Evaluation of Standard of Care Practices, Procedural Outcomes and In-hospital Complications of Peripheral Endovascular Procedures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Multicenter, Observational Study Evaluating Standard of Care Practices, Procedural Outcomes, and In-hospital Complications of Endovascular Procedures for Treatment of Atherosclerotic Lesions in the Infrainguinal Arteries

Conditions
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Peripheral Arterial Disease

Participation Criteria
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Eligibility Criteria
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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: Subject has a single target lesion that involves both ATK and BTK segment. Subject not suitable for receiving endovascular procedures of lower limb arteries Prior planned major amputation in the target limb (above the ankle) Subject with previous bypass surgery of target vessel. History of any open surgical procedure within the past 30 days. Planned vascular surgery procedure within the next 30 days after the ATK and/or BTK procedure on the target limb. Note: The inflow vessels can be treated on the day of the procedure Subject under dialysis Subject currently enrolled in another investigational device, biologic, or drug trial in which the primary endpoint has not yet been reached Subject lacking capacity to provide informed consent Subject under judicial protection, tutorship, or curatorship (for France only)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Above the knee (ATK) group<br>Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau) | |
| Below the knee (BTK) group<br>Target lesions involve arteries below the tibial plateau | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success rate | Combination of technical success and absence of procedural complications | Index Procedure | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |