An interventional study of Percutaneous deep vein arterialization and LimFlow System in Critical Limb Ischemia, sponsored by LimFlow SA. Completed at 6 sites in United Kingdom. Open to participants aged 21 Years to 95 Years. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by LimFlow SA (part of Stryker) · Not applicable, Interventional, and Treatment
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Among 22 studies in Chronic Limb-Threatening Ischemia with a site in United Kingdom — 6 open to participants now, 8 under way, none of them phase 3. Chronic Limb-Threatening Ischemia · United Kingdom.
Among the 22 studies in Chronic Limb-Threatening Ischemia with a site in United Kingdom, this one is the 8th largest by enrollment of the 12 interventional ones that give a count, is one of 5 that started in 2019, is one of 7 with no phase, and was the 8th registered.
357 studies on the registry are indexed under Chronic Limb-Threatening Ischemia; 72 are open to participants now.
Browse Chronic Limb-Threatening Ischemia studies →6 of the 22 studies in Chronic Limb-Threatening Ischemia with a site in United Kingdom are open now. Recruiting first, the newest first:
Cardiovascular and Interventional Radiological Society of Europe · Sites in United Kingdom
Ages 18+
Cardiovascular and Interventional Radiological Society of Europe · Sites in United Kingdom
Ages 18+
University of Edinburgh · Sites in United Kingdom
Ages 18+
University of Leicester · Sites in United Kingdom
Ages 18–110
University of Manchester · Sites in United Kingdom
Ages 18+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 49 Chronic Limb-Threatening Ischemia studies recruiting now, 33 (67%) set no upper age limit and 2 (4%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 21 Years to 95 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 5 started in 2019.
This study's enrollment of 28 is below the median of 41 across 240 interventional studies indexed under Chronic Limb-Threatening Ischemia.
Median enrollment 49 across the 12 interventional studies, 278 across the 10 observational. Of the 14 that completed or were terminated, 4 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 22 have an industry lead sponsor. The 10 most frequent:
This study is registered under LimFlow SA, one of the names counted as Stryker. Under that name alone:
LimFlow SA is the lead sponsor of 2 studies on the registry; none are open to participants now.
Stryker has 6 studies filed under Chronic Limb-Threatening Ischemia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 22 studies in Chronic Limb-Threatening Ischemia with a site in United Kingdom, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Amputation-free Survival
Freedom from death or major amputation
Time frame: Throughout one year
Wound Healing
Complete index wound healing as assessed by wound pictures
Time frame: Throughout one year
Primary and Secondary Patency
Stent graft primary and secondary patency as assessed by duplex ultrasound
Time frame: Throughout one year
Limb Salvage
Freedom from major amputation
Time frame: Throughout one year
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, as assessed angiographically
Time frame: Immediately post-procedure (approximately 4 hours after vascular access)
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
A total of 64 subjects were screened at 6 sites across England, during the time period from 11-Dec-2019 to 26-Oct-2022, yielding 28 subjects enrolled in the study.
| Milestone | ITT Population |
|---|---|
| Started | 28 |
| Completed | 28 |
| Not completed | 0 |
Freedom from death or major amputation
| percentage of participants | Percutaneous Deep Vein Arterialization |
|---|---|
| Amputation-free Survival | 67.2 (46.4 to 81.4) |
Complete index wound healing as assessed by wound pictures
| Participants | Percutaneous Deep Vein Arterialization |
|---|---|
| Wound Healing | 12 |
Stent graft primary and secondary patency as assessed by duplex ultrasound
| percentage of participants | Percutaneous Deep Vein Arterialization |
|---|---|
| Primary patency | 31.7 (13.5 to 51.8) |
| Secondary patency | 43.4 (22.1 to 63.1) |
Freedom from major amputation
| percentage of participants | Percutaneous Deep Vein Arterialization |
|---|---|
| Limb Salvage | 81.2 (60.6 to 91.8) |
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, as assessed angiographically
| Participants | Percutaneous Deep Vein Arterialization |
|---|---|
| Technical Success (Procedure Completion) | 27 |
Combination of technical success without death, major amputation, or re-intervention
| Participants | Percutaneous Deep Vein Arterialization |
|---|---|
| Procedural Success (Technical Success Without Death, Major Amputation, or Re-intervention) | 20 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Percutaneous Deep Vein Arterialization | 4/28 (14.3%) | 26/28 (92.9%) | 19/28 (67.9%) |
| Event | Percutaneous Deep Vein Arterialization |
|---|---|
| Arterial or venous occlusion (target limb)Vascular disorders | 23/28 |
| Wound healing disorderVascular disorders | 6/28 |
| Wound infectionInfections and infestations | 5/28 |
| New wound or ulcerVascular disorders | 4/28 |
| Bleeding (non-target limb)Blood and lymphatic system disorders | 3/28 |
| Gangrene or necrosisVascular disorders | 3/28 |
| Other blood flow abnormality (target limb)Vascular disorders | 3/28 |
| Pain (target limb)Vascular disorders | 3/28 |
| Chest infectionInfections and infestations | 2/28 |
| Heart failureCardiac disorders | 2/28 |
| Event | Percutaneous Deep Vein Arterialization |
|---|---|
| Arterial or venous occlusion (target limb)Vascular disorders | 6/28 |
| COVID-19Infections and infestations | 4/28 |
| Wound infectionInfections and infestations | 4/28 |
| Bleeding (non-target limb)Blood and lymphatic system disorders | 3/28 |
| Chest infectionInfections and infestations | 3/28 |
| EdemaVascular disorders | 3/28 |
| Cardiac rhythm disorderCardiac disorders | 2/28 |
| FallInjury, poisoning and procedural complications | 2/28 |
| Hypoglycemia or hyperglycemiaEndocrine disorders | 2/28 |
| New wound or ulcerVascular disorders | 2/28 |
| Sex: Female, Male(Participants) | Percutaneous Deep Vein Arterialization |
|---|---|
| Female | 3 |
| Male | 25 |
| Race and Ethnicity Not Collected(Participants) | Percutaneous Deep Vein Arterialization |
|---|
| BMI(killograms per squared metre) | Percutaneous Deep Vein Arterialization |
|---|---|
| Mean | 26.1 ± 5.0 |
| Age, Continuous(years) | Percutaneous Deep Vein Arterialization |
|---|---|
| Mean | 66.7 ± 11.2 |
| Current or Former Smoker(Participants) | Percutaneous Deep Vein Arterialization |
|---|---|
| Count of participants | 21 |
| Baseline Diabetes Status(Participants) | Percutaneous Deep Vein Arterialization |
|---|---|
| Count of participants | 23 |
| Hypertension requiring medication(Participants) | Percutaneous Deep Vein Arterialization |
|---|---|
| Count of participants | 21 |
| Hyperlipidaemia req. medication(Participants) | Percutaneous Deep Vein Arterialization |
|---|---|
| Count of participants | 16 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Undecided
Ran from Dec 2019 to primary completion in Oct 2023, 45 months.
Results were first posted in Nov 2025, 2 years 1 month after primary completion.
Of 71 interventional studies with no phase under Chronic Limb-Threatening Ischemia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 85. This study's 45 months is above that.
How these figures are worked out, and which studies are left out of them.
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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Chronic Limb-Threatening Ischemia →