Critical Limb IschemiaNCT03124875
PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System
A study testing LimFlow System in people with Critical Limb Ischemia and Chronic Limb-Threatening Ischemia, run by LimFlow, Inc. at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
- What is being tested?
- LimFlow System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 7 sitesUnited States
- Study dates
- 5 Jul 2017to 5 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Palmetto Health
Columbia, South Carolina, 29203
Kaiser Permanente
Honolulu, Hawaii, 96817
Mount Sinai Health System
New York, New York, 10029
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Metro Health, University of Michigan
Wyoming, Michigan, 49519
About this study
Official title: Pilot Study to Investigate Safety, Effectiveness and Feasibility of LimFlow Stent Graft System for Creating an AV Fistula for the Treatment of Critical Limb Ischemia
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.
Read the 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.
- Being tested
- LimFlow System
- Keywords
- Transcatheter Arterialization of Deep Veins, Percutaneous Deep Vein Arterialization, LimFlow System
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LimFlow SystemDevice
Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treated with the LimFlow System Receives: Device: LimFlow System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation-free Survival
Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality
Measured: 30 days post-procedure
Secondary outcomes (9)
Amputation-free Survival
Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months post-procedure
Limb Salvage
Percentage of subjects with freedom from above-ankle amputation of the index limb
Measured: 12 months post-procedure
Wound Healing
Percentage of subjects with full wound healing
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start5 Jul 2017
- Primary completion8 Aug 2019
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multi-center pilot study
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- LimFlow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jihad Mustapha, MD, Principal investigator, Metro Health, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124875
- Sponsor's protocol ID
- ECO-02527-009
- Status last verified
- May 2024
- First submitted
- 14 Apr 2017
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30819976Clair 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.
PubMed 34019990
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate Safety, Effectiveness and Feasibility of LimFlow Stent Graft System for Creating an AV Fistula for the Treatment of Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT03124875
- Acronym / sponsor ID
- ECO-02527-009
- Keywords
- Transcatheter Arterialization of Deep Veins, Percutaneous Deep Vein Arterialization, LimFlow System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- LimFlow, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Posted 21 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-center pilot study
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: LimFlow SystemTreated with the LimFlow System |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LimFlow SystemCreation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia. | Device | Treatment |
Primary outcome
Amputation-free Survival
Time frame: 30 days post-procedure
Percentage of subjects with freedom from above-ankle amputation of the index limb and freedom from all-cause mortality
9 secondary outcomes
Amputation-free Survival
Time frame: 6 months post-procedure
Primary Patency
Time frame: 30 days post-procedure
Primary Patency
Time frame: 6 months post-procedure
Secondary Patency
Time frame: 6 months post-procedure
Limb Salvage
Time frame: 12 months post-procedure
Wound Healing
Time frame: 12 months post-procedure
Deterioration in Renal Function
Time frame: 6 months post-procedure
Technical Success
Time frame: Post-procedure, immediately
Procedural Success
Time frame: 30 days post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30819976Mustapha 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.
- Results publication: PubMed 34019990Clair 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jihad Mustapha, MD principal investigator
Metro Health, University of Michigan
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LimFlow System in people with Critical Limb Ischemia and Chronic Limb-Threatening Ischemia, run by LimFlow, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation-free Survival (time frame: 30 days post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03124875, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.