The PROMISE II Trial, Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
Summary
- Conditions
- Arterial Occlusive Diseases
- Arterial Disease
- Arterial Occlusion
- Chronic Limb-threatening Ischemia
- Critical Limb Ischemia
- Critical Lower Limb Ischemia
- Peripheral Arterial Disease
- Peripheral Artery Disease
- Vascular Diseases
- Peripheral Artery Occlusion
- Peripheral Ischemia
- Peripheral Vascular Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Prospective, multi-center pivotal studyMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 94 years
- Gender
- Both males and females
Description
The objective of this US pivotal trial is to investigate the safety and effectiveness of The LimFlow System for creating an AV connection in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-th...
The objective of this US pivotal trial is to investigate the safety and effectiveness of The LimFlow System for creating an AV connection in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-threatening ischemia (CLTI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures.
Tracking Information
- NCT #
- NCT03970538
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Daniel Clair, MD Prisma Health
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