Percutaneous Deep Vein Arterialization Post-Market Study (PROMISE UK)

The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.

Study Overview

• Status: Active, not recruiting
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Procedure: Percutaneous deep vein arterialization; Device: LimFlow System

Detailed Description

This study will investigate the safety and effectiveness of the LimFlow System for creating an arterio-venous fistula in the below-the-knee vascular system using an endovascular, minimally invasive approach for the treatment of critical limb ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • North Bristol NHS Trust
  • Leicester, United Kingdom, LE3 9QP
    • Glenfield Hospital
  • Liverpool, United Kingdom, L7 8XP
    • Royal Liverpool and Broadgreen University Hospitals NHS Trust
  • London, United Kingdom, SE1 9RT
    • Guy's and St Thomas' NHS Foundation Trust
  • London, United Kingdom, SW17 0RE
    • St George's University Hospitals NHS Foundation Trust
  • Manchester, United Kingdom, M13 9WL
    • Manchester University NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject must be > 21 and < 95 years of age
• Clinical diagnosis of symptomatic critical limb ischemia, defined as Rutherford category 5 or 6
• Assessment that no conventional surgical or endovascular treatment is possible
• Proximally, the target in-flow artery at the cross-over point must be treatable with a 3.5 - 4.0 mm stent after pre-treatment (by visual estimate), and be <50% stenosed
• Subject is willing and has adequate support to comply with protocol requirements, including medication regimen and follow-up visits

Exclusion Criteria:

• Concomitant hepatic insufficiency, deep venous thrombus in target limb, uncorrected coagulation disorders, or current immunodeficiency disorder
• Prior vein stripping surgery and/or vessel harvesting for CABG in the limb intended for study
• Life expectancy less than 12 months
• Patient currently taking coumarin/warfarin which, in the opinion of the attending physician, interferes with the patient's treatment
• Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal treatment
• Patient currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this treatment
• Patient unable to give consent
• Pregnant or breastfeeding women
• Documented myocardial infarction or stroke within previous 90 days
• Patients suffering from renal insufficiency (GFR value less than 30 ml/min/1.73 m²) who are not on hemodialysis
• Patients with vasculitis and/or untreated popliteal aneurysms
• Patients with acute limb ischemia
• Prior peripheral arterial bypass procedure above or below the knee which could inhibit proximal inflow to the stent graft
• Lower extremity venous disease with significant edema in the target limb that may inhibit the procedure and/or jeopardize wound healing, in the investigator's opinion
• Known or suspected systemic or severe infection (e.g., WIfI foot Infection grade of 3)
• Known or suspected allergies or contraindications to stainless steel, nickel, or contrast agent that cannot be adequately pre-treated, or patients who cannot receive anticoagulation or antiplatelet aggregation therapy
• Severe heart failure, which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure (e.g., known ejection fraction of < 40%, NYHA Classification III-IV)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Percutaneous deep vein arterialization; Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach	Procedure: Percutaneous deep vein arterialization; Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach; Device: LimFlow System; Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amputation-free survival	Freedom from death or major amputation	Throughout one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing	Complete index wound healing as assessed by wound pictures	Throughout one year
Primary and secondary patency as assessed by duplex ultrasound	Stent graft patency as assessed by duplex ultrasound	Throughout one year
Procedural success (technical success without death, major amputation, or re-intervention)	Combination of technical success without death, major amputation, or re-intervention	One month post-procedure
Limb salvage	Freedom from major amputation	Throughout one year
Technical success (procedure completion)	Procedure completion 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, as assessed angiographically	Immediately post-procedure
Quality of Life	Quality of Life, as assessed by the EuroQol EQ-5D questionnaire (https://euroqol.org/)	Throughout one year

Collaborators and Investigators

• Sponsor: LimFlow SA

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2019
• Primary Completion (Actual): October 9, 2023
• Study Completion (Estimated): October 9, 2024

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Desert foot; No-option patients; Venous arterialization
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Atherosclerosis; Peripheral Vascular Diseases; Chronic Disease; Peripheral Arterial Disease; Ischemia; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: EU PMS Revision 4.3-UK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No