Trial Outcomes & Findings for Percutaneous Deep Vein Arterialization Post-Market Study (NCT NCT03807661)
NCT ID: NCT03807661
Last Updated: 2026-01-16
Results Overview
Freedom from death or major amputation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Throughout one year
Results posted on
2026-01-16
Participant Flow
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.
Subjects were screened by site personnel and once it was deemed they met clinical inclusion and exclusion criteria, consent was obtained and angiographic and ultrasound imaging of the target arterial and venous anatomy were uploaded for review by an independent review committee. The subject was thereafter screened for suitability as an angiographically-confirmed "no option" patient who had no capacity for treatment with standard endovascular treatment or surgical bypass.
Participant milestones
| Measure |
ITT Population
All subjects successfully screened and enrolled in the study with treatment or attempted treatment with the LimFlow System.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Percutaneous Deep Vein Arterialization
n=28 Participants
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Sex: Female, Male
Female
|
3 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=28 Participants
|
|
BMI
|
26.1 killograms per squared metre
STANDARD_DEVIATION 5.0 • n=28 Participants
|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 11.2 • n=28 Participants
|
|
Current or Former Smoker
|
21 Participants
n=27 Participants • Smoking history unknown in 1 subject
|
|
Baseline Diabetes Status
|
23 Participants
n=28 Participants
|
|
Hypertension requiring medication
|
21 Participants
n=28 Participants
|
|
Hyperlipidaemia req. medication
|
16 Participants
n=28 Participants
|
|
Renal insufficiency
Any Renal Insufficiency
|
5 Participants
n=28 Participants
|
|
Renal insufficiency
Renal Insufficiency Requiring Dialysis
|
3 Participants
n=28 Participants
|
|
Heart Failure
|
7 Participants
n=28 Participants
|
|
Prior intervention to target limb
|
26 Participants
n=28 Participants
|
|
Rutherford classification
Rutherford Class 5
|
26 Participants
n=28 Participants
|
|
Rutherford classification
Rutherford Class 6
|
2 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: Throughout one yearFreedom from death or major amputation
Outcome measures
| Measure |
Percutaneous Deep Vein Arterialization
n=28 Participants
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Amputation-free Survival
|
67.2 percentage of participants
Interval 46.4 to 81.4
|
SECONDARY outcome
Timeframe: Throughout one yearComplete index wound healing as assessed by wound pictures
Outcome measures
| Measure |
Percutaneous Deep Vein Arterialization
n=17 Participants
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Wound Healing
|
12 Participants
|
SECONDARY outcome
Timeframe: Throughout one yearStent graft primary and secondary patency as assessed by duplex ultrasound
Outcome measures
| Measure |
Percutaneous Deep Vein Arterialization
n=27 Participants
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Primary and Secondary Patency
Primary patency
|
31.7 percentage of participants
Interval 13.5 to 51.8
|
|
Primary and Secondary Patency
Secondary patency
|
43.4 percentage of participants
Interval 22.1 to 63.1
|
SECONDARY outcome
Timeframe: Throughout one yearFreedom from major amputation
Outcome measures
| Measure |
Percutaneous Deep Vein Arterialization
n=28 Participants
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Limb Salvage
|
81.2 percentage of participants
Interval 60.6 to 91.8
|
SECONDARY outcome
Timeframe: Immediately post-procedure (approximately 4 hours after vascular access)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
Outcome measures
| Measure |
Percutaneous Deep Vein Arterialization
n=28 Participants
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Technical Success (Procedure Completion)
|
27 Participants
|
SECONDARY outcome
Timeframe: One month post-procedureCombination of technical success without death, major amputation, or re-intervention
Outcome measures
| Measure |
Percutaneous Deep Vein Arterialization
n=28 Participants
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Procedural Success (Technical Success Without Death, Major Amputation, or Re-intervention)
|
20 Participants
|
Adverse Events
Percutaneous Deep Vein Arterialization
Serious events: 26 serious events
Other events: 19 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Percutaneous Deep Vein Arterialization
n=28 participants at risk
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Renal and urinary disorders
Haematuria
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Endocrine disorders
Hypoglycemia or hyperglycemia
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Cardiac disorders
Mitral valve regurgitation
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Vascular disorders
Myocardial infarction
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain (non-target limb)
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pulmonary hypertension
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal failure
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Anemia
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac rhythm disorder
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Delirium
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Dysphagia
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Vascular disorders
Edema
|
3.6%
1/28 • Number of events 1 • 1 year
|
|
Vascular disorders
Arterial or venous occlusion (target limb)
|
82.1%
23/28 • Number of events 44 • 1 year
|
|
Vascular disorders
Wound healing disorder
|
21.4%
6/28 • Number of events 7 • 1 year
|
|
Infections and infestations
Wound infection
|
17.9%
5/28 • Number of events 5 • 1 year
|
|
Vascular disorders
New wound or ulcer
|
14.3%
4/28 • Number of events 4 • 1 year
|
|
Blood and lymphatic system disorders
Bleeding (non-target limb)
|
10.7%
3/28 • Number of events 3 • 1 year
|
|
Vascular disorders
Gangrene or necrosis
|
10.7%
3/28 • Number of events 3 • 1 year
|
|
Vascular disorders
Other blood flow abnormality (target limb)
|
10.7%
3/28 • Number of events 3 • 1 year
|
|
Vascular disorders
Pain (target limb)
|
10.7%
3/28 • Number of events 3 • 1 year
|
|
Infections and infestations
Chest infection
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Cardiac disorders
Heart failure
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Cardiac disorders
Hypotension
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Infections and infestations
Sepsis or systemic infection
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Access site bleeding or hematoma
|
3.6%
1/28 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Percutaneous Deep Vein Arterialization
n=28 participants at risk
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Vascular disorders
Arterial or venous occlusion (target limb)
|
21.4%
6/28 • Number of events 6 • 1 year
|
|
Infections and infestations
COVID-19
|
14.3%
4/28 • Number of events 4 • 1 year
|
|
Infections and infestations
Wound infection
|
14.3%
4/28 • Number of events 4 • 1 year
|
|
Blood and lymphatic system disorders
Bleeding (non-target limb)
|
10.7%
3/28 • Number of events 4 • 1 year
|
|
Infections and infestations
Chest infection
|
10.7%
3/28 • Number of events 3 • 1 year
|
|
Vascular disorders
Edema
|
10.7%
3/28 • Number of events 3 • 1 year
|
|
Cardiac disorders
Cardiac rhythm disorder
|
7.1%
2/28 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Endocrine disorders
Hypoglycemia or hyperglycemia
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Vascular disorders
New wound or ulcer
|
7.1%
2/28 • Number of events 2 • 1 year
|
|
Vascular disorders
Pain (target limb)
|
7.1%
2/28 • Number of events 2 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place