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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
30
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).
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).
University Hospital Essen
Essen, North Rhine-Westphalia, Germany
RECRUITINGTreatment-Emerged Adverse Events
Incidence of Treatment-Emerged Adverse Events as assessed by angiography and adverse event assessment
Time frame: 6 months Follow Up
Primary patency
determined through doppler ultrasound
Time frame: 6 months Follow Up
Bail-out stent rate
success of atherectomy in the SFA including the bail-out stenting rates
Time frame: 6 months Follow Up
FMD local
Local endothelial function and vasomotion testing as determinded by FMD of the femoral artery
Time frame: 6 months Follow Up
Vessel stiffness
Vascular stiffness determined through pulse wave velocity (PWV)
Time frame: 6 months Follow Up
target lesion revascularization
freedom from Target Lesion Revascularization (FTLR) is defined as the Need for percutaneous or interventional revascularization
Time frame: 6 months Follow Up
ABI (Ankle Brachial Index)
Ankle Brachial Index assessed by Doppler
Time frame: 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)
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Time frame: 6 months Follow Up
Change in Plaque burden
Change in plaque burden is measured by plaque volume change using intravascular ultrasound (IVUS)
Time frame: during baseline visit
Change in plaque characteristic
Change in plaque characteristic is quantified using virtual histology using intravascular ultrasound (IVUS)
Time frame: during baseline visit