CompletedNCT03321552Updated Jan 7, 2026Results posted

PROMISE International

An interventional study of Percutaneous deep vein arterialization and LimFlow System in Critical Limb Ischemia, sponsored by LimFlow SA. Completed at 12 sites in 5 countries. Open to participants aged 21 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by LimFlow SA · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 34
Allocation: Not applicable
Ages: 21 Years to 95 Years
Sex: All

Study 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.

Read the 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 studied

Critical Limb Ischemia

Browse trials for

Chronic Limb-Threatening Ischemia 342

Keywords

Desert foot
No-option patients
Venous arterialization

Who can participate

Ages eligible: 21 Years to 95 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 34 participants (actual)

Study arms

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 · Device: LimFlow System

Interventions

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

What researchers measure

Primary outcomes

Amputation-free Survival
Freedom from death or major amputation as calculated using the Kaplan-Meier estimate
Time frame: Throughout one year

Secondary outcomes

Wound Healing
Complete index wound healing as assessed by wound pictures
Time frame: 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
Time frame: Throughout one year
Limb Salvage
Freedom from major amputation as calculated using the Kaplan-Meier estimate
Time frame: Throughout one year
Deterioration in Renal Function
Number of participants with deterioration in renal functionas assessed by changes in creatinine level
Time frame: 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
Time frame: 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
Time frame: One month post-procedure

Results

Posted Jan 7, 2026

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.

Participant flow

There were 60 subjects screened at 10 sites in 4 countries resulting in 34 subjects enrolled between December 2017 and January 2022.

Participant flow — Overall Study
Milestone	Percutaneous Deep Vein Arterialization
Started	34
Completed	34
Not completed	0

Outcome measures

PrimaryAmputation-free Survival

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

Time frame:: Throughout one year
Reported as:: Number · percentage of participants

Amputation-free Survival
percentage of participants	Percutaneous Deep Vein Arterialization
Amputation-free Survival	50.7 (32.5 to 66.3)

SecondaryWound Healing

Complete index wound healing as assessed by wound pictures

Time frame:: Throughout one year
Reported as:: Count of units · Legs

Wound Healing
Legs	Percutaneous Deep Vein Arterialization
Wound Healing	10

SecondaryPrimary and Secondary Patency as Assessed by Duplex Ultrasound

Stent graft patency as assessed by duplex ultrasound and calculated using the Kaplan-Meier estimate

Time frame:: Throughout one year
Reported as:: Number · percentage of legs

Primary and Secondary Patency as Assessed by Duplex Ultrasound
percentage of legs	Percutaneous Deep Vein Arterialization
Primary patency	34.0 (14.6 to 54.5)
Secondary patency	67.4 (42.3 to 83.4)

SecondaryLimb Salvage

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

Time frame:: Throughout one year
Reported as:: Number · percentage of legs

Limb Salvage
percentage of legs	Percutaneous Deep Vein Arterialization
Limb Salvage	66.6 (46.7 to 80.6)

SecondaryDeterioration in Renal Function

Number of participants with deterioration in renal functionas assessed by changes in creatinine level

Time frame:: One month and six months
Reported as:: Count of participants · Participants

Deterioration in Renal Function
Participants	Percutaneous Deep Vein Arterialization
Deterioration in renal function at 1 month	0
Deterioration in renal function at 2 months	2

SecondaryInterventions 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

Time frame:: Immediately post-procedure
Reported as:: Count of units · Interventions

Interventions With Technical Success (Procedure Completion)
Interventions	Percutaneous Deep Vein Arterialization
Interventions With Technical Success (Procedure Completion)	33

SecondaryInterventions With Procedural Success (Technical Success Without Death, Major Amputation, or Re-intervention)

Combination of technical success without death, major amputation, or re-intervention

Time frame:: One month post-procedure
Reported as:: Count of participants · Participants

Interventions With Procedural Success (Technical Success Without Death, Major Amputation, or Re-intervention)
Participants	Percutaneous Deep Vein Arterialization
Interventions With Procedural Success (Technical Success Without Death, Major Amputation, or Re-intervention)	24

Adverse events

Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Percutaneous Deep Vein Arterialization	7/34 (20.6%)	32/34 (94.1%)	5/34 (14.7%)

Most frequent serious events

Showing 10 of 26

Most frequent serious events
Event	Percutaneous Deep Vein Arterialization
Arterial or venous occlusion (target limb)Vascular disorders	19/34
Wound infectionInfections and infestations	10/34
Pain (target limb)Vascular disorders	7/34
Wound healing disorderVascular disorders	5/34
Myocardial infarctionVascular disorders	4/34
Gangrene or necrosisVascular disorders	3/34
Sepsis or systemic infectionInfections and infestations	3/34
Cardiac rhythm disorderCardiac disorders	2/34
Renal failureRenal and urinary disorders	2/34
StrokeVascular disorders	2/34

Most frequent other events

Most frequent other events
Event	Percutaneous Deep Vein Arterialization
Arterial or venous occlusion (target limb)Vascular disorders	3/34
Pain (target limb)Vascular disorders	2/34

Baseline characteristics

There were 35 legs treated in 34 subjects enrolled

Age, Continuous
Age, Continuous(years)	Percutaneous Deep Vein Arterialization
Mean	69.7 ± 10.1

Sex: Female, Male
Sex: Female, Male(Participants)	Percutaneous Deep Vein Arterialization
Female	5
Male	29

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Percutaneous Deep Vein Arterialization

Region of Enrollment
Region of Enrollment(participants)	Percutaneous Deep Vein Arterialization
New Zealand	1
Netherlands	9
Singapore	4
Germany	20

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m²)	Percutaneous Deep Vein Arterialization
Mean	25.0 ± 4.4

Current or former smoker
Current or former smoker(Participants)	Percutaneous Deep Vein Arterialization
Count of participants	16

Diabetes
Diabetes(Participants)	Percutaneous Deep Vein Arterialization
Count of participants	22

Hypertension requiring medication
Hypertension requiring medication(Participants)	Percutaneous Deep Vein Arterialization
Count of participants	26

7 further baseline measures are reported on the registry.

Study locations

12 sites

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

References and documents

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. PubMed 32026120 ↗

Study documents

Protocol and statistical analysis plan · Apr 24, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — Undecided

Registry details

Key details

Study ID: NCT03321552
Lead sponsor: LimFlow SA
Responsible party: Sponsor
First posted: Oct 25, 2017
Start date: Dec 15, 2017
Primary completion: Jan 23, 2025
Completion: Jan 23, 2025
Results posted: Jan 7, 2026
Last update: Jan 7, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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