The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 201
Summary
- Conditions
- Critical Limb Ischemia
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Approximately 201 subjects will be randomized in a 2:1 fashion for phase A RCT. Randomizations will be stratified by investigational center and lesion length with 2 subjects receiving the DES BTK for every 1 subject receiving treatment with standard PTA. Approximately 100 additional subjects will be enrolled in non-randomized phase B where the enrolled subjects are treated with the DES BTK.Masking: Single (Outcomes Assessor)Masking Description: A review of the wound assessment data will be completed by an independent reviewer who will be blinded to the randomized therapy.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Phase A: A global, prospective, multicenter, 2:1 randomized trial evaluating the safety and effectiveness of the DES BTK Vascular Stent System compared to standard percutaneous transluminal angioplasty to treat infrapopliteal artery lesions in subjects with critical limb ischemia(CLI). Phase A RCT w...
Phase A: A global, prospective, multicenter, 2:1 randomized trial evaluating the safety and effectiveness of the DES BTK Vascular Stent System compared to standard percutaneous transluminal angioplasty to treat infrapopliteal artery lesions in subjects with critical limb ischemia(CLI). Phase A RCT will begin with one size of the device: 3.5 mm x 80 mm. Phase B: A global, prospective, multicenter, non-randomized trial collecting additional safety and effectiveness data for the DES BTK Vascular Stent System to treat infrapopliteal artery lesions in subjects with CLI. Additional stent sizes will be added to the trial upon regulatory approval. Approximately 201 subjects will be randomized/enrolled to support a 2:1 randomization in the phase A RCT. Assuming the effectiveness endpoint is met in phase A RCT, approximately 100 additional subjects are expected to be enrolled in phase B non-randomized which is structured as a single arm where the enrolled subjects are treated with the DES BTK Vascular Stent System.
Tracking Information
- NCT #
- NCT03551496
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jihad Mustapha, MD Advanced Cardiac & Vascular Centers for Amputation Prevention Principal Investigator: Hendrik van Overhagen, MD HAGA Ziekenhuis (HagaZiekenhuis van Den Haag) Principal Investigator: Patrick Geraghty, MD Washington University School of Medicine Principal Investigator: Masato Nakamura, MD, PhD Toho University Ohashi Medical Center - Division of Cardiovascular Medicine
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