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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03970538
Recruitment Status : Active, not recruiting
First Posted : May 31, 2019
Results First Posted : February 28, 2024
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
LimFlow, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Critical Limb Ischemia
Critical Lower Limb Ischemia
Peripheral Artery Disease
Peripheral Arterial Disease
Chronic Limb-Threatening Ischemia
Arterial Occlusive Diseases
Arterial Occlusion
Arterial Disease
Peripheral Artery Occlusion
Peripheral Vascular Disease
Peripheral Ischemia
Vascular Diseases
Intervention Device: LimFlow System
Enrollment 105
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description

Treated with the LimFlow System

LimFlow System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
Period Title: Overall Study
Started 105
Completed 105
Not Completed 0
Arm/Group Title Treatment Arm
Hide Arm/Group Description

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 Number of Baseline Participants 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants
69  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Female
33
  31.4%
Male
72
  68.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Hispanic or Latino
29
  27.6%
Not Hispanic or Latino
76
  72.4%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
16
  15.2%
White
64
  61.0%
More than one race
0
   0.0%
Unknown or Not Reported
23
  21.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 105 participants
105
Baseline Rutherford Class 5   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
68
  64.8%
[1]
Measure Description: ISCHEMIC ULCERATION (Rutherford class 5)
Baseline Rutherford Class 6   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
37
  35.2%
[1]
Measure Description: ISCHEMIC GANGRENE (Rutherford class 6)
1.Primary Outcome
Title Amputation Free Survival (AFS)
Hide Description freedom from major amputation and death at 6 months, compared to a historical performance goal.
Time Frame 6 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
66
2.Secondary Outcome
Title Primary Patency
Hide Description Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures.
Time Frame 30 days post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: percentage of participants
68
3.Secondary Outcome
Title Primary Assisted Patency
Hide Description 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.
Time Frame 6 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
45
4.Secondary Outcome
Title Secondary Patency
Hide Description Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical endovascular procedures after occlusion occurs.
Time Frame 30 days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
95
5.Secondary Outcome
Title Limb Salvage
Hide Description The percentage of subjects with freedom from above-ankle amputation of the index limb.
Time Frame 30 days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
94
6.Secondary Outcome
Title Change in Rutherford Classification
Hide Description A decrease in Rutherford class number (i.e.: from Rutherford class 5 to 4) is clinical improvement
Time Frame 30 days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
18
7.Secondary Outcome
Title Technical Success
Hide Description The successful creation of an arteriovenous fistula in the desired limb location with immediate morphological success.
Time Frame Immediately post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 105
Measure Type: Count of Participants
Unit of Measure: Participants
104
  99.0%
8.Secondary Outcome
Title Procedure Success
Hide Description Combination of Technical Success, and absence of all-cause death, above-ankle amputation or clinically driven major re-intervention of the stent graft.
Time Frame 30 days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
77
9.Secondary Outcome
Title Target Wound Healing
Hide Description Complete healing of the patient's target wound
Time Frame 30 days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
4
10.Secondary Outcome
Title All Wound Healing
Hide Description Complete healing of the patient's wounds.
Time Frame 30 days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
4
11.Secondary Outcome
Title Freedom From Contrast-Induced Nephropathy
Hide Description 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.
Time Frame Within the first 72 hours post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 105
Measure Type: Count of Participants
Unit of Measure: Participants
103
  98.1%
12.Secondary Outcome
Title Procedure Time
Hide Description Time from the first puncture (venous or arterial) to when the last catheter is removed
Time Frame Immediately post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: minutes
217  (87.77)
13.Secondary Outcome
Title Radiation Exposure
Hide Description Patient radiation exposure (measured in milligray)
Time Frame During the procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 105
Mean (Standard Deviation)
Unit of Measure: Milligray
263  (265)
14.Secondary Outcome
Title Contrast Volume
Hide Description Total volume of contrast media (measured in milliliters)
Time Frame During the procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 104
Mean (Standard Deviation)
Unit of Measure: milliliter
138  (80)
15.Secondary Outcome
Title All Wound Area Reduction
Hide Description Defined as reduction in area of the patient's wounds
Time Frame 30 days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
11
16.Secondary Outcome
Title Primary Patency
Hide Description Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures.
Time Frame 6 months post procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

