Trial Outcomes & Findings for PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia (NCT NCT03970538)

Results Overview

freedom from major amputation and death at 6 months, compared to a historical performance goal.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

105 participants

Primary outcome timeframe

6 months post-procedure

Results posted on

2024-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Overall Study STARTED	105
Overall Study COMPLETED	105
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Age, Continuous	69 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	76 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	23 Participants n=5 Participants
Region of Enrollment United States	105 participants n=5 Participants
Baseline Rutherford Class 5	68 Participants n=5 Participants
Baseline Rutherford Class 6	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post-procedure

freedom from major amputation and death at 6 months, compared to a historical performance goal.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Amputation Free Survival (AFS)	66 Percentage of participants

SECONDARY outcome

Timeframe: 30 days post procedure

Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Primary Patency	68 percentage of participants

SECONDARY outcome

Timeframe: 6 months post-procedure

Absence of occlusion of the endovascular intervention maintained with the use of additional or secondary surgical or endovascular procedures, as long as occlusion of the primary treated site has not occurred.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Primary Assisted Patency	45 Percentage of participants

SECONDARY outcome

Timeframe: 30 days post-procedure

Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical endovascular procedures after occlusion occurs.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Secondary Patency	95 Percentage of participants

SECONDARY outcome

Timeframe: 30 days post-procedure

The percentage of subjects with freedom from above-ankle amputation of the index limb.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Limb Salvage	94 Percentage of participants

SECONDARY outcome

Timeframe: 30 days post-procedure

A decrease in Rutherford class number (i.e.: from Rutherford class 5 to 4) is clinical improvement

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Change in Rutherford Classification	18 Percentage of participants

SECONDARY outcome

Timeframe: Immediately post-procedure

The successful creation of an arteriovenous fistula in the desired limb location with immediate morphological success.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Technical Success	104 Participants

SECONDARY outcome

Timeframe: 30 days post-procedure

Combination of Technical Success, and absence of all-cause death, above-ankle amputation or clinically driven major re-intervention of the stent graft.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Procedure Success	77 Percentage of participants

SECONDARY outcome

Timeframe: 30 days post-procedure

Complete healing of the patient's target wound

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Target Wound Healing	4 Percentage of participants

SECONDARY outcome

Timeframe: 30 days post-procedure

Complete healing of the patient's wounds.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
All Wound Healing	4 Percentage of participants

SECONDARY outcome

Timeframe: Within the first 72 hours post-procedure

Subjects without acute (within 72 hours after intravenous contrast administration) impairment of renal function, measured as an absolute ≥0.5 mg/dL (44 µmol/L) increase compared to baseline SCr value that results in a value above the upper limit of the normal range.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Freedom From Contrast-Induced Nephropathy	103 Participants

SECONDARY outcome

Timeframe: Immediately post-procedure

Time from the first puncture (venous or arterial) to when the last catheter is removed

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Procedure Time	217 minutes Standard Deviation 87.77

SECONDARY outcome

Timeframe: During the procedure

Patient radiation exposure (measured in milligray)

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Radiation Exposure	263 Milligray Standard Deviation 265

SECONDARY outcome

Timeframe: During the procedure

Total volume of contrast media (measured in milliliters)

Outcome measures

Outcome measures
Measure	Treatment n=104 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Contrast Volume	138 milliliter Standard Deviation 80

SECONDARY outcome

Timeframe: 30 days post-procedure

Defined as reduction in area of the patient's wounds

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
All Wound Area Reduction	11 Percentage of participants

SECONDARY outcome

Timeframe: 6 months post procedure

Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Primary Patency	26 Percentage of participants

SECONDARY outcome

Timeframe: 6 months post-procedure

Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical endovascular procedures after occlusion occurs.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Secondary Patency	64 Percentage of participants

SECONDARY outcome

Timeframe: 3 months days post-procedure

The percentage of subjects with freedom from above-ankle amputation of the index limb.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Limb Salvage	85 Percentage of participants

SECONDARY outcome

Timeframe: 6 months days post-procedure

The percentage of subjects with freedom from above-ankle amputation of the index limb.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Limb Salvage	76 Percentage of participants

SECONDARY outcome

Timeframe: 3 months post-procedure

A change of one Rutherford class or greater.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Change in Rutherford Classification	32 Percentage of participants

SECONDARY outcome

Timeframe: 6 months post-procedure

A change of one Rutherford class or greater.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Change in Rutherford Classification	42 Percentage of participants

SECONDARY outcome

Timeframe: 3 months post-procedure

Complete healing of the patient's target wound

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Target Wound Healing	8 Percentage of participants

