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PROMISE International | Clinical Trials | Clareo Health

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PROMISE International

Percutaneous Deep Vein Arterialization Post-Market Study

NCT03321552•LimFlow SA

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.

Eligibility

Age

21 - 95 years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (12)

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

Key Dates

Start Date

December 15, 2017

Primary Completion Date

January 23, 2025

Completion Date

January 23, 2025

Last Updated

January 7, 2026

Enrollment

ACTUAL participants

Conditions

Critical Limb Ischemia

Interventions

Percutaneous deep vein arterialization

PROCEDURE

LimFlow System

DEVICE

Nutrition in Patient With Critical Limb Ischemia

NCT03529019

Critical Limb IschemiaMalnutrition+1 more

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RECRUITINGPHASE4

Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease

NCT05854615

Critical Limb IschemiaBuerger's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

PROMISE International

Inclusion Criteria

Exclusion Criteria

Nutrition in Patient With Critical Limb Ischemia

Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease

Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention

miRNAs in Critical Limb Ischemia (miRNACLI)

MOTIV BTK Randomized Controlled Trial

Additional Hyperbaric Oxygen After Lower Extremity Amputation