Safety and Efficacy of Atherectomy on VasculaR Functions

Not Applicable

• Conditions: Claudication, Intermittent; Peripheral Arterial Disease
• Interventions: Other: POBA and DCB; Other: Atherectomy

• Registration Number: NCT04092972
• Lead Sponsor: University Hospital, Essen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-09-15
• Study First Posted: 2019-09-17
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-25
• Primary Completion: 2021-07-28
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	POBA and DCB	Standard care with predilation (POBA) and DCB
Atherectomy	Atherectomy	Atherectomy and drug-coated balloon (DCB)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Bail-out stent rate	6 months Follow Up	success of atherectomy in the SFA including the bail-out stenting rates
Vessel stiffness	6 months Follow Up	Vascular stiffness determined through pulse wave velocity (PWV)
FMD local	6 months Follow Up	Local endothelial function and vasomotion testing as determinded by FMD of the femoral artery
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)

Trial Locations

Locations (1)

University Hospital Essen; 🇩🇪 Essen, NRW, Germany