SECONDARY outcome

Timeframe: 6 months post-procedure

Complete healing of the patient's target wound

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Target Wound Healing	25 Percentage of participants

SECONDARY outcome

Timeframe: 9 months post-procedure

Complete healing of the patient's target wound

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Target Wound Healing	37 Percentage of participants

SECONDARY outcome

Timeframe: 12 months post-procedure

Complete healing of the patient's target wound

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Target Wound Healing	45 Percentage of participants

SECONDARY outcome

Timeframe: 3 months post-procedure

Defined as reduction in area of the patient's wounds

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
All Wound Area Reduction	30 Percentage of participants

SECONDARY outcome

Timeframe: 6 months post-procedure

Defined as reduction in area of the patient's wounds

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
All Wound Area Reduction	41 Percentage of participants

SECONDARY outcome

Timeframe: 9 months post-procedure

Defined as reduction in area of the patient's wounds

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
All Wound Area Reduction	33 Percentage of participants

SECONDARY outcome

Timeframe: 12 months post-procedure

Defined as reduction in area of the patient's wounds

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
All Wound Area Reduction	27 Percentage of participants

SECONDARY outcome

Timeframe: 3 months post-procedure

Complete healing of the patient's wounds.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
All Wound Healing	6 Percentage of participants

SECONDARY outcome

Timeframe: 6 months post-procedure

Complete healing of the patient's wounds.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
All Wound Healing	28 Percentage of participants

SECONDARY outcome

Timeframe: 9 months post-procedure

Complete healing of the patient's wounds.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
All Wound Healing	41 Percentage of participants

SECONDARY outcome

Timeframe: 12 months post-procedure

Complete healing of the patient's wounds.

Outcome measures

Outcome measures
Measure	Treatment n=105 Participants Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
All Wound Healing	42 Percentage of participants

Adverse Events

Treatment

Serious events: 68 serious events

Other events: 98 other events

Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=105 participants at risk Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Gastrointestinal disorders Gastrointestinal Hemorrhage	4.8% 5/105 • Number of events 5 • 6 months
General disorders Incision site impaired healing	5.7% 6/105 • Number of events 6 • 6 months
Infections and infestations Gangrene	9.5% 10/105 • Number of events 10 • 6 months
Infections and infestations Osteomyelitis	6.7% 7/105 • Number of events 7 • 6 months
Infections and infestations Sepsis	5.7% 6/105 • Number of events 6 • 6 months
Infections and infestations Wound Infection	5.7% 6/105 • Number of events 6 • 6 months
Injury, poisoning and procedural complications Wound Complication	5.7% 6/105 • Number of events 6 • 6 months
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 6/105 • Number of events 6 • 6 months
Renal and urinary disorders Acute kidney injury	4.8% 5/105 • Number of events 5 • 6 months
Skin and subcutaneous tissue disorders Debridement	4.8% 5/105 • Number of events 5 • 6 months
Vascular disorders Peripheral ischemia	5.7% 6/105 • Number of events 6 • 6 months

Other adverse events

Other adverse events
Measure	Treatment n=105 participants at risk Treated with the LimFlow System LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Renal and urinary disorders Acute kidney injury	5.7% 6/105 • Number of events 6 • 6 months
Surgical and medical procedures Debridement	5.7% 6/105 • Number of events 6 • 6 months
Vascular disorders Peripheral Ischemia	5.7% 6/105 • Number of events 6 • 6 months
General disorders Impaired healing	6.7% 7/105 • Number of events 7 • 6 months
General disorders Incision site impaired healing	5.7% 6/105 • Number of events 8 • 6 months
Infections and infestations Sepsis	7.6% 8/105 • Number of events 8 • 6 months
General disorders Vascular stent occlusion	8.6% 9/105 • Number of events 9 • 6 months
Musculoskeletal and connective tissue disorders Pain in extremity	8.6% 9/105 • Number of events 9 • 6 months
Surgical and medical procedures Toe amputation	8.6% 9/105 • Number of events 9 • 6 months
Infections and infestations Osteomyelitis	10.5% 11/105 • Number of events 11 • 6 months
Infections and infestations Wound infection	10.5% 11/105 • Number of events 11 • 6 months
Surgical and medical procedures Foot amputation	10.5% 11/105 • Number of events 11 • 6 months
Injury, poisoning and procedural complications Wound complication	10.5% 11/105 • Number of events 12 • 6 months
Infections and infestations Gangrene	11.4% 12/105 • Number of events 15 • 6 months
Vascular disorders Vascular stent occlusion	20.0% 21/105 • Number of events 21 • 6 months

Additional Information

Director, Clinical Affairs

LimFlow

Phone: 559-970-1012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60