Safety and Efficacy of Atherectomy on VasculaR Functions

Study Overview
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Brief Summary
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Interventional strategies aim to restore tissue perfusion. However, despite the simple reopening of a narrowed artery they affect endothelial function, perpetuating dysfunctional vascular homeostasis. PTA and atherectomy might alter the endothelial function but the mechanisms are incompletely understood. The primary goal of atherectomy is vessel preparation and improving compliance, which could aid in preserving vessel functions. Aim of this study is to determine safety, efficacy, patency and vessel functions in the femoropopliteal artery following atherectomy and DCB.

Official Title
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Safety and Efficacy of Interventional Treatment Through Atherectomy to Improve Vascular Functions and Patency in Symptomatic Peripheral Artery Disease - Pilot Study

Conditions
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Peripheral Arterial Disease, Claudication, Intermittent

Intervention / Treatment
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* Other: Atherectomy
* Other: POBA and DCB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Peripheral artery disease, lesions in the SFA and popliteal artery. Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, or 4 Planed peripheral intervention TASC A-D Subject must be between 18 and 85 years old Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation Vessel diameter ≥3.0 mm and ≤7.0 mm Willing to comply with the specified follow-up evaluation Written informed consent prior to any study procedures Exclusion Criteria: Thrombolysis within 72 hours prior to the index procedure Aneurysm in the femoral artery or popliteal artery Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy Unstable angina pectoris at the time of the enrollment Recent myocardial infarction or stroke < 30 days prior to the index procedure Life expectancy less than 12 months Septicemia at the time of enrollment Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb Known or suspected allergies or contraindications to aspirin, clopidogrel or heparin Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atherectomy<br>Atherectomy and drug-coated balloon (DCB) | Other: Atherectomy<br>* Straub Rotarex S atherectomy and drug-coated balloon DCB. Predilation of the lesion with a predefined ballon (180 sec, Passeo-18). Thus, no direct DCB will be conducted. All DCB lengths (40mm to 200 mm) and Diameters (3mm to 7mm) are eligible for the Trial as long as used in the superficial femoral artery (SFA).<br>|
| Active Comparator: Standard care<br>Standard care with predilation (POBA) and DCB | Other: POBA and DCB<br>* Standard predilation (POBA) and DCB. Predilation of the lesion with a predefined ballon (180 sec, Passeo-18). Thus, no direct DCB will be conducted. All DCB lengths (40mm to 200 mm) and Diameters (3mm to 7mm) are eligible for the Trial as long as used in the superficial femoral artery (SFA).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-Emerged Adverse Events | Incidence of Treatment-Emerged Adverse Events as assessed by angiography and adverse event assessment | 6 months Follow Up | 
| Primary patency | determined through doppler ultrasound | 6 months Follow Up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bail-out stent rate | success of atherectomy in the SFA including the bail-out stenting rates | 6 months Follow Up | 
| FMD local | Local endothelial function and vasomotion testing as determinded by FMD of the femoral artery | 6 months Follow Up | 
| Vessel stiffness | Vascular stiffness determined through pulse wave velocity (PWV) | 6 months Follow Up | 
| target lesion revascularization | freedom from Target Lesion Revascularization (FTLR) is defined as the Need for percutaneous or interventional revascularization | 6 months Follow Up | 
| ABI (Ankle Brachial Index) | Ankle Brachial Index assessed by Doppler | 6 months Follow Up | 
| Systemic endothelial function | Change of endothelial function, assessed by the change in the vasodilation after reactive hyperaemia of the brachial artery (flow-mediated dilation = FMD) | 6 months Follow Up | 
| Change in Plaque burden | Change in plaque burden is measured by plaque volume change using intravascular ultrasound (IVUS) | during baseline visit | 
| Change in plaque characteristic | Change in plaque characteristic is quantified using virtual histology using intravascular ultrasound (IVUS) | during baseline visit |