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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.

U.S. PROMISE II Clinical Trial

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
U.S. PROMISE II Clinical Trial
U.S. PROMISE II Clinical Trial

Participating Centers

Atrium Health
Charlotte, North Carolina
Dr. Greg Stanley, Dr. Frank Arko
Baylor College of Medicine
Houston, Texas
Dr.Joseph Mills, Dr.Miguel Montero-Baker
Boston Medical Center
Boston Massachusetts
Dr.Alik Farber
Cardiac and Vascular Institute in Gainesville
Gainesville, Florida
Dr.Art Lee
Caribbean Vascular Center
Ponce, Puerto Rico
Dr. Jorge Martinez Trabal
Coastal Carolina Surgical Associates
Wilmington, North Carolina
Dr.David Weatherford
Dartmouth – Hitchcock Medical Center
Lebanon, New Hampshire
Richard Powell
Harbor-UCLA Medical Center
Torrance, California
Dr.Mark Archie, Dr.Nichil Kansal
Saint Luke's Hospital of Kansas City
Kansas City, Missouri
Mathew Bunte
New Mexico Heart Institute
Albuquerque, New Mexico
Dr.Steve Henao
Ochscner Health Center
Kenner, Louisiana
Dr.Zola N’Dandu
Prisma Health-USC Medical Group Columbia,
South Carolina
Dr.Dan Clair, Dr.Bruce Gray
University Hospitals Harrington Heart & Vascular Institute
Cleveland, Ohio
Dr.Mehdi Shishehbor
University of California San Francisco
San Francisco, California
Dr.Peter Schneider
University of Texas at Austin
Austin, Texas
Lucas Ferrer
Site NameSite LocationPhysician
Atrium HealthCharlotte, North CarolinaGreg Stanley, Frank Arko
Baylor College of MedicineHouston, TexasJoseph Mills / Miguel Montero-Baker
Boston Medical CenterBoston Medical CenterAlik Farber
Cardiac and Vascular Institute in GainesvilleGainesville, FloridaArt Lee
Caribbean Vascular CenterPonce, Puerto RicoJorge Martinez Trabal
Coastal Carolina Surgical AssociatesWilmington, North CarolinaDavid Weatherford
Dartmouth – Hitchcock Medical CenterLebanon, New HampshireRichard Powell
Harbor-UCLA Medical CenterTorrance, CaliforniaMark Archie, Nichil Kansal
New Mexico Heart InstituteAlbuquerque, New MexicoSteve Henao
Ochsner Health CenterKenner, LouisianaZola N’Dandu
Prisma Health-USC Medical GroupColumbia, South CarolinaDan Clair and Bruce Gray
Saint Luke's Hospital of Kansas CityKansas City, MissouriMatthew Bunte
UnityPoint HealthDes Moines, IowaEric Scott
University Hospitals Harrington Heart & Vascular InstituteCleveland, OhioMehdi Shishehbor
University of California San FranciscoSan Francisco, CaliforniaPeter Schneider
University of Texas at AustinAustin, TexasLucas Ferrer
Yale School of MedicineNew Haven, ConnecticutCassius Chaar
U.S. PROMISE II Clinical Trial

“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