Are you facing amputation of your leg or foot?
Chronic Limb-Threatening Ischemia (CLTI) is the most severe form of peripheral arterial disease (PAD). It cuts off blood flow to the lower leg and foot, resulting in severe leg pain, wounds that won’t heal and, ultimately, amputation.
If you are facing amputation due to CLTI, the PROMISE II study may offer you a treatment option.
About the Trial
The PROMISE II Trial is studying whether an investigational, minimally-invasive medical procedure that avoids major surgery can prevent foot or lower leg amputation and promote wound healing.
People with the following criteria may qualify to participate in the study:
- Adult patient
- May or may not have been diagnosed with Chronic Limb-Threatening Ischemia
- Severe leg pain, even when at rest
- Foot ulcers that are not healing
- Doctor’s recommendation to consider amputation of the foot or leg
- Not eligible for further conventional endovascular or surgical treatments to resolve artery blockage or CLTI
|Site Name||Site Location||Physician|
|Atrium Health||Charlotte, North Carolina||Greg Stanley, Frank Arko|
|Baylor College of Medicine||Houston, Texas||Joseph Mills / Miguel Montero-Baker|
|Boston Medical Center||Boston Massachusetts||Alik Farber|
|Cardiac and Vascular Institute in Gainesville||Gainesville, Florida||Art Lee|
|Caribbean Vascular Center||Ponce, Puerto Rico||Jorge Martinez Trabal|
|Coastal Carolina Surgical Associates||Wilmington, North Carolina||David Weatherford|
|Dartmouth – Hitchcock Medical Center||Lebanon, New Hampshire||Richard Powell|
|Denver VA||Denver, Colorado||Ehrin Armstrong|
|Harbor-UCLA Medical Center||Torrance, California||Mark Archie/ Nichil Kansal|
|Inova Medical Group||Falls Church, Virginia||Richard Neville|
|Keck School of Medicine of USC||Los Angeles, California||David Armstrong/Vincent Rowe|
|New Mexico Heart Institute||Albuquerque, New Mexico||Steve Henao|
|Ochscner Health Center||Kenner, Louisiana||Zola N’Dandu|
|Prisma Health-USC Medical Group||Columbia, South Carolina||Dan Clair and Bruce Gray|
|Rex Healthcare||Raleigh, North Carolina||George Adams|
|University Hospitals Harrington Heart & Vascular Institute||Cleveland, Ohio||Mehdi Shishehbor|
|University of California San Francisco||San Francisco, California||Peter Schneider|
|UT Health||San Antonio, Texas||Mark Davies/Lucas Ferrer – UT San Antonio|
About LimFlow Therapy
“This is the biggest advance I’ve seen for people at risk of amputation in my 25 years in practice.”
Dr. Daniel Clair, Principal Investigator for PROMISE II Trial,
University of South Carolina/Palmetto Health
Designed to bypass blocked arteries in the leg and foot to create a clear channel from the open artery above the blockage to an open vein. This is intended to return blood flow back to the lower leg and foot and enable wound healing
Involves catheters, stents, an artery-to-vein crossing system, and a unique device that disables valves in the vein, reversing flow in the vein so that blood can flow down to the foot.
Approximately 150 patients have been treated to date in the US, Europe, Asia and Latin America
Hear from patients and doctors participating in clinical study of the LimFlow system
About Chronic Limb-Threatening Ischemia
Peripheral Artery Disease is a condition that narrows your arteries, reducing the flow of blood going down your legs and into your feet. In its most severe form, it progresses to Chronic Limb-Threatening Ischemia (CLTI), which is a complete blockage of blood flow and oxygen. People with CLTI who are not eligible for further conventional endovascular or surgical treatments to resolve the blockage are known as no option CLTI patients. Their only alternative becomes amputation of the affected foot or lower leg in order to avoid systemic infection and sepsis that may lead to death.
The LimFlow Therapy is an investigational, minimally-invasive treatment designed to divert blood flow around blocked arteries, through veins in the lower leg, and into the foot. It is being studied in the PROMISE II clinical study.
The LimFlow system is currently investigational in the US; only participants in the PROMISE II clinical study are eligible to receive the treatment at this time.
