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

Peripheral Arterial Disease Clinical Trial

Official title:

Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: The PROMISE III Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05313165
• Other study ID #: LF-CA-PR-53
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2022
• Est. completion date: May 1, 2027

Study information

• Verified date: February 2024
• Source: LimFlow, Inc.
• Contact: Erin Towery
• Phone: 888-478-7705
• Email: etowery[@]limflow.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System.

Description:

The objective of this study is to provide additional information on the LimFlow System for creating an AV connection in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-threatening ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

1. Subject must be = 18 and = 95 years of age

2. Clinical diagnosis of chronic limb-threatening ischemia, defined as any of the following clinical assessments: previous angiogram or hemodynamic evidence of severely diminished arterial inflow of the index limb (e.g., ABI = 0.39, TP / TcPO2 < 30 mm Hg) and

1. Rutherford Classification 5, ischemic ulceration or

2. Rutherford Classification 6, ischemic gangrene

3. Subject has been assessed by the Principal Investigator and determined that no conventional distal bypass, surgical or endovascular therapy for limb salvage is feasible due to either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit.

4. Proximally, the Target In-flow Artery at the cross-over point must fall within the recommended vessel diameter ranges for the LimFlow stent graft by visual estimation.

5. Subject is willing and able to sign the informed consent form.

6. Subject is enrolled in an acceptable wound care network and has an adequate support network to ensure that subject is compliant with medication regimen and follow-up study visits.

7. Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.

8. Primary wound is stable (e.g., not rapidly deteriorating and/or showing signs of healing).

9. Stable glycemic control, HbA1C < 10% (<269mg/dL)

10. Subjects requiring dialysis may be included, provided they meet all the following

requirements:

• On dialysis for > 6 months
• Autologous arteriovenous (AV) fistula or peritoneal access used for hemodialysis
• Serum albumin > 30 g/liter
• BMI > 20

Exclusion Criteria:

1. Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days.

2. Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder.

3. Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft.

4. Absence of adequate viable tissue in target foot.

5. Life expectancy less than 12 months.

6. Documented myocardial infarction or stroke within previous 90 days.

7. Active infection (e.g., fever, significantly elevated WBC count >20.0 x 109/L, and/or positive blood culture) at the time of the index procedure that may preclude insertion of a prosthesis or require major amputation (e.g., osteomyelitis proximal to metatarsals).

8. Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated.

9. Subject is currently taking anti-coagulants, which in the opinion of the investigator, interferes with the subject's ability to participate in the study (i.e., intermittent interruption of therapy for procedure may compromise subject's safety).

10. Lower extremity vascular disease that may inhibit the procedure and/or jeopardize wound healing (e.g., vasculitis, Buerger's disease, significant edema in the target limb, deep venous thrombus in the target vein, hyperpigmentation, or medial ulceration above the ankle).

11. Significant acute or chronic kidney disease with a serum creatinine of > 2.5 mg/dl in subjects not undergoing dialysis.

12. Severe heart failure (e.g., NYHA Class IV), which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure.

13. Any significant concurrent medical, psychological, or social condition, which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.

14. The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.

15. Subject is unwilling, unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements.

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• LimFlow Stent Graft System
Creation of an arteriovenous fistula in the desired limb location

Locations

Country	Name	City	State
United States	Presbyterian Healthcare	Albuquerque	New Mexico
United States	Boston Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Atrium Health	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	The Cardiac and Vascular Institute	Gainesville	Florida
United States	University of Florida	Gainesville	Florida
United States	Penn State Health	Hershey	Pennsylvania
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Ascension Columbia St. Mary's Hospital	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Cornell University	New York	New York
United States	Mount Sinai	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Vascular Institute of Atlantic Medical Imaging	Pomona	New Jersey
United States	Washington University / Barnes Jewish	Saint Louis	Missouri
United States	UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
LimFlow, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amputation Free Survival	Freedom from major (above-ankle) amputation and death (all-cause mortality)	6 Months
Secondary	Primary Patency	Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures	30 Days
Secondary	Primary Patency	Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures	6 Months
Secondary	Primary Assisted Patency	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	30 Days
Secondary	Primary Assisted Patency	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	6 Months
Secondary	Secondary Patency	Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical or endovascular procedures after occlusion occurs	30 Days
Secondary	Secondary Patency	Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical or endovascular procedures after occlusion occurs	6 Months
Secondary	Limb Salvage	Percentage of subjects with freedom from above-ankle amputation of the index limb	30 Days
Secondary	Limb Salvage	Percentage of subjects with freedom from above-ankle amputation of the index limb	3 Months
Secondary	Limb Salvage	Percentage of subjects with freedom from above-ankle amputation of the index limb	6 Months
Secondary	Change in Rutherford Classification	A change of one class or greater	30 Days
Secondary	Change in Rutherford Classification	A change of one class or greater	3 Months
Secondary	Change in Rutherford Classification	A change of one class or greater	6 Months
Secondary	Technical Success	The successful creation of an arteriovenous fistula in the desired limb location with immediate morphological success	Intraprocedurally
Secondary	Procedural Success	The combination of technical success, and absence of all-cause death, above-ankle amputation or clinically driven major re-intervention of the stent graft	30 Days
Secondary	Target Wound Healing	Complete healing of the patient's target wound	30 Days
Secondary	Target Wound Healing	Complete healing of the patient's target wound	3 Months
Secondary	Target Wound Healing	Complete healing of the patient's target wound	6 Months
Secondary	Target Wound Healing	Complete healing of the patient's target wound	12 Months
Secondary	All Wound Healing	Complete healing of the patient's wounds	30 Days
Secondary	All Wound Healing	Complete healing of the patient's wounds	3 Months
Secondary	All Wound Healing	Complete healing of the patient's wounds	6 Months
Secondary	All Wound Healing	Complete healing of the patient's wounds	12 Months
Secondary	All Wound Area Reduction	Reduction in area of the patient's wounds	30 Days
Secondary	All Wound Area Reduction	Reduction in area of the patient's wounds	3 Months
Secondary	All Wound Area Reduction	Reduction in area of the patient's wounds	6 Months
Secondary	All Wound Area Reduction	Reduction in area of the patient's wounds	12 Months
Secondary	Freedom from Contrast-Induced Nephropathy	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.	72 hours
Secondary	Procedure Time	The time of the first puncture (venous or arterial) to when the last catheter is removed	Intraprocedurally
Secondary	Radiation Exposure	Patient radiation exposure (in milligray) during the procedure	Intraprocedurally
Secondary	Contrast Volume	The total volume of contrast media (in milliliters) given during the procedure	Intraprocedurally