Skip to main content
OpenTrials
Completed

NCT Number: NCT03124875

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 ineligible for conventional endovascular or surgical limb salvage procedures.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critical Limb Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

21 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medstar Washington Hospital Center, Washington D.C., District of Columbia, United States

Loading trial locations.

About this study

The PROMISE I Trial was a prospective, multi-center, single-arm, investigational feasibility study assessing the LimFlow System for the treatment of chronic- limb-threatening ischemia by creating an arterio-venous fistula in the below-the-knee vasculature. The study was run under an investigational device exemption (IDE G160156, NCT03124875).

Thirty-two subjects were enrolled under protocol revisions A, B, C, and D at seven sites in the United States between 5-July-2017 and 8-April-2019.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LimFlow System

Device

Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.

Primary outcomes

  1. Amputation-free Survival

    Time frame: 30 days post-procedure

    Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality

Secondary outcomes

  1. Amputation-free Survival

    Time frame: 6 months post-procedure

    Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality

  2. Primary Patency

    Time frame: 30 days post-procedure

    Percentage of patients with absence of total occlusion of the stent graft without prior clinically-driven major re-intervention of the stent graft. Total occlusion is defined as absence of flow on color doppler or angiogram and clinically-driven major re-intervention is defined as creation of a new surgical bypass, use of thrombectomy or thrombolysis, or major surgical revision performed for occlusion of the stent graft.

  3. Primary Patency

    Time frame: 6 months post-procedure

    Percentage of patients with absence of total occlusion of the stent graft without prior clinically-driven major re-intervention of the stent graft.Total occlusion is defined as absence of flow on color doppler or angiogram and clinically-driven major re-intervention is defined as creation of a new surgical bypass, use of thrombectomy or thrombolysis, or major surgical revision performed for occlusion of the stent graft.

  4. Secondary Patency

    Time frame: 6 months post-procedure

    Percentage of patients with absence of total occlusion of the stent graft with or without prior clinically-driven major re-intervention of the stent graft.Total occlusion is defined as absence of flow on color doppler or angiogram and clinically-driven major re-intervention is defined as creation of a new surgical bypass, use of thrombectomy or thrombolysis, or major surgical revision performed for occlusion of the stent graft.

  5. Limb Salvage

    Time frame: 12 months post-procedure

    Percentage of subjects with freedom from above-ankle amputation of the index limb

  6. Wound Healing

    Time frame: 12 months post-procedure

    Percentage of subjects with full wound healing

  7. Deterioration in Renal Function

    Time frame: 6 months post-procedure

    Percentage of subjects with a 25% increase in serum creatinine after using iodine contrast agents, without another clear cause for kidney injury.

  8. Technical Success

    Time frame: Post-procedure, immediately

    Percentage of subjects with completion of the endovascular procedure and immediate morphological success with successful placement of the arterial and venous catheters in the desired location in the limb, and ability to place the stent graft.

  9. Procedural Success

    Time frame: 30 days post-procedure

    Percentage of subjects with a combination of Technical Success and absence of all-cause mortality, above-ankle amputation or clinically driven major re-intervention of the stent graft.

Sponsors and collaborators

Lead sponsor

LimFlow, Inc.

Industry

Registry information

Official study title

Pilot Study to Investigate Safety, Effectiveness and Feasibility of LimFlow Stent Graft System for Creating an AV Fistula for the Treatment of Critical Limb Ischemia

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Apr 24, 2017
Registry last updated
May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.