Trial Outcomes & Findings for PROMISE International (NCT NCT03321552)
NCT ID: NCT03321552
Last Updated: 2026-01-07
Results Overview
Freedom from death or major amputation as calculated using the Kaplan-Meier estimate
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
Throughout one year
Results posted on
2026-01-07
Participant Flow
There were 60 subjects screened at 10 sites in 4 countries resulting in 34 subjects enrolled between December 2017 and January 2022.
Subjects were screened by site personnel and once it was deemed they met inclusion and exclusion criteria, consent was obtained and imaging of the target arterial and venous anatomy were uploaded for review by an independent review committee to confirm that the patients were "no-option", i.e., with no capacity for standard endovascular or surgical treatment.
Participant milestones
| Measure |
Percutaneous Deep Vein Arterialization
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Percutaneous deep vein arterialization: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
LimFlow System: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Collected for 32 subjects only
Baseline characteristics by cohort
| Measure |
Percutaneous Deep Vein Arterialization
n=35 Legs
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Percutaneous deep vein arterialization: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
LimFlow System: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 10.1 • n=34 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=34 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=34 Participants
|
|
Region of Enrollment
Netherlands
|
9 participants
n=34 Participants
|
|
Region of Enrollment
Singapore
|
4 participants
n=34 Participants
|
|
Region of Enrollment
Germany
|
20 participants
n=34 Participants
|
|
Body Mass Index (BMI)
|
25.0 kg/m²
STANDARD_DEVIATION 4.4 • n=32 Participants • Collected for 32 subjects only
|
|
Current or former smoker
|
16 Participants
n=28 Participants • Smoking history unknown in 6 subjects
|
|
Diabetes
|
22 Participants
n=34 Participants
|
|
Hypertension requiring medication
|
26 Participants
n=33 Participants • Medical history characteristic unknown for 1 subject
|
|
Hyperlipidaemia requiring medication
|
23 Participants
n=33 Participants • Medical history characteristic unknown for 1 subject
|
|
Renal insufficiency
Any renal insufficiency
|
11 Participants
n=34 Participants
|
|
Renal insufficiency
Renal insufficiency requiring dialysis
|
6 Participants
n=34 Participants
|
|
Heart failure
|
18 Participants
n=34 Participants
|
|
Prior Myocardial Infarction (MI)
|
10 Participants
n=34 Participants
|
|
Prior stroke
|
6 Participants
n=34 Participants
|
|
Prior intervention to target limb
|
31 Legs
n=35 Legs
|
|
Rutherford classification
Rutherford Class 5
|
31 Legs
n=35 Legs
|
|
Rutherford classification
Rutherford Class 6
|
4 Legs
n=35 Legs
|
PRIMARY outcome
Timeframe: Throughout one yearFreedom from death or major amputation as calculated using the Kaplan-Meier estimate
Outcome measures
| Measure |
Percutaneous Deep Vein Arterialization
n=34 Participants
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Percutaneous deep vein arterialization: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
LimFlow System: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Amputation-free Survival
|
50.7 percentage of participants
Interval 32.5 to 66.3
|
SECONDARY outcome
Timeframe: Throughout one yearComplete index wound healing as assessed by wound pictures
Outcome measures
| Measure |
Percutaneous Deep Vein Arterialization
n=14 Legs
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Percutaneous deep vein arterialization: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
LimFlow System: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Wound Healing
|
10 Legs
|
SECONDARY outcome
Timeframe: Throughout one yearStent graft patency as assessed by duplex ultrasound and calculated using the Kaplan-Meier estimate
Outcome measures
| Measure |
Percutaneous Deep Vein Arterialization
n=33 Legs
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Percutaneous deep vein arterialization: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
LimFlow System: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Primary and Secondary Patency as Assessed by Duplex Ultrasound
Primary patency
|
34.0 percentage of legs
Interval 14.6 to 54.5
|
|
Primary and Secondary Patency as Assessed by Duplex Ultrasound
Secondary patency
|
67.4 percentage of legs
Interval 42.3 to 83.4
|
SECONDARY outcome
Timeframe: Throughout one yearFreedom from major amputation as calculated using the Kaplan-Meier estimate
Outcome measures
| Measure |
Percutaneous Deep Vein Arterialization
n=35 Legs
