Chronic Limb-Threatening Ischemia, Critical Limb Ischemia
Conditions
Keywords
Transcatheter Arterialization of Deep Veins, Percutaneous Deep Vein Arterialization, LimFlow System
Brief summary
This pilot study will investigate the safety, effectiveness and feasibility of the LimFlow Stent Graft System for creating an AV fistula in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach for the treatment of Critical Limb Ischemia (CLI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures.
Detailed description
The PROMISE I Trial was a prospective, multi-center, single-arm, investigational feasibility study assessing the LimFlow System for the treatment of chronic- limb-threatening ischemia by creating an arterio-venous fistula in the below-the-knee vasculature. The study was run under an investigational device exemption (IDE G160156, NCT03124875). Thirty-two subjects were enrolled under protocol revisions A, B, C, and D at seven sites in the United States between 5-July-2017 and 8-April-2019.
Interventions
DEVICELimFlow System
Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.
Sponsors
LimFlow, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multi-center pilot study
Eligibility
Sex/Gender
ALL
Age
21 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of critical limb ischemia with hemodynamic evidence of severely diminished arterial inflow of the index limb and Rutherford Classification 5 r 6 * Reviewed and approved for eligibility by the Investigator and the Independent Safety Committee (ISC)
Exclusion criteria
* Concomitant hepatic or renal insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder * Severe heart failure, recent MI or stroke * Significant peripheral edema or infection that may preclude insertion of a prosthesis or significantly impair wound healing * Known allergies or contraindications to anti platelet therapy or device materials * Immunodeficiency disorder or immunosuppressant therapy * Life expectancy \< 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amputation-free Survival | 30 days post-procedure | Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency | 30 days post-procedure | 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. |
| Secondary Patency | 6 months post-procedure | 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. |
| Limb Salvage | 12 months post-procedure | Percentage of subjects with freedom from above-ankle amputation of the index limb |
| Amputation-free Survival | 6 months post-procedure | Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality |
| Deterioration in Renal Function | 6 months post-procedure | Percentage of subjects with a 25% increase in serum creatinine after using iodine contrast agents, without another clear cause for kidney injury. |
| Technical Success | 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. |
| Procedural Success | 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. |
| Wound Healing | 12 months post-procedure | Percentage of subjects with full wound healing |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 70.8 years STANDARD_DEVIATION 13.61 |
| Baseline Rutherford Class 5 | 28 Participants |
| Baseline Rutherford Class 6 | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 16 / 32 |
| serious Total, serious adverse events | 19 / 32 |
Outcome results
Primary
Amputation-free Survival
Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality
Time frame: 30 days post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Amputation-free Survival | 90.6 Percentage of participants |
Secondary
Amputation-free Survival
Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality
Time frame: 6 months post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Amputation-free Survival | 73.8 Percentage of participants |
Secondary
Deterioration in Renal Function
Percentage of subjects with a 25% increase in serum creatinine after using iodine contrast agents, without another clear cause for kidney injury.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Deterioration in Renal Function | 9.4 Percentage of participants |
Secondary
Limb Salvage
Percentage of subjects with freedom from above-ankle amputation of the index limb
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Limb Salvage | 75.9 Percentage of participants |
Secondary
Primary Patency
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.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Primary Patency | 29.3 Percentage of participants |
Secondary
Primary Patency
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.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Primary Patency | 73.2 Percentage of participants |
Secondary
Procedural Success
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.
Time frame: 30 days post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Procedural Success | 77.4 Percentage of participants |
Secondary
Secondary Patency
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.
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Secondary Patency | 49.5 Percentage of participants |
Secondary
Technical Success
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.
Time frame: Post-procedure, immediately
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Technical Success | 96.9 Percentage of participants |
Secondary
Wound Healing
Percentage of subjects with full wound healing
Time frame: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Wound Healing | 58.7 Percentage of participants |