An interventional study of Angioplasty and drug coated balloon of the superficial femoral artery (SFA) and Angioplasty and stenting of the superficial femoral artery (SFA) in Peripheral Arterial Disease and Claudication, Intermittent, sponsored by University Hospital, Essen. Status unknown at 1 site in Germany. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-01-22.
Sponsored by University Hospital, Essen · Not applicable, Interventional, and Basic science
Endovascular treatment of the superficial femoral artery has a high initial success rate, but restenosis occurs in up to 60% of cases. While restoration of tissue perfusion is achieved, interventional strategies affect endothelial function. Endothelial dysfunction is the pathophysiologic principle involved in the initiation and progression of arteriosclerosis.
The aim of this study is to determine the impact of endovascular strategies in the superficial femoral artery on local and systemic endothelial and vascular function.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's planned enrollment of 30 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →University Hospital, Essen is the lead sponsor of 111 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Procedure: Angioplasty and drug coated balloon of the superficial femoral artery (SFA)
Procedure: Angioplasty and stenting of the superficial femoral artery (SFA)
In case of drug coated balloon (DCB) there should be always a 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)
In case of stent application there should be always a predilation of the lesion with a predefined ballon (180 sec, Passeo-18). In case of stenting there should be a strong effect on vasomotion of the treated vessel area. All Stent lengths (40mm to 200 mm) and Diameters (5mm to 7mm) are eligible for the trial as long as used in the superficial femoral artery (SFA)
local endothelial function
Change of endothelial function, assessed by the change in the vasodilatative reserve of the femoral artery (flow-mediated dilation = FMD)
Time frame: 6 months Follow Up
Systemic endothelial function
1.Change of endothelial function, assessed by the change in the vasodilatative reserve of the brachial artery (flow-mediated dilation = FMD)
Time frame: 6 months Follow Up
Vessel stiffness
Vascular stiffness determined through pulse wave velocity (PWV)
Time frame: 6 months Follow Up
Primary patency
determined through doppler ultrasound
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
Plan to share: No
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This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Essen