N/A
N=32
PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
Critical Limb Ischemia · Chronic Limb-Threatening Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT03124875 ↗Enrolled (actual)
32
Serious AEs
59.4%
Results posted
May 2024
Primary outcome: Primary: Amputation-free Survival — 90.6 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LimFlow System (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- LimFlow, Inc.
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amputation-free Survival |
73.8 | — |
| SECONDARY Amputation-free Survival |
73.8 | — |
| SECONDARY Primary Patency |
29.3 | — |
| SECONDARY Primary Patency |
29.3 | — |
| SECONDARY Secondary Patency |
49.5 | — |
| SECONDARY Limb Salvage |
75.9 | — |
| SECONDARY Wound Healing |
58.7 | — |
| SECONDARY Deterioration in Renal Function |
9.4 | — |
| SECONDARY Technical Success |
96.9 | — |
| SECONDARY Procedural Success |
77.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of critical limb ischemia with hemodynamic evidence of severely diminished arterial inflow of the index limb and Rutherford Classification 5 r 6
- Reviewed and approved for eligibility by the Investigator and the Independent Safety Committee (ISC)
Exclusion Criteria
- Concomitant hepatic or renal insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder
- Severe heart failure, recent MI or stroke
- Significant peripheral edema or infection that may preclude insertion of a prosthesis or significantly impair wound healing
- Known allergies or contraindications to anti platelet therapy or device materials
- Immunodeficiency disorder or immunosuppressant therapy
- Life expectancy < 12 months
Data sourced from ClinicalTrials.gov (NCT03124875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.