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Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. However, there are still lack of data on procedural outcomes, in-hospital complications, and resource utilization on treatment of (complex) lesions in the femoral, popliteal and infrapopliteal artery in the real-world condition in Europe.
The study will enroll consecutive eligible subjects who have peripheral artery disease (PAD) requiring endovascular treatment of de-novo and restenotic atherosclerotic lesions in femoral, popliteal and infrapopliteal arteries.
The purpose of this prospective, multicenter, observational European Study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications of endovascular peripheral interventions for treatment of lesions in the femoral, popliteal and infrapopliteal arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Above the knee (ATK) group | Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau) | ||
| Below the knee (BTK) group | Target lesions involve arteries below the tibial plateau |
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| Measure | Description | Time Frame |
|---|---|---|
| Procedural success rate | Combination of technical success and absence of procedural complications | Index Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure technical success rate | successful crossing and achievement of a final residual diameter stenosis of ≤30% of the treated target lesion on the procedural completion angiography | Index Procedure |
| Rate of target lesion bailout stenting |
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Inclusion Criteria:
Subject ≥18 years old
Subject has provided written informed consent
Subject has Rutherford classification 2 to 6
Reference vessel diameter ≥2 and ≤7 mm
Target lesion(s) has stenosis >70% by visual assessment
Multiple consecutive single lesions with a healthy segment(s) of ≤ 3cm in-between the lesions will be considered one lesion.
For Above the knee (ATK) group
Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)
At least 1 below-knee artery patent to the ankle
Successful treatment of inflow iliac stenosis to the target lesion. Inflow lesion stenosis can be treated during the same procedure as per local standard of care.
For Below the knee (BTK) group:
Target lesions involve arteries below the tibial plateau
Successful treatment of inflow vessel (from ipsilateral iliac to the target lesion) resulting in ≤30% residual stenosis with no evidence of embolization or significant complications.
Exclusion Criteria:
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Subjects who have PAD with target lesion(s) located in the femoral, popliteal and/or infrapopliteal artery are eligible for the study. Up to 380 subjects will be enrolled in approximately 12 investigational sites in Europe.
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| Name | Affiliation | Role |
|---|---|---|
| Deloose Koen, Dr | AZ Saint Blasius, Dendermonde, Belgium | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Univ.-Klinikum Graz, Ambulanz für Angiologie | Graz | Austria | ||||
| Ziekenhuis Oost Limburg |
The individual participant data (IPD) is not yet drafted. No decision is taken to share it yet.
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Stented target lesion
| Index Procedure |
| Stented length | Stented length | Index Procedure |
| Rate of PTA balloon related flow-limiting dissections | PTA balloon related flow-limiting dissections | Index Procedure |
| Rate of distal embolization | Distal embolization | Index Procedure |
| Rate of target vessel rupture | Target vessel rupture | Index Procedure |
| Rate of target vessel perforation | Target vessel perforation | Index Procedure |
| Rate of acute occlusion | Acute occlusion | Index Procedure |
| Primary crossing success rate | Successfully placement of a guidewire into the distal true lumen with the primary crossing strategy | Index Procedure |
| Rate of Serious Adverse Device Effects | Serious Adverse Device Effects | Index Procedure |
| Non-labor resource use | Devices use | Index procedure until discharge |
| Genk |
| Genk |
| 3600 |
| Belgium |
| OLV Ziekenhuis Aalst | Aalst | Belgium |
| A.Z. Sint-Blasius | Dendermonde | Belgium |
| University Hospital Ghent | Ghent | 9000 | Belgium |
| vzw AZ Groeninge | Kortrijk | 8500 | Belgium |
| Hopital Paris Saint Joseph | Paris | France |
| Universitätsklinikum Tübingen | Tübingen | Tübingen | 72076 | Germany |
| Karolinen-Hospital, Klinikum Arnsberg | Arnsberg | Germany |
| Sank Gertrauden-Krankenhaus | Berlin | Germany |
| Semmelweis University Hospital | Budapest | Hungary |
| Policlinico Abano Terme | Abano Terme | Abano Terme | 35031 | Italy |
| Azienda Usl Toscana sud est | Arezzo | Arezzo | 52100 | Italy |
| ospedaliero-universitaria Senese | Siena | 53100 | Italy |
| Hospital General de Guadalajara | Guadalajara | Spain |
| Ospedale Regionale di Lugano | Lugano | Lugano | 6962 | Switzerland |
| KS Winterthur | Winterthur | Switzerland |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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