Status:
UNKNOWN
Safety and Efficacy of Atherectomy on VasculaR Functions
Lead Sponsor:
University Hospital, Essen
Collaborating Sponsors:
Straub Medical AG
Conditions:
Peripheral Arterial Disease
Claudication, Intermittent
Eligibility:
All Genders
18-80 years
Phase:
NA
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04092972
Start Date
January 1 2019
End Date
August 31 2021
Last Update
January 25 2021
Active Locations (1)
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1
University Hospital Essen
Essen, North Rhine-Westphalia, Germany, 45122