Claudication, Intermittent, Peripheral Arterial Disease
Conditions
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.
Interventions
OTHERAtherectomy
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).
OTHERPOBA 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).
Sponsors
Straub Medical AG
University Hospital, Essen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Bail-out stent rate | 6 months Follow Up | success of atherectomy in the SFA including the bail-out stenting rates |
| 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) |
| 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) |
| FMD local | 6 months Follow Up | Local endothelial function and vasomotion testing as determinded by FMD of the femoral artery |
Countries
Germany
Contacts
Primary ContactChristos Rammos
Outcome results
None listed