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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:
Technical success is defined as
Follow-up of patients after 6 months and 12 months (ABI, Rutherford-classification, MACE, TLR, TVR, Binary Restenosis).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoropopliteal stenosis | Consecutive patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis/occlusion. Intervention with Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon-PTA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA | Device | Interventional procedure:
Technical success is defined as
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinically driven target lesion revascularization (TLR) | clinically driven target lesion revascularization | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| clinically driven target vessel revascularization (TVR) | TVR | 6 months |
| Binary restenosis | Peak Systolic velocity (PSV) >2.4 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic peripheral artery disease due to femoro-popliteal stenosis or occlusion.
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Baumhäkel, MD | CaritasKlinikum, St. Theresia Saarbrücken, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CaritasKlinikum, St. Theresia | Saarbrücken | Saarland | 66113 | Germany |
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|
| Change in Ankle Brachial Index (ABI) | Change in ankle brachial index from baseline. | 6 months |
| Change in Rutherford-classification | Change in Rutherford-Classification from Baseline (I-VI) | 6 months |
| major cardiac adverse events | myocardial infarction, stroke, death, cardiovascular death | 6 months |
| Amputation | 6 months |
| clinically driven target vessel revascularization (TVR) | 12 months |
| Clinically driven target lesion revascularization (TLR) | 12 months |
| Binary restenosis | 12 months |
| Change in Ankle Brachial Index (ABI) | 12 months |
| Change in Rutherford-classification | 12 months |
| major cardiac adverse events | myocardial infarction, stroke, death, cardiovascular death | 12 months |
| Amputation | 12 months |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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