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





Participating Centers
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 Medical Center | 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 |
Harbor-UCLA Medical Center | Torrance, California | Mark Archie, Nichil Kansal |
New Mexico Heart Institute | Albuquerque, New Mexico | Steve Henao |
Ochsner Health Center | Kenner, Louisiana | Zola N’Dandu |
Prisma Health-USC Medical Group | Columbia, South Carolina | Dan Clair and Bruce Gray |
Saint Luke's Hospital of Kansas City | Kansas City, Missouri | Mathew Bunte |
UnityPoint Health | Des Moines, Iowa | Eric Scott |
University Hospitals Harrington Heart & Vascular Institute | Cleveland, Ohio | Mehdi Shishehbor |
University of California San Francisco | San Francisco, California | Peter Schneider |
Yale School of Medicine | New Haven, Connecticut | Cassius Chaar |


“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