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The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635 or Qualimed Pontos-pp) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperative complications, technical success, target lesion revascularization, amputation and clinical outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with peripheral artery disease | located in the common and external iliac artery, the common and superficial femoral artery, the popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular intervention | Device | Endovascular treatment with stent or balloon according to current practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binary restenosis | Binary restenosis defined as ≥ 50% re-obstruction of the target lesion will be assessed by duplex ultrasound (peak systolic ratio >2.4) | at 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Device-related complications | Registration of peri- and early/late postoperative complications | up to 12 months follow-up |
| Immediate procedural outcome | The combination of technical success defined as a successful access and deployment of the device and achievement of a final residual diameter stenosis of <30% of the treated target lesion on the procedural completion angiography and procedural success defined as a combination of technical success and absence of procedural complications. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with peripheral artery disease, located in the common and external iliac artery, the common and superficial femoral artery, the popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heilig Hart Ziekenhuis | Mol | Antwerp | 2400 | Belgium |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| during index-procedure |
| Clinical outcome | Rutherford classification | at baseline |
| Clinical outcome | Rutherford classification | at 6 weeks follow-up |
| Clinical outcome | Rutherford classification | at 12 months follow-up |
| Primary sustained clinical improvement | defined as sustained upward shift of ≥ 1 category on Rutherford classification without the need for repeated TLR in surviving patients. | at 12 months follow-up |
| Secondary sustained clinical improvement | defined as sustained upward shift of ≥ 1 category on Rutherford classification including the need for repeated TLR in surviving patients. | at 12 months follow-up |
| Target lesion revascularization (TLR) | defined as an endovascular or surgical treatment due to a problem arising from the lesion (+1cm proximally and distally to include edge phenomena). | up to 12 months follow-up |
| Mortality | Procedure-related and all-cause mortality. | up to 12 months follow-up |
| Amputation | minor amputation defined as below the ankle and major defined as above the ankle. | up to 12 months follow-up |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |