Safety and Efficacy of Interventional Treatment Through Atherectomy to Improve Vascular Functions and Patency in Symptomatic Peripheral Artery Disease - Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Treatment-Emerged Adverse Events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Atherectomy
Atherectomy and drug-coated balloon (DCB)
Intervention: Atherectomy (Other)
Standard care
Standard care with predilation (POBA) and DCB
Intervention: POBA and DCB (Other)
Outcomes
Primary Outcomes
Treatment-Emerged Adverse Events
Time Frame: 6 months Follow Up
Incidence of Treatment-Emerged Adverse Events as assessed by angiography and adverse event assessment
Primary patency
Time Frame: 6 months Follow Up
determined through doppler ultrasound
Secondary Outcomes
- Bail-out stent rate(6 months Follow Up)
- Vessel stiffness(6 months Follow Up)
- FMD local(6 months Follow Up)
- target lesion revascularization(6 months Follow Up)
- ABI (Ankle Brachial Index)(6 months Follow Up)
- Systemic endothelial function(6 months Follow Up)
- Change in Plaque burden(during baseline visit)
- Change in plaque characteristic(during baseline visit)
Investigators
Fadi Al-Rashid
MD, Principal Investigator
University Hospital, Essen