PROMISE International

Percutaneous Deep Vein Arterialization Post-Market Study

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: Completed
• 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): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Universitätsklinikum Graz
• Germany
  • Baden-Wurttemberg
    • Heidelberg, Baden-Wurttemberg, Germany, 69120
      • Universitatsklinikum Heidelberg
    • Karlsbad, Baden-Wurttemberg, Germany, 76307
      • SRH Klinikum Karlsbad-Langensteinbach
  • North Rhine-Westphalia
    • Arnsberg, North Rhine-Westphalia, Germany, 59755
      • Klinikum Arnsberg GmbH
    • Münster, North Rhine-Westphalia, Germany, 48145
      • St. Franziskus-Hospital GmbH
  • Saxony
    • Leipzig, Saxony, Germany, 4103
      • Universitatsklinikum Leipzig
• Netherlands
  • 's-Hertogenbosch, Netherlands, 5200 ME
    • Jeroen Bosch ziekenhuis
  • Alkmaar, Netherlands, 1815 JD
    • Noordwest Ziekenhuisgroep
  • Nieuwegein, Netherlands, 3430 EM
    • St. Antonius Hospital
• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital
• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
  • Singapore, Singapore, 529889
    • Changi General Hospital

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 as calculated using the Kaplan-Meier estimate	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 and calculated using the Kaplan-Meier estimate	Throughout one year
Limb Salvage	Freedom from major amputation as calculated using the Kaplan-Meier estimate	Throughout one year
Deterioration in Renal Function	Number of participants with deterioration in renal functionas assessed by changes in creatinine level	One month and six months
Interventions With 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	Immediately post-procedure
Interventions With 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

Collaborators and Investigators

• Sponsor: LimFlow SA

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Actual): January 23, 2025
• Study Completion (Actual): January 23, 2025

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: October 21, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Desert foot; No-option patients; Venous arterialization
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Pathological Conditions, Signs and Symptoms; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: EU PMS Revision 4.1

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