Critical Limb IschemiaNCT03321552
PROMISE International
A study testing Percutaneous deep vein arterialization and LimFlow System in people with Critical Limb Ischemia, run by LimFlow SA at 12 sites in 5 countries.
Trial 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 more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Percutaneous deep vein arterialization and LimFlow System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 15 Dec 2017to 23 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Germany5 sites
Klinikum Arnsberg GmbH
Arnsberg, North Rhine-Westphalia, 59755
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
SRH Klinikum Karlsbad-Langensteinbach
Karlsbad, Baden-Wurttemberg, 76307
Universitätsklinikum Leipzig
Leipzig, Saxony, 4103
St. Franziskus-Hospital GmbH
Münster, North Rhine-Westphalia, 48145
Netherlands3 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5200 ME
Noordwest Ziekenhuisgroep
Alkmaar, 1815 JD
St. Antonius Hospital
Nieuwegein, 3430 EM
Singapore2 sites
Tan Tock Seng Hospital
Singapore, 308433
Changi General Hospital
Singapore, 529889
About this study
Official title: 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.
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
- Critical Limb Ischemia
- Being tested
- Percutaneous deep vein arterialization, LimFlow System
- Keywords
- Desert foot, No-option patients, Venous arterialization
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous deep vein arterializationProcedure or surgery
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
LimFlow SystemDevice
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Percutaneous deep vein arterialization; Device: LimFlow System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation-free Survival
Freedom from death or major amputation as calculated using the Kaplan-Meier estimate
Measured: Throughout one year
Secondary outcomes (6)
Wound Healing
Complete index wound healing as assessed by wound pictures
Measured: 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
Measured: Throughout one year
Limb Salvage
Freedom from major amputation as calculated using the Kaplan-Meier estimate
Measured: Throughout one year
Deterioration in Renal Function
Number of participants with deterioration in renal functionas assessed by changes in creatinine level
Measured: 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
Measured: 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
Measured: One month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start15 Dec 2017
- Primary completion23 Jan 2025
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- LimFlow SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321552
- Sponsor's protocol ID
- EU PMS Revision 4.1
- Status last verified
- Dec 2025
- First submitted
- 30 Aug 2017
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
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 at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Deep Vein Arterialization Post-Market Study
- ClinicalTrials.gov ID
- NCT03321552
- Acronym / sponsor ID
- EU PMS Revision 4.1
- Conditions
- Critical Limb Ischemia
- Keywords
- Desert foot, No-option patients, Venous arterialization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- LimFlow SAIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Posted 7 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous deep vein arterialization | Experimental | Procedure: Percutaneous deep vein arterialization, Device: LimFlow SystemCreation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous deep vein arterializationCreation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach | Procedure or surgery | Percutaneous deep vein arterialization |
| LimFlow SystemCreation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach | Device | Percutaneous deep vein arterialization |
Primary outcome
Amputation-free Survival
Time frame: Throughout one year
Freedom from death or major amputation as calculated using the Kaplan-Meier estimate
6 secondary outcomes
Wound Healing
Time frame: Throughout one year
Primary and Secondary Patency as Assessed by Duplex Ultrasound
Time frame: Throughout one year
Limb Salvage
Time frame: Throughout one year
Deterioration in Renal Function
Time frame: One month and six months
Interventions With Technical Success (Procedure Completion)
Time frame: Immediately post-procedure
Interventions With Procedural Success (Technical Success Without Death, Major Amputation, or Re-intervention)
Time frame: One month post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32026120Schreve 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.
- Individual participant dataSharing planned: Undecided. Undecided
Related trials for Critical Limb Ischemia
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-coated Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
RecruitingEarly Phase 1
Nutrition in Patient With Critical Limb Ischemia
Critical Limb Ischemia, Malnutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous deep vein arterialization and LimFlow System in people with Critical Limb Ischemia, run by LimFlow SA at 12 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Netherlands, Singapore, Austria, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation-free Survival (time frame: Throughout one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03321552, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.