BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Peripheral Arterial Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Prospective, multi-center 1:1 randomized Study. Patients will be stratified according to a stent-avoiding (study arm) or stent-preferred (control arm) In total 120 patient will be enrolled in this study, each strata will include 60 patients. All enrolled patients will be followed up for 24 month to ...
Prospective, multi-center 1:1 randomized Study. Patients will be stratified according to a stent-avoiding (study arm) or stent-preferred (control arm) In total 120 patient will be enrolled in this study, each strata will include 60 patients. All enrolled patients will be followed up for 24 month to asses the incidence of restenosis by duplex ultrasound and major adverse events. Follow-up visits occur at 6, 12 and 24 month intervals as well as telephone visit after 1,36, 48 and 60 month.
Tracking Information
- NCT #
- NCT03776799
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Dierk Scheinert, Prof. Dr. University Clinic Leipzig
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