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 have patients facing amputation from severe Peripheral Artery Disease (PAD), also known as Chronic Limb-Threatening Ischemia, a new clinical trial may offer them a new treatment option.
Refer Your Patients for a New Treatment Option
Contact a Study Center Near You
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.
Your patients 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
- Prior recommendation to consider amputation of the leg or foot
- Not eligible for further conventional endovascular or surgical treatments to resolve artery blockage or CLTI
Participating Centers
Charlotte, North Carolina
Dr. Greg Stanley, Dr. Frank Arko
Houston, Texas
Dr.Joseph Mills, Dr.Miguel Montero-Baker
Boston Massachusetts
Dr.Alik Farber
Gainesville, Florida
Dr.Art Lee
Ponce, Puerto Rico
Dr. Jorge Martinez Trabal
Wilmington, North Carolina
Dr.David Weatherford
Lebanon, New Hampshire
Richard Powell
Torrance, California
Dr.Mark Archie, Dr.Nichil Kansal
Kansas City, Missouri
Mathew Bunte
Albuquerque, New Mexico
Dr.Steve Henao
Kenner, Louisiana
Dr.Zola N’Dandu
South Carolina
Dr.Dan Clair, Dr.Bruce Gray
Cleveland, Ohio
Dr.Mehdi Shishehbor
San Francisco, California
Dr.Peter Schneider
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 |
Harbor-UCLA Medical Center | Torrance, California | Mark Archie, Nichil Kansal |
Mass General Hospital | Boston, Massachusetts | Anahita Dua |
Ochsner Health Center | Kenner, Louisiana | Zola N’Dandu |
Prisma Health-USC Medical Group | Columbia, South Carolina | Dimitrios Virvilis and Bruce Gray |
Saint Luke's Hospital of Kansas City | Kansas City, Missouri | Matthew Bunte |
UnityPoint Health | Des Moines, Iowa | Eric Scott |
University Hospitals Harrington Heart & Vascular Institute | Cleveland, Ohio | Mehdi Shishehbor |
University of Arizona Sarver Heart Center | Tucson, Arizona | Wei Zhou |
University of California San Francisco | San Francisco, California | Peter Schneider and Shant Vartanian |
University of Texas at Austin | Austin, Texas | Lucas Ferrer |
Vanderbilt University Medical Center | Nashville, Tennessee | Dan Clair |
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