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NCT05313165 · ClinicalTrials.gov registry record · NA
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
A NA study of Peripheral Arterial Disease and Critical Limb Ischemia, sponsored by LimFlow.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT05313165: Recruiting NA study of Peripheral Arterial Disease and Critical Limb Ischemia, sponsored by LimFlow.
NCT05313165 is a NA study of Peripheral Arterial Disease and Critical Limb Ischemia that is actively recruiting participants, run by LimFlow. The registered enrollment target is 100 participants, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05313165, a NA study of Peripheral Arterial Disease and Critical Limb Ischemia, is actively recruiting participants, sponsored by LimFlow.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
Primary Outcome
Freedom from major (above-ankle) amputation and death (all-cause mortality)
Conditions Studied
Interventions
- DEVICE LimFlow Stent Graft System
Study Locations (20)
California
- University of California, San Diego Health - La Jolla
- Stanford University School of Medicine - Palo Alto
- UCSF - San Francisco
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center - Torrance
Florida
- The Cardiac and Vascular Institute - Gainesville
- University of Florida - Gainesville
- Tallahassee Research Institute - Tallahassee
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Medical Center - Boston
- UMass Chan Medical School - Worcester
New York
- Northwell Health Long Island Jewish Medical Center - Lake Success
- NYU Langone Health - New York
- Mount Sinai - New York
New Jersey
- Vascular Institute of Atlantic Medical Imaging - Pomona
- Holy Name Medical Center - Teaneck
Connecticut
- Yale University - New Haven
Illinois
- Rush University Medical Center - Chicago
Missouri
- Washington University / Barnes Jewish - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-12-22 |
| Est. Completion | 2027-05-01 |
| Phase | NA |
What NCT05313165 shows while recruiting
NCT05313165 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 4,205-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 1 intervention - of which LimFlow Stent Graft System is the first listed.
NCT05313165 names 20 study sites across 10 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05313165 about?
NCT05313165 is a clinical study titled "PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia". A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
What is the current status of trial NCT05313165?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2022-12-22. Estimated completion is 2027-05-01.
What conditions does trial NCT05313165 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease, Critical Limb Ischemia, Chronic Limb-Threatening Ischemia.
What interventions are being tested in trial NCT05313165?
The interventions under investigation include: LimFlow Stent Graft System (DEVICE).
Who is sponsoring clinical trial NCT05313165?
This trial is sponsored by LimFlow, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05313165 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05313165's enrollment target sits among peer trials
100 39th of 79 higher than 40 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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