Patients with a severe form of peripheral artery disease had low amputation rates, improved wound healing, and better quality of life 6 months after a procedure to reroute blood flow using LimFlow system, a new study found.

The findings of the PROMISE III study may offer hope for patients with “no-option” chronic limb-threatening ischemia (CLTI), who often face amputation because of complications that rule out traditional surgery or angioplasty.

The FDA approved LimFlow (Stryker) in 2023 for transcatheter arterialization of deep veins (TADV) in no-option patients with CLTI. The system has three components: an arteriovenous crossing system, a valvulotome to prepare veins with minimal tissue damage, and a set of specially designed stents to divert blood flow from vein to artery.

The agency approved the device based on data from the PROMISE II clinical study, in which 67 of patients with no-option CLTI undergoing TADV with the LimFlow system were able to avoid above-ankle amputation. More than 75% of the patients in PROMISE II had wounds completely healed or wounds in the process of healing after TADV.

PROMISE III was presented at the Society for Cardiovascular Angiography and Intervention (SCAI) 2026.

Impacts on Quality of Life

“What’s forgotten in many of these patients is the fact that they suffer from pain, poor quality of life, emotional distress, disruption of usual activities, and social isolation because of the wounds and ulcers that they have in their feet,” Mehdi Shishehbor, DO, MPH, PhD, said during a news conference.

About 20%-30% of patients with CLTI do not qualify for surgical bypass or endovascular revascularization because of desert foot, a condition in which all of the main arteries of the foot are occluded, said Shishehbor, an interventional cardiologist at the University Hospitals Harrington Heart & Vascular Institute in Cleveland.

“Basically, we are taking the blood flow from the arteries at the proximal tibials and diverting into the healthy veins, bringing oxygenated blood to the foot to heal the wounds, bypassing the blockages in the mid- to distal tibial arteries,” Shishehbor said.

In the PROMISE III study, Shishehbor and his collaborators enrolled 100 patients at 24 sites in the US. To qualify for study inclusion, patients must not have been candidates for distal bypass and also lacked a usable pedal artery target for endovascular revascularization or had a pedal artery target but lacked a viable single-segment donor vein. All patients also had Rutherford 5 or 6 peripheral artery disease and a nonhealing ischemic ulcer.

The researchers tracked amputation-free survival at 6 months, wound healing, pain, and quality of life as outcome measures.

Promising Outcomes

Most patients in the trial were men, and most had diabetes and hypertension. The median age was 71 years. The TADV procedure was a success in 97% of the patients. After 6 months, 93.8% of patients were still alive. The rate of amputation-free survival was 80.7%, and 86.5% avoided above-ankle amputation.

At 1 month after the TADV procedure, 47% had worsening wounds and 30% had stable wounds. After 6 months, only 10% had worsening wounds and 10% had stable wounds. The remaining 80% had healing or healed wounds.

Patients’ pain and quality of life shifted as well. The median pain score decreased from 6 out of 10 at baseline to 2, while various quality-of-life measures including concerns about circulation, social activities, sleep, and feelings of burden improved significantly.

“These are folks who have already had multiple surgeries — either bypass or endovascular procedures — to save their limb, and they have failed, and now we are labeling them as ‘no option,’” Shishehbor said.

He noted that clinicians will occasionally attempt conservative treatment in these patients, but they eventually die or end up with amputation due to suffering, pain, and wounds.

“The mortality from this condition at 1 year is 25%. At 5 years, 50%,” Shishehbor said.

Wound Healing Is Key

Shishehbor highlighted the PROMISE III wound healing data as particularly important in illustrating the benefits of TADV.

“It’s one thing to save the limb, but the wound healing really speaks to the perfusion and blood flow,” he said, adding that wound healing is closely related to quality of life. “As people’s wounds are healing or have healed, they can wear regular shoes. They don’t have to go every week or every other week to the podiatrist. They don’t have to do wound care.”

The PROMISE III results are highly encouraging, said Alejandro Fabiani, MD, director of the Center for Vascular Medicine at Hospital Zambrano Hellion in Monterrey, Mexico. “The trial demonstrates that advanced limb salvage strategies may offer clinically meaningful outcomes in patients who historically would have had few alternatives beyond major amputations.”

Fabiani, who was not involved in the study, also said the definition of a no-option CLTI patient is not yet standardized. In April, Fabiani and collaborators, including the International Cooperative Vascular Consortium, published an article in the British Journal of Surgery proposing a consensus definition of no-option and poor option for revascularization of patients with CLTI.

The definition takes into consideration arterial disease anatomy, biology, risk, function, and context. Under that framework, patients