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NCT03124875 · ClinicalTrials.gov registry record · NA
PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
A NA study of Critical Limb Ischemia and Chronic Limb-Threatening Ischemia, sponsored by LimFlow.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
- 7
- Study locations
NCT03124875: Completed NA study of Critical Limb Ischemia and Chronic Limb-Threatening Ischemia, sponsored by LimFlow.
NCT03124875 is a NA study of Critical Limb Ischemia and Chronic Limb-Threatening Ischemia that has completed, run by LimFlow. The registered enrollment target is 32 participants, below the 90-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (64% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03124875, a NA study of Critical Limb Ischemia and Chronic Limb-Threatening Ischemia, has completed, sponsored by LimFlow.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
- 7
- Study locations
Study Summary
This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach for the treatment of Critical Limb Ischemia (CLI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures.
Primary Outcome
Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality
Conditions Studied
Interventions
- DEVICE LimFlow System
Study Locations (7)
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Hawaii
- Kaiser Permanente - Honolulu
Michigan
- Metro Health, University of Michigan - Wyoming
New Mexico
- New Mexico Heart Institute - Albuquerque
New York
- Mount Sinai Health System - New York
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
South Carolina
- Palmetto Health - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2021-01-05 |
| Phase | NA |
What the finished NCT03124875 record still lists
NCT03124875 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 90-participant average among 18 other Critical Limb Ischemia trials with a reported enrollment target (64% lower).
The record links to 2 conditions, with Critical Limb Ischemia appearing as the primary indexed condition, and to 1 intervention - of which LimFlow System is the first listed.
NCT03124875 lists 7 locations in 7 states (District of Columbia, Hawaii, Michigan).
Frequently Asked Questions
What is clinical trial NCT03124875 about?
NCT03124875 is a clinical study titled "PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System". This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach for the treatment of Critical Limb Ischemia (CLI) in subjects inelig...
What is the current status of trial NCT03124875?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2017-07-05. Estimated completion is 2021-01-05.
What conditions does trial NCT03124875 study?
This clinical trial studies the following conditions: Critical Limb Ischemia, Chronic Limb-Threatening Ischemia.
What interventions are being tested in trial NCT03124875?
The interventions under investigation include: LimFlow System (DEVICE).
Who is sponsoring clinical trial NCT03124875?
This trial is sponsored by LimFlow, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03124875 being conducted?
This trial has 7 study locations across District of Columbia, Hawaii, Michigan, New Mexico, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03124875's enrollment target sits among peer trials
32 12th of 18 higher than 7 of 18 other Critical Limb Ischemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Critical Limb Ischemia 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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