The PROMISE II Trial, Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia (PROMISE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03970538|
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : March 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Critical Limb Ischemia Critical Lower Limb Ischemia Peripheral Artery Disease Peripheral Arterial Disease Chronic Limb-Threatening Ischemia Arterial Occlusive Diseases Arterial Occlusion Arterial Disease Peripheral Artery Occlusion Peripheral Vascular Disease Peripheral Ischemia Vascular Diseases||Device: LimFlow System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, multi-center pivotal study|
|Masking:||None (Open Label)|
|Official Title:||Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: the PROMISE II Trial|
|Actual Study Start Date :||December 6, 2019|
|Estimated Primary Completion Date :||July 30, 2021|
|Estimated Study Completion Date :||December 30, 2023|
Experimental: Treatment Arm
Treated with the LimFlow System
Device: LimFlow System
Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia
- Amputation Free Survival (AFS) [ Time Frame: 6 months post-procedure ]freedom from major amputation and death at 6 months, compared to a historical performance goal.
- Primary Patency [ Time Frame: 30 days and 6 months post-procedure ]Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures.
- Primary Assisted Patency [ Time Frame: 30 days and 6 months post-procedure ]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.
- Secondary Patency [ Time Frame: 30 days and 6 months post-procedure ]Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical endovascular procedures after occlusion occurs.
- Limb Salvage [ Time Frame: 30 days, 3 and 6 months post-procedure ]The percentage of subjects with freedom from above-ankle amputation of the index limb.
- Change in Rutherford Classification [ Time Frame: 30 days, 3 and 6 months post-procedure ]A change of one Rutherford class or greater.
- Technical Success [ Time Frame: Immediately post-procedure ]The successful creation of an arteriovenous fistula in the desired limb location with immediate morphological success.
- Procedure Success [ Time Frame: 30 days post-procedure ]Combination of Technical Success, and absence of all-cause death, above-ankle amputation or clinically driven major re-intervention of the stent graft.
- Target Wound Healing [ Time Frame: 30 days, 3, 6, 9, and 12 months post-procedure ]Complete healing of the patient's target wound
- All Wound Healing [ Time Frame: 30 days, 3, 6, 9, and 12 months post-procedure ]Complete healing of the patient's wounds.
- Freedom from Contrast-Induced Nephropathy [ Time Frame: Within the first 72 hours post-procedure ]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.
- Procedure Time [ Time Frame: Immediately post-procedure ]Time from the first puncture (venous or arterial) to when the last catheter is removed
- Radiation Exposure [ Time Frame: During the procedure ]Patient radiation exposure (measured in milligray)
- Contrast Volume [ Time Frame: During the procedure ]Total volume of contrast media (measured in milliliters)
- All Wound Area Reduction [ Time Frame: 30 days, 3, 6, 9, and 12 months post-procedure ]Defined as reduction in area of the patient's wounds
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970538
|Contact: Thomas Engels||888-478-7705 ext 101||Tengels@limflow.com|
|Contact: Cecilia Petrellafirstname.lastname@example.org|
|Principal Investigator:||Daniel Clair, MD||Prisma Health|