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Percutaneous deep vein arterialization: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
LimFlow System: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Limb Salvage
|
66.6 percentage of legs
Interval 46.7 to 80.6
|
SECONDARY outcome
Timeframe: One month and six monthsNumber of participants with deterioration in renal functionas assessed by changes in creatinine level
Outcome measures
| Measure |
Percutaneous Deep Vein Arterialization
n=34 Participants
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Percutaneous deep vein arterialization: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
LimFlow System: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Deterioration in Renal Function
Deterioration in renal function at 1 month
|
0 Participants
|
|
Deterioration in Renal Function
Deterioration in renal function at 2 months
|
2 Participants
|
SECONDARY outcome
Timeframe: Immediately post-procedureProcedure 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
Outcome measures
| Measure |
Percutaneous Deep Vein Arterialization
n=35 Interventions
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Percutaneous deep vein arterialization: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
LimFlow System: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Interventions With Technical Success (Procedure Completion)
|
33 Interventions
|
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=34 Participants
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Percutaneous deep vein arterialization: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
LimFlow System: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
|
|---|---|
|
Interventions With Procedural Success (Technical Success Without Death, Major Amputation, or Re-intervention)
|
24 Participants
|
Adverse Events
Percutaneous Deep Vein Arterialization
Serious events: 32 serious events
Other events: 5 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Percutaneous Deep Vein Arterialization
n=34 participants at risk
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Percutaneous deep vein arterialization: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
LimFlow System: 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)
|
55.9%
19/34 • Number of events 28 • 1 year
|
|
Infections and infestations
Wound infection
|
29.4%
10/34 • Number of events 14 • 1 year
|
|
Vascular disorders
Pain (target limb)
|
20.6%
7/34 • Number of events 9 • 1 year
|
|
Vascular disorders
Wound healing disorder
|
14.7%
5/34 • Number of events 6 • 1 year
|
|
Vascular disorders
Myocardial infarction
|
11.8%
4/34 • Number of events 4 • 1 year
|
|
Vascular disorders
Gangrene or necrosis
|
8.8%
3/34 • Number of events 3 • 1 year
|
|
Infections and infestations
Sepsis or systemic infection
|
8.8%
3/34 • Number of events 3 • 1 year
|
|
Cardiac disorders
Cardiac rhythm disorder
|
5.9%
2/34 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Renal failure
|
5.9%
2/34 • Number of events 2 • 1 year
|
|
Vascular disorders
Stroke
|
5.9%
2/34 • Number of events 2 • 1 year
|
|
Infections and infestations
Chest infection
|
2.9%
1/34 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Access site bleeding or hematoma
|
2.9%
1/34 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Delirium
|
2.9%
1/34 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
1/34 • Number of events 1 • 1 year
|
|
Cardiac disorders
Heart failure
|
2.9%
1/34 • Number of events 1 • 1 year
|
|
Endocrine disorders
Hypoglycemia or hyperglycemia
|
2.9%
1/34 • Number of events 1 • 1 year
|
|
Vascular disorders
New wound or ulcer
|
2.9%
1/34 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain (non-target limb)
|
2.9%
1/34 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Acute liver failure
|
2.9%
1/34 • Number of events 1 • 1 year
|
|
Vascular disorders
Bowel ischemia
|
2.9%
1/34 • Number of events 1 • 1 year
|
|
Vascular disorders
Erythema and tenderness
|
2.9%
1/34 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.9%
1/34 • Number of events 1 • 1 year
|
|
Vascular disorders
Pulmonary embolism
|
2.9%
1/34 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.9%
1/34 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
2.9%
1/34 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Spinal spondylosis
|
2.9%
1/34 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Percutaneous Deep Vein Arterialization
n=34 participants at risk
Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
Percutaneous deep vein arterialization: Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
LimFlow System: 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)
|
8.8%
3/34 • Number of events 3 • 1 year
|
|
Vascular disorders
Pain (target limb)
|
5.9%
2/34 • Number of events 2 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place