SAVioR: Safety and Efficacy of Atherectomy on VasculaR Functions
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Atherectomy Atherectomy and drug-coated balloon (DCB) |
Other: Atherectomy
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).
|
| Active Comparator: Standard care Standard care with predilation (POBA) and DCB |
Other: POBA and DCB
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).
|
Outcome Measures
Primary Outcome Measures
- Treatment-Emerged Adverse Events [6 months Follow Up]
Incidence of Treatment-Emerged Adverse Events as assessed by angiography and adverse event assessment
- Primary patency [6 months Follow Up]
determined through doppler ultrasound
Secondary Outcome Measures
- Bail-out stent rate [6 months Follow Up]
success of atherectomy in the SFA including the bail-out stenting rates
- FMD local [6 months Follow Up]
Local endothelial function and vasomotion testing as determinded by FMD of the femoral artery
- Vessel stiffness [6 months Follow Up]
Vascular stiffness determined through pulse wave velocity (PWV)
- target lesion revascularization [6 months Follow Up]
freedom from Target Lesion Revascularization (FTLR) is defined as the Need for percutaneous or interventional revascularization
- ABI (Ankle Brachial Index) [6 months Follow Up]
Ankle Brachial Index assessed by Doppler
- Systemic endothelial function [6 months Follow Up]
Change of endothelial function, assessed by the change in the vasodilation after reactive hyperaemia of the brachial artery (flow-mediated dilation = FMD)
- Change in Plaque burden [during baseline visit]
Change in plaque burden is measured by plaque volume change using intravascular ultrasound (IVUS)
- Change in plaque characteristic [during baseline visit]
Change in plaque characteristic is quantified using virtual histology using intravascular ultrasound (IVUS)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Peripheral artery disease, lesions in the SFA and popliteal artery.
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Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, or 4
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Planed peripheral intervention TASC A-D
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Subject must be between 18 and 85 years old
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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
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Vessel diameter ≥3.0 mm and ≤7.0 mm
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Willing to comply with the specified follow-up evaluation
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Written informed consent prior to any study procedures
Exclusion Criteria:
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Thrombolysis within 72 hours prior to the index procedure
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Aneurysm in the femoral artery or popliteal artery
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Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
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Unstable angina pectoris at the time of the enrollment
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Recent myocardial infarction or stroke < 30 days prior to the index procedure
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Life expectancy less than 12 months
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Septicemia at the time of enrollment
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Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Essen | Essen | NRW | Germany | 45122 |
Sponsors and Collaborators
- University Hospital, Essen
- Straub Medical AG
Investigators
- Principal Investigator: Christos Rammos, Universität Duisburg-Essen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SAVioR_CR