Safety and Efficacy of Interventional Treatment Through Atherectomy to Improve Vascular Functions and Patency in Symptomatic Peripheral Artery Disease - Pilot Study

University Hospital, Essen1 site in 1 country30 target enrollmentJanuary 1, 2019

ConditionsPeripheral Arterial Disease Claudication, Intermittent

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: University Hospital, Essen
Enrollment: 30
Locations: 1
Primary Endpoint: Treatment-Emerged Adverse Events
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

January 1, 2019

End Date

August 31, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Essen

Responsible Party

Principal Investigator

Fadi Al-Rashid

MD, Principal Investigator

University Hospital, Essen

Eligibility Criteria

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