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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
U.S. PROMISE III Clinical Trial

Participating Centers

Site NameSite LocationPhysician
AtlanticareAtlantic City, NJNicholas Petruzzi
Atrium HealthCharlotte, NCGregory Stanley
Boston Medical CenterBoston, MAAlik Farber
Dartmouth – Hitchcock Medical CenterLebanon, NHRichard Powell
Jocelyn Beach
Hospital of the University of PennsylvaniaPhiladelphia, PAElizabeth Genovese
Icahn School of Medicine at Mount SinaiNew York, NYPrakash Krishnan
Massachusetts General HospitalBoston, MAAnahita Dua
Presbyterian Healthcare ServicesAlbuquerque, NMSteve Henao
Rush University Medical CenterChicago, ILSreekumar Madassery
The Cardiac and Vascular InstituteGainesville, FLArthur Lee
University Hospitals Cleveland Medical CenterCleveland, OHMehdi Shishehbor
UCSF Medical CenterSan Francisco, CAMichael Conte
Shant Vartanian
University of FloridaGainesville, FLBenjamin Jacobs
University of Massachusetts Chan Medical SchoolWorcester, MADouglas Jones
UT Southwestern Medical CenterDallas, TXMichael Siah
Vanderbilt University Medical CenterNashville, TNDaniel Clair
Washington UniversitySt. Louis, MOPatrick Geraghty
Weill Cornell MedicineNew York, NYBrian DeRubertis
Yale UniversityNew Haven, CTCassius Iyad Ochoa Chaar
U.S. PROMISE III 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