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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Treated with the LimFlow System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LimFlow System | Device | Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amputation-free Survival | Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality | 30 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Amputation-free Survival | Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality | 6 months post-procedure |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jihad Mustapha, MD | Metro Health, University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Kaiser Permanente |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30819976 | Result | Mustapha JA, Saab FA, Clair D, Schneider P. Interim Results of the PROMISE I Trial to Investigate the LimFlow System of Percutaneous Deep Vein Arterialization for the Treatment of Critical Limb Ischemia. J Invasive Cardiol. 2019 Mar;31(3):57-63. doi: 10.25270/jic/18.00340. | |
| 34019990 | Result | Clair DG, Mustapha JA, Shishehbor MH, Schneider PA, Henao S, Bernardo NN, Deaton DH. PROMISE I: Early feasibility study of the LimFlow System for percutaneous deep vein arterialization in no-option chronic limb-threatening ischemia: 12-month results. J Vasc Surg. 2021 Nov;74(5):1626-1635. doi: 10.1016/j.jvs.2021.04.057. Epub 2021 May 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Amputation-free Survival | Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality | Posted | Number | 95% Confidence Interval | Percentage of participants | 30 days post-procedure |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access Site Bleeding Requiring Transfusion | Injury, poisoning and procedural complications | Other | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access Site Pain or Oozing | Injury, poisoning and procedural complications | Other | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cecilia Petrella | LimFlow Inc. | (888) 478-7705 | 101 | cpetrella@limflow.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2018 | Jan 29, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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Prospective, multi-center pilot study
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| 30 days post-procedure |
| 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. | 6 months post-procedure |
| 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. | 6 months post-procedure |
| Limb Salvage | Percentage of subjects with freedom from above-ankle amputation of the index limb | 12 months post-procedure |
| Wound Healing | Percentage of subjects with full wound healing | 12 months post-procedure |
| 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. | 6 months post-procedure |
| 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. | Post-procedure, immediately |
| 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. | 30 days post-procedure |
| Honolulu |
| Hawaii |
| 96817 |
| United States |
| Metro Health, University of Michigan | Wyoming | Michigan | 49519 | United States |
| New Mexico Heart Institute | Albuquerque | New Mexico | 87102 | United States |
| Mount Sinai Health System | New York | New York | 10029 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Palmetto Health | Columbia | South Carolina | 29203 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Rutherford Class 5 | Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal ischemia. | Count of Participants | Participants |
|
| Baseline Rutherford Class 6 | Major tissue loss - extending above transmetatarsal level, functional foot no longer salvageable | Count of Participants | Participants |
|
|
| Secondary | Amputation-free Survival | Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months post-procedure |
|
|
|
| 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. | Population analyzed was those patients that successfully underwent the index procedure. One patient did not have procedural success resulting in n=31 | Posted | Number | Percentage of participants | 30 days post-procedure |
|
|
|
| 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. | Population analyzed was those patients that successfully underwent the index procedure. One patient did not have procedural success resulting in n=31 | Posted | Number | Percentage of participants | 6 months post-procedure |
|
|
|
| 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. | Population analyzed was those patients that successfully underwent the index procedure. One patient did not have procedural success resulting in n=31 | Posted | Number | Percentage of participants | 6 months post-procedure |
|
|
|
| Secondary | Limb Salvage | Percentage of subjects with freedom from above-ankle amputation of the index limb | Population analyzed was those patients that successfully underwent the index procedure. One patient did not have procedural success resulting in n=31 | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 months post-procedure |
|
|
|
| Secondary | Wound Healing | Percentage of subjects with full wound healing | Population analyzed was those patients that successfully underwent the index procedure. One patient did not have procedural success resulting in n=31 | Posted | Number | Percentage of participants | 12 months post-procedure |
|
|
|
| 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. | Population analyzed was those patients that successfully underwent the index procedure. One patient did not have procedural success resulting in n=31 | Posted | Number | Percentage of participants | 6 months post-procedure |
|
|
|
| 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. | Posted | Number | Percentage of participants | Post-procedure, immediately |
|
|
|
| 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. | Posted | Number | Percentage of participants | 30 days post-procedure |
|
|
|
| 0 |
| 32 |
| 19 |
| 32 |
| 16 |
| 32 |
| Edema | Vascular disorders | Other | Systematic Assessment |
|
| Ischemia, Target Limb (Failed Procedure) | Vascular disorders | Other | Systematic Assessment |
|
| Non-Study Device Balloon Rupture and Embolization Requiring Additional Treatment/Stenting | Injury, poisoning and procedural complications | Other | Systematic Assessment |
|
| Vessel Occlusion/Thrombus Formation | Vascular disorders | Other | Systematic Assessment |
|
| Wound Bleeding or Requiring Debridement | Skin and subcutaneous tissue disorders | Other | Systematic Assessment |
|
| Wound Infection, New or Worsening | Infections and infestations | Other | Systematic Assessment |
|
| Acute Heart Failure | Cardiac disorders | Other | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Other | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | Other | Systematic Assessment |
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| Deterioration in Renal Function | Renal and urinary disorders | Other | Systematic Assessment |
|
| Edema | Vascular disorders | Other | Systematic Assessment |
|
| HyperGlyemia | Endocrine disorders | Other | Systematic Assessment |
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| Hypotension | Cardiac disorders | Other | Systematic Assessment |
|
| Immediate Post Procedure Edema | Vascular disorders | Other | Systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | Other | Systematic Assessment |
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| New Wound on Target Limb | Skin and subcutaneous tissue disorders | Other | Systematic Assessment |
|
| Pain, Target Limg | Vascular disorders | Other | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Other | Systematic Assessment |
|
| Post-Procedure Anemia | Blood and lymphatic system disorders | Other | Systematic Assessment |
|
| Rectal Prolapse | Gastrointestinal disorders | Other | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Other | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | Other | Systematic Assessment |
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| Vessel Occlusion/Thrombus Formation | Vascular disorders | Other | Systematic Assessment |
|
| Vessel Perforation Requiring Treatment (investigational device-related) | Injury, poisoning and procedural complications | Other | Systematic Assessment |
|
| Vessel Stenosis Requiring Reintervention | Vascular disorders | Other | Systematic Assessment |
|
| Wound Bleeding or Requiring Debridement | Skin and subcutaneous tissue disorders | Other | Systematic Assessment |
|
| Wound Infection, New or Worsening | Infections and infestations | Other | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |