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 (part of Stryker) · Not applicable, Interventional, and Treatment
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Among 32 studies in Chronic Limb-Threatening Ischemia with a site in Germany — none open to participants now, 2 under way, none of them phase 3. Chronic Limb-Threatening Ischemia · Germany.
Among the 32 studies in Chronic Limb-Threatening Ischemia with a site in Germany, this one is the 14th largest by enrollment of the 21 interventional ones that give a count, is one of 6 that started in 2017, is one of 10 with no phase, and was the 19th 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 →None of the 32 studies in Chronic Limb-Threatening Ischemia with a site in Germany is open now. The open studies under Chronic Limb-Threatening Ischemia, anywhere →
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.
32 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 5 · Phase 3 5 · Phase 4 1
First in 2005; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 34 is below the median of 41 across 240 interventional studies indexed under Chronic Limb-Threatening Ischemia.
Median enrollment 49 across the 21 interventional studies, 166 across the 11 observational. Of the 22 that completed or were terminated, 3 (14%) have results posted.
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15 of 32 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 32 studies in Chronic Limb-Threatening Ischemia with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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 as calculated using the Kaplan-Meier estimate
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 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
There were 60 subjects screened at 10 sites in 4 countries resulting in 34 subjects enrolled between December 2017 and January 2022.
| Milestone | Percutaneous Deep Vein Arterialization |
|---|---|
| Started | 34 |
| Completed | 34 |
| Not completed | 0 |
Freedom from death or major amputation as calculated using the Kaplan-Meier estimate
| percentage of participants | Percutaneous Deep Vein Arterialization |
|---|---|
| Amputation-free Survival | 50.7 (32.5 to 66.3) |
Complete index wound healing as assessed by wound pictures
| Legs | Percutaneous Deep Vein Arterialization |
|---|---|
| Wound Healing | 10 |
Stent graft patency as assessed by duplex ultrasound and calculated using the Kaplan-Meier estimate
| 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) |
Freedom from major amputation as calculated using the Kaplan-Meier estimate
| percentage of legs | Percutaneous Deep Vein Arterialization |
|---|---|
| Limb Salvage | 66.6 (46.7 to 80.6) |
Number of participants with deterioration in renal functionas assessed by changes in creatinine level
| Participants | Percutaneous Deep Vein Arterialization |
|---|---|
| Deterioration in renal function at 1 month | 0 |
| Deterioration in renal function at 2 months | 2 |
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
| Interventions | Percutaneous Deep Vein Arterialization |
|---|---|
| Interventions With Technical Success (Procedure Completion) | 33 |
Combination of 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 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Percutaneous Deep Vein Arterialization | 7/34 (20.6%) | 32/34 (94.1%) | 5/34 (14.7%) |
| 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 |
| Event | Percutaneous Deep Vein Arterialization |
|---|---|
| Arterial or venous occlusion (target limb)Vascular disorders | 3/34 |
| Pain (target limb)Vascular disorders | 2/34 |
There were 35 legs treated in 34 subjects enrolled
| Age, Continuous(years) | Percutaneous Deep Vein Arterialization |
|---|---|
| Mean | 69.7 ± 10.1 |
| Sex: Female, Male(Participants) | Percutaneous Deep Vein Arterialization |
|---|---|
| Female | 5 |
| Male | 29 |
| Race and Ethnicity Not Collected(Participants) | Percutaneous Deep Vein Arterialization |
|---|
| Region of Enrollment(participants) | Percutaneous Deep Vein Arterialization |
|---|---|
| New Zealand | 1 |
| Netherlands | 9 |
| Singapore | 4 |
| Germany | 20 |
| Body Mass Index (BMI)(kg/m²) | Percutaneous Deep Vein Arterialization |
|---|---|
| Mean | 25.0 ± 4.4 |
| Current or former smoker(Participants) | Percutaneous Deep Vein Arterialization |
|---|---|
| Count of participants | 16 |
| Diabetes(Participants) | Percutaneous Deep Vein Arterialization |
|---|---|
| Count of participants | 22 |
| Hypertension requiring medication(Participants) | Percutaneous Deep Vein Arterialization |
|---|---|
| Count of participants | 26 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Undecided
Ran from Dec 2017 to primary completion in Jan 2025, 85 months.
Results were first posted in Jan 2026, 11 months 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 85 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 →