Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia
NCT05313165 · View on ClinicalTrials.gov ↗
Study Summary
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05313165
The ClinicalTrials.gov registry entry for NCT05313165 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LimFlow, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05313165 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05313165?
The interventions under investigation include: LimFlow Stent Graft System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05313165?
This trial is sponsored by LimFlow, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.