New Options

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 your doctor has suggested amputation of your foot or lower leg to resolve non-healing wounds and pain, the PROMISE III study may offer you a treatment option.

About the Trial

The PROMISE III 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

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Participating Centers

Physician	Site Name	Site Location
Chandra Venita	Stanford University Medical Center	Palo Alto, CA
Michael Conte	UCSF Medical Center	San Francisco, CA
Shant Vartanian	UCSF Medical Center	San Francisco, CA
Mark Archie	Harbor-UCLA Medical Center	Torrance, CA
Edouard Aboian	Yale New Haven Hospital	New Haven, CT
Cassius Iyad Ochoa Chaar	Yale University	New Haven, CT
Arthur Lee	The Cardiac and Vascular Institute	Gainesville, FL
Benjamin Jacobs	University of Florida	Gainesville, FL
Sreekumar Madassery	Rush University Medical Center	Chicago, IL
Anahita Dua	Massachusetts General Hospital	Boston, MA
Douglas Jones	University of Massachusetts Chan Medical School	Worcester, MA
Gregory Stanley	Atrium Health	Charlotte, NC
Richard Powell	Dartmouth-Hitchcock Medical Center	Hanover. NH
Richard Powell	Dartmouth – Hitchcock Medical Center	Lebanon, NH
Jocelyn Beach	Dartmouth – Hitchcock Medical Center	Lebanon, NH
Nicholas Petruzzi	Cooper Univeristy Hospital, Cape Regional Medical Center	Cape May, NJ
	Atlanticare Atlantic Medical Imaging	Galloway, NJ
	Inspira Health Network	Galloway, NJ
	Atlanticare	Atlantic City, NJ
	Vascular Institute of Atlantic Medical Imaging (VIAMI)	West Atlantic City, NJ
Kevin Herman	Holy Name	Teaneck, NJ
Steve Henao	Presbyterian Healthcare Services	Albuquerque, NM
Yana Etkin	Long Island Jewish Medical Center	Long Island, NY
Jeffrey Silpe	North Shore University Hospital	Manhasset, NY
Jeffrey Silpe	Long Island Jewish Medical Center	New York, NY
Garg Karan	NYU Langone Health	New York, NY
Prakash Krishnan	Icahn School of Medicine at Mount Sinai	New York, NY
Brian DeRubertis	Weill Cornell Medicine	New York, NY
Mehdi Shishehbor	University Hospitals Cleveland Medical Center	Cleveland, OH
Elizabeth Genovese	Hospital of the University of Pennsylvania	Philadelphia, PA
Tarik Ali	Penn State Health	Philadelphia, PA
Daniel Clair	Vanderbilt University Medical Center	Nashville, TN
Michael Siah	UT Southwestern Medical Center	Dallas, TX
David Dexter	Sentara Norfolk General Hospital/Sentara Heart Hospital	Norfolk, VA

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“There is an epidemic of lower limb amputation due to ischemia in the United States and LimFlow offers a very promising alternative for these patients to potentially heal their wounds and keep their feet.”

Mehdi H. Shishehbor, DO, MPH, PhD
Professor of Medicine,
Case Western Reserve University School of Medicine
University Hospitals Cleveland Medical Center
Case Western Reserve University

About LimFlow Therapy

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

Designed to bypass blocked arteries in the leg and foot, preventing amputation, relieving pain and enabling wound healing

Minimally-invasive treatment

Trial FAQs

What is LimFlow therapy?
Can I receive LimFlow therapy without joining the study?
What does LimFlow therapy involve?
How many people can participate in the study?
What if I join the study and decide I do not want to participate anymore?

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.
I am not ready to go through the pre-screening process but I have additional questions. How can I get more information?
I am interested in hearing more. What is the next step?
What can I expect if I choose to participate in the study?

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.
How often will I be seen?

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 3 and 6 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.
Will my personal health information be kept private?
What are the benefits of participating in this study?

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.
Are there any potential risks?
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)

Infection

Pain

If problems occur, it may result in the need for additional procedures, surgery, or amputation
How much will it cost?
There may be additional costs related to your participation in the study. You and your healthcare plan may be responsible to pay for the one or more of the items listed below:

Items or services needed to give you study drugs or devices

Monitoring for potential side effects or study related issues

Items and services that would have been provided to you even if you were not in the study

Health care that is not related to your participation in this study
Do I have a choice to participate or not?

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.

Are you facing amputation
of your leg or foot?

About the Trial

People with the following criteria may qualify to participate in the study:

Participating Centers

“There is an epidemic of lower limb amputation due to ischemia in the United States and LimFlow offers a very promising alternative for these patients to potentially heal their wounds and keep their feet.”

About LimFlow Therapy

Trial FAQs

LimFlow Story:

Privacy:

Contact:

info@limflow.com
+1 (877) 923-4747

Are you facing amputationof your leg or foot?

About the Trial

People with the following criteria may qualify to participate in the study:

Participating Centers

“There is an epidemic of lower limb amputation due to ischemia in the United States and LimFlow offers a very promising alternative for these patients to potentially heal their wounds and keep their feet.”

About LimFlow Therapy

Trial FAQs

Are you facing amputation
of your leg or foot?