PROMISE International

NCT03321552 | Completed Results

• 1 other identifier: EU PMS Revision 4.1
• Study Type: interventional
• Target: 34
• Locations: 5 countries
• Sites: 12

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.

Conditions

Critical Limb Ischemia

Keywords

Desert foot; No-option patients; Venous arterialization

Outcome Measures

Primary Outcomes (1)

• Amputation-free Survival

  Freedom from death or major amputation as calculated using the Kaplan-Meier estimate

  Throughout one year

Secondary Outcomes (6)

• Wound Healing

  Throughout one year

• Primary and Secondary Patency as Assessed by Duplex Ultrasound

  Throughout one year

• Limb Salvage

  Throughout one year

• Deterioration in Renal Function

  One month and six months

• Interventions With Technical Success (Procedure Completion)

  Immediately post-procedure

Study Arms (1)

Percutaneous deep vein arterialization

EXPERIMENTAL

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; Device: LimFlow System

Interventions

LimFlow System DEVICE

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

Percutaneous deep vein arterialization

Percutaneous deep vein arterialization PROCEDURE

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

Percutaneous deep vein arterialization

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• LimFlow SA: lead

Study Sites (12)

Universitätsklinikum Graz

Graz, 8036, Austria

Location

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

SRH Klinikum Karlsbad-Langensteinbach

Karlsbad, Baden-Wurttemberg, 76307, Germany

Location

Klinikum Arnsberg GmbH

Arnsberg, North Rhine-Westphalia, 59755, Germany

Location

St. Franziskus-Hospital GmbH

Münster, North Rhine-Westphalia, 48145, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Saxony, 4103, Germany

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5200 ME, Netherlands

Location

Noordwest Ziekenhuisgroep

Alkmaar, 1815 JD, Netherlands

Location

St. Antonius Hospital

Nieuwegein, 3430 EM, Netherlands

Location

Auckland City Hospital

Auckland, New Zealand

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (1)

• 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.

  PMID: 32026120 BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

PROMISE International was a post-market study of a CE-marked device and consisted of a single study arm due to the extreme nature of the alternative (i.e., major amputation). As such, all data reported are descriptive and are not statistically tested against any comparator.

Results Point of Contact

• Title: Kristi McCaffrey
• Organization: LimFlow SA

kristi.mccaffrey@stryker.com

+1 559 970-1012

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: October 25, 2017
• Study Start: December 15, 2017
• Primary Completion: January 23, 2025
• Study Completion: January 23, 2025
• Last Updated: January 7, 2026
• Results First Posted: January 7, 2026

Record last verified: 2025-12

Locations

AU (1); NZ (1); NL (3); DE (5); SG (2)