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 Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
26
17.Secondary Outcome
Title Secondary Patency
Hide Description Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical endovascular procedures after occlusion occurs.
Time Frame 6 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
64
18.Secondary Outcome
Title Limb Salvage
Hide Description The percentage of subjects with freedom from above-ankle amputation of the index limb.
Time Frame 3 months days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
85
19.Secondary Outcome
Title Limb Salvage
Hide Description The percentage of subjects with freedom from above-ankle amputation of the index limb.
Time Frame 6 months days post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
76
20.Secondary Outcome
Title Change in Rutherford Classification
Hide Description A change of one Rutherford class or greater.
Time Frame 3 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
32
21.Secondary Outcome
Title Change in Rutherford Classification
Hide Description A change of one Rutherford class or greater.
Time Frame 6 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
42
22.Secondary Outcome
Title Target Wound Healing
Hide Description Complete healing of the patient's target wound
Time Frame 3 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
8
23.Secondary Outcome
Title Target Wound Healing
Hide Description Complete healing of the patient's target wound
Time Frame 6 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
25
24.Secondary Outcome
Title Target Wound Healing
Hide Description Complete healing of the patient's target wound
Time Frame 9 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
37
25.Secondary Outcome
Title Target Wound Healing
Hide Description Complete healing of the patient's target wound
Time Frame 12 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
45
26.Secondary Outcome
Title All Wound Area Reduction
Hide Description Defined as reduction in area of the patient's wounds
Time Frame 3 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
30
27.Secondary Outcome
Title All Wound Area Reduction
Hide Description Defined as reduction in area of the patient's wounds
Time Frame 6 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
41
28.Secondary Outcome
Title All Wound Area Reduction
Hide Description Defined as reduction in area of the patient's wounds
Time Frame 9 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
33
29.Secondary Outcome
Title All Wound Area Reduction
Hide Description Defined as reduction in area of the patient's wounds
Time Frame 12 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
27
30.Secondary Outcome
Title All Wound Healing
Hide Description Complete healing of the patient's wounds.
Time Frame 3 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
6
31.Secondary Outcome
Title All Wound Healing
Hide Description Complete healing of the patient's wounds.
Time Frame 6 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
28
32.Secondary Outcome
Title All Wound Healing
Hide Description Complete healing of the patient's wounds.
Time Frame 9 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
41
33.Secondary Outcome
Title All Wound Healing
Hide Description Complete healing of the patient's wounds.
Time Frame 12 months post-procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Procedure Time
Hide Arm/Group Description:
treated with the limflow system
Overall Number of Participants Analyzed 105
Measure Type: Number
Unit of Measure: Percentage of participants
42
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description

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-Cause Mortality
Treatment
Affected / at Risk (%)
Total   12/105 (11.43%)    
Hide Serious Adverse Events
Treatment
Affected / at Risk (%) # Events
Total   68/105 (64.76%)    
Gastrointestinal disorders   
Gastrointestinal Hemorrhage † 1  5/105 (4.76%)  5
General disorders   
Incision site impaired healing † 1  6/105 (5.71%)  6
Infections and infestations   
Gangrene † 1  10/105 (9.52%)  10
Osteomyelitis † 1  7/105 (6.67%)  7
Sepsis † 1  6/105 (5.71%)  6
Wound Infection † 1  6/105 (5.71%)  6
Injury, poisoning and procedural complications   
Wound Complication † 1  6/105 (5.71%)  6
Musculoskeletal and connective tissue disorders   
Pain in extremity † 1  6/105 (5.71%)  6
Renal and urinary disorders   
Acute kidney injury † 1  5/105 (4.76%)  5
Skin and subcutaneous tissue disorders   
Debridement † 1  5/105 (4.76%)  5
Vascular disorders   
Peripheral ischemia † 1  6/105 (5.71%)  6
1
Term from vocabulary, MedDRA (Unspecified)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment
Affected / at Risk (%) # Events
Total   98/105 (93.33%)    
General disorders   
Impaired healing † 1  7/105 (6.67%)  7
Incision site impaired healing † 1  6/105 (5.71%)  8
Vascular stent occlusion † 1  9/105 (8.57%)  9
Infections and infestations   
Sepsis † 1  8/105 (7.62%)  8
Osteomyelitis † 1  11/105 (10.48%)  11
Wound infection † 1  11/105 (10.48%)  11
Gangrene † 1  12/105 (11.43%)  15
Injury, poisoning and procedural complications   
Wound complication † 1  11/105 (10.48%)  12
Musculoskeletal and connective tissue disorders   
Pain in extremity † 1  9/105 (8.57%)  9
Renal and urinary disorders   
Acute kidney injury † 1  6/105 (5.71%)  6
Surgical and medical procedures   
Debridement † 1  6/105 (5.71%)  6
Toe amputation † 1  9/105 (8.57%)  9
Foot amputation † 1  11/105 (10.48%)  11
Vascular disorders   
Peripheral Ischemia † 1  6/105 (5.71%)  6
Vascular stent occlusion † 1  21/105 (20.00%)  21
1
Term from vocabulary, MedDRA (Unspecified)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Affairs
Organization: LimFlow
Phone: 559-970-1012
EMail: kmccaffrey@limflow.com
Publications of Results:
Shishehbor MH, Powell RJ, Montero-Baker MF, Dua A, Martinez-Trabal JL, Bunte MC, Lee AC, Mugglin AS, Mills JL, Farber A, Clair DG; PROMISE II Investigators. Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia. N Engl J Med. 2023 Mar 30;388(13):1171-1180. doi: 10.1056/NEJMoa2212754.
Layout table for additonal information
Responsible Party: LimFlow, Inc.
ClinicalTrials.gov Identifier: NCT03970538    
Other Study ID Numbers: LF-CA-PR-3
First Submitted: May 29, 2019
First Posted: May 31, 2019
Results First Submitted: December 20, 2023
Results First Posted: February 28, 2024
Last Update Posted: February 28, 2024