PROMISE International

NCT ID: NCT03321552

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-15
• Study Completion Date: 2025-01-23

Brief Summary

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.

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.

Conditions

Critical Limb Ischemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous deep vein arterialization

Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach

Group Type: EXPERIMENTAL

Percutaneous deep vein arterialization

Intervention Type: PROCEDURE

Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach

LimFlow System

Intervention Type: DEVICE

Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach

Interventions

Percutaneous deep vein arterialization

Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach

Intervention Type: PROCEDURE

LimFlow System

Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LimFlow SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinikum Graz

Graz, , Austria

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

SRH Klinikum Karlsbad-Langensteinbach

Karlsbad, Baden-Wurttemberg, Germany

Klinikum Arnsberg GmbH

Arnsberg, North Rhine-Westphalia, Germany

St. Franziskus-Hospital GmbH

Münster, North Rhine-Westphalia, Germany

Universitätsklinikum Leipzig

Leipzig, Saxony, Germany

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Noordwest Ziekenhuisgroep

Alkmaar, , Netherlands

St. Antonius Hospital

Nieuwegein, , Netherlands

Auckland City Hospital

Auckland, , New Zealand

Tan Tock Seng Hospital

Singapore, , Singapore

Changi General Hospital

Singapore, , Singapore

Countries

Austria; Germany; Netherlands; New Zealand; Singapore

References

Schreve MA, Lichtenberg M, Unlu C, Branzan D, Schmidt A, van den Heuvel DAF, Blessing E, Brodmann M, Cabane V, Lin WTQ, Kum S. PROMISE international; a clinical post marketing trial investigating the percutaneous deep vein arterialization (LimFlow) in the treatment of no-option chronic limb ischemia patient. CVIR Endovasc. 2019 Jul 31;2(1):26. doi: 10.1186/s42155-019-0067-z.

Reference Type: BACKGROUND

PMID: 32026120 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EU PMS Revision 4.1

Identifier Type: -

Identifier Source: org_study_id