LimFlow therapy is a minimally-invasive procedure involving catheters, stents, and a unique device that disables valves in the vein so that blood can flow down to the foot.
Up to 120 patients are expected to participate in the PROMISE II clinical study.
Patients participating in the PROMISE II study will have follow-up doctor’s visits and tests for three years following treatment.
Your participation in the clinical study is voluntary, and you may withdraw at any time. However, your participation in the study will provide additional information on the performance of LimFlow therapy, which may prove beneficial to you and other patients in the future.
If you fit the preliminary criteria for potential candidates in the study, you can click here to learn more or call (888) 478-7705 for more information.
Each patient enrolled in the study will be asked to sign an Informed Consent document explaining the procedure along with risks and potential benefits. You will be asked to complete various tests to confirm your eligibility for the study prior to having the procedure. You will also be asked to come back for follow-up visits and tests for the next three years.
During this follow-up period, subjects will be assessed at different timepoints, post-procedure. These assessments are measures of safety and effectiveness and will be performed at 14 days, 30 days, at 2, 3, 6, and 9 months, at 1 year, 2 years, and 3 years post-procedure.
During the visits, your doctor may perform an examination, collect imaging scans, and perform other tests they deem necessary to monitor your treatment. The follow-up tests and evaluations outlined in this study are standard routine exams.
Your name or other identifying information will be protected and will not be recorded in study documents. Instead, a unique subject identifier will be assigned to record information.
There are no direct benefits guaranteed to you as a result of participating in this study. However, possible benefits include the potential for improved blood flow to the foot and the possibility of wound healing.
The study may also produce other unexpected risks and benefits. Any new and significant information or findings will be provided to you by your doctor. In addition, if the treatment is found to be effective, this will lead to improved treatment for patients who have a condition similar to yours.
Yes. As with any medical procedure, there are risks associated with doing this procedure. The most common risks are listed below. A more detailed list is provided as part of the Informed Consent document you will sign in order to participate in the study. You may also speak with your doctor if you have any questions about these risks.
- Edema of the legs, which is swelling at the area which was previously not receiving blood flow and is now receiving it
- Allergic reaction, including anaphylactic shock and allergic swelling
- Vascular complications at access site, including bleeding events and hematoma
- Events that may be related to blood clots
- Contrast-induced nephropathy and renal failure (kidney damage)
- If problems occur, it may result in the need for additional procedures, surgery, or amputation
The sponsor, LimFlow Inc., will reimburse the hospital for the cost of activities performed in connection with this study. There are no additional costs to the patient associated with participation in this study.
Your participation is voluntary, and you may withdraw at any time. While no benefit from your participation can be guaranteed, your involvement in the study may provide additional information on the performance of the LimFlow System, which may prove beneficial to you and to future patients.
- Reinecke H, Unrath M, Freisinger E, Bunzemeier H, Meyborg M, Lüders F, et al. Peripheral arterial disease and critical limb ischaemia:
still poor outcomes and lack of guideline adherence. Eur Heart J. 2015 Apr 14;36(15):932-8.
- Mustapha J. The relationship between amputation and mortality: It’s time to discuss the obvious. Paper presented at the Visionary
Endovascular & Vascular Education Symposium (VERVE), Sydney, Australia. 2016 Dec.
- Yost M. Cost-benefit analysis of critical limb ischemia in the era of the Affordable Care Act. Endovascular Today. 2014 May.
- Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FGR. Inter-society consensus for the management of peripheral
arterial disease (TASC II). J Vasc Surg. 2007 Jan;45(1):S5-67.
- Palli SR, Gunnarsson C, Kotlarz H, Martinsen B, Ruizhi Z, Rizzo JA. Impact of a limb salvage program on the economic burden of
amputation in the United States. Value Health. 2016 May;19(3):A45.
- Yost, Mary. “Cost-Benefit Analysis Of Critical Limb Ischemia In The Era Of The Affordable Care Act”. Endovascular Today, 2019, https://evtoday.com/pdfs/et0514_F2_Yost.pdf. Accessed May 2014.
- Norgren, L. et al., Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) Journal of Vascular Surgery , Volume 45 , Issue 1 , S5 – S67