse events
myocardial infarction, stroke, death, cardiovascular death
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
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Change in Ankle Brachial Index (ABI)
Time frame: 12 months
Change in Rutherford-classification
Time frame: 12 months
major cardiac adverse events
myocardial infarction, stroke, death, cardiovascular death
Time frame: 12 months
Amputation
Time frame: 12 months