Trial Outcomes & Findings for PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System (NCT NCT03124875)

NCT ID: NCT03124875

Last Updated: 2024-05-21

Results Overview

Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: 30 days post-procedure
• Results posted on: 2024-05-21

Participant Flow

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	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System

Baseline characteristics by cohort

Measure	Treatment n=32 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	70.8 years STANDARD_DEVIATION 13.61 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	11 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants
Baseline Rutherford Class 5	28 Participants n=5 Participants
Baseline Rutherford Class 6	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post-procedure

Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality

Outcome measures

Measure	Treatment n=32 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	90.6 Percentage of participants Interval 73.7 to 96.9

SECONDARY outcome

Timeframe: 6 months post-procedure

Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality

Outcome measures

Measure	Treatment n=32 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	73.8 Percentage of participants Interval 54.4 to 86.0

SECONDARY outcome

Timeframe: 30 days post-procedure

Population: Population analyzed was those patients that successfully underwent the index procedure. One patient did not have procedural success resulting in n=31

Percentage of patients with absence of total occlusion of the stent graft without prior clinically-driven major re-intervention of the stent graft. Total occlusion is defined as absence of flow on color doppler or angiogram and clinically-driven major re-intervention is defined as creation of a new surgical bypass, use of thrombectomy or thrombolysis, or major surgical revision performed for occlusion of the stent graft.

Outcome measures

Measure	Treatment n=31 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	73.2 Percentage of participants

SECONDARY outcome

Timeframe: 6 months post-procedure

Population: Population analyzed was those patients that successfully underwent the index procedure. One patient did not have procedural success resulting in n=31

Percentage of patients with absence of total occlusion of the stent graft without prior clinically-driven major re-intervention of the stent graft.Total occlusion is defined as absence of flow on color doppler or angiogram and clinically-driven major re-intervention is defined as creation of a new surgical bypass, use of thrombectomy or thrombolysis, or major surgical revision performed for occlusion of the stent graft.

Outcome measures

Measure	Treatment n=31 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	29.3 Percentage of participants

SECONDARY outcome

Timeframe: 6 months post-procedure

Population: Population analyzed was those patients that successfully underwent the index procedure. One patient did not have procedural success resulting in n=31

Percentage of patients with absence of total occlusion of the stent graft with or without prior clinically-driven major re-intervention of the stent graft.Total occlusion is defined as absence of flow on color doppler or angiogram and clinically-driven major re-intervention is defined as creation of a new surgical bypass, use of thrombectomy or thrombolysis, or major surgical revision performed for occlusion of the stent graft.

Outcome measures

Measure	Treatment n=31 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	49.5 Percentage of participants

SECONDARY outcome

Timeframe: 12 months post-procedure

Population: Population analyzed was those patients that successfully underwent the index procedure. One patient did not have procedural success resulting in n=31

Percentage of subjects with freedom from above-ankle amputation of the index limb

Outcome measures

Measure	Treatment n=31 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	75.9 Percentage of participants Interval 55.8 to 87.0

SECONDARY outcome

Timeframe: 12 months post-procedure

Population: Population analyzed was those patients that successfully underwent the index procedure. One patient did not have procedural success resulting in n=31

Percentage of subjects with full wound healing

Outcome measures

Measure	Treatment n=31 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.
Wound Healing	58.7 Percentage of participants

SECONDARY outcome

Timeframe: 6 months post-procedure

Population: Population analyzed was those patients that successfully underwent the index procedure. One patient did not have procedural success resulting in n=31

Percentage of subjects with a 25% increase in serum creatinine after using iodine contrast agents, without another clear cause for kidney injury.

Outcome measures

Measure	Treatment n=31 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.
Deterioration in Renal Function	9.4 Percentage of participants

SECONDARY outcome

Timeframe: Post-procedure, immediately

Percentage of subjects with completion of the endovascular procedure 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	Treatment n=32 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	96.9 Percentage of participants

SECONDARY outcome

Timeframe: 30 days post-procedure

Percentage of subjects with a combination of Technical Success and absence of all-cause mortality, above-ankle amputation or clinically driven major re-intervention of the stent graft.

Outcome measures

Measure	Treatment n=32 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.
Procedural Success	77.4 Percentage of participants

Adverse Events

Treatment

Serious events: 19 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=32 participants at risk Treated with the LimFlow Stent Graft System LimFlow Stent Graft System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.
Injury, poisoning and procedural complications Access Site Bleeding Requiring Transfusion	6.2% 2/32 • Number of events 2 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Vascular disorders Edema	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Vascular disorders Ischemia, Target Limb (Failed Procedure)	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Injury, poisoning and procedural complications Non-Study Device Balloon Rupture and Embolization Requiring Additional Treatment/Stenting	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Vascular disorders Vessel Occlusion/Thrombus Formation	21.9% 7/32 • Number of events 7 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Skin and subcutaneous tissue disorders Wound Bleeding or Requiring Debridement	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Infections and infestations Wound Infection, New or Worsening	18.8% 6/32 • Number of events 6 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.

Other adverse events

Measure	Treatment n=32 participants at risk Treated with the LimFlow Stent Graft System LimFlow Stent Graft System: Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.
Injury, poisoning and procedural complications Access Site Pain or Oozing	6.2% 2/32 • Number of events 2 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Cardiac disorders Acute Heart Failure	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Blood and lymphatic system disorders Anemia	9.4% 3/32 • Number of events 3 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Cardiac disorders Arrhythmia	6.2% 2/32 • Number of events 2 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Renal and urinary disorders Deterioration in Renal Function	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Vascular disorders Edema	6.2% 2/32 • Number of events 2 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Endocrine disorders HyperGlyemia	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Cardiac disorders Hypotension	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Vascular disorders Immediate Post Procedure Edema	6.2% 2/32 • Number of events 2 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Psychiatric disorders Mental Status Changes	6.2% 2/32 • Number of events 2 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Skin and subcutaneous tissue disorders New Wound on Target Limb	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Vascular disorders Pain, Target Limg	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Respiratory, thoracic and mediastinal disorders Pneumonia	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Blood and lymphatic system disorders Post-Procedure Anemia	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Gastrointestinal disorders Rectal Prolapse	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Cardiac disorders Tachycardia	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Renal and urinary disorders Urinary Retention	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Vascular disorders Vessel Occlusion/Thrombus Formation	6.2% 2/32 • Number of events 2 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Injury, poisoning and procedural complications Vessel Perforation Requiring Treatment (investigational device-related)	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Vascular disorders Vessel Stenosis Requiring Reintervention	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Skin and subcutaneous tissue disorders Wound Bleeding or Requiring Debridement	3.1% 1/32 • Number of events 1 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.
Infections and infestations Wound Infection, New or Worsening	6.2% 2/32 • Number of events 2 • All-Cause Mortality (as a component of amputation-free survival) assessed up to 6 months. Serious and Other Adverse Events assessed to 30 days. All adverse events were reviewed by an independent Medical Monitor to determine whether an event met the trigger for adjudication by Independent Clinical Events Committee for the following endpoints: all-cause mortality, amputation documented at ankle or above, target limb thrombosis or occlusion, target limb reintervention, or deterioration in renal function.

Additional Information

Cecilia Petrella

LimFlow Inc.

Phone: (888) 478-7705

Email: cpetrella@limflow.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place