Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 260
Summary
- Conditions
- Artery Stenosis
- Peripheral Artery Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 85 years
- Gender
- Both males and females
Description
Multicenter, prospective, randomized study to be conducted in centers in Europe. A total of 260 subjects will be entered into the study and will be randomized on a 1:1 basis to either directional atherectomy and drug coated balloon angioplasty (optional with stentimplantation), and surgical endarter...
Multicenter, prospective, randomized study to be conducted in centers in Europe. A total of 260 subjects will be entered into the study and will be randomized on a 1:1 basis to either directional atherectomy and drug coated balloon angioplasty (optional with stentimplantation), and surgical endarterectomy for treatment in symptomatic (Rutherford-Becker class 2 to 4) common femoral artery disease. All subjects will undergo repeat duplex-ultrasound measurements 6, 12, and 24 months to assess the primary endpoint of Binary Restenosis. Follow-up visits are scheduled 6, 12, and 24 months.
Tracking Information
- NCT #
- NCT02517827
- Collaborators
- Medtronic
- Investigators
- Principal Investigator: Aljoscha Rastan, MD aljoscha.rastan@universitaets-herzzentrum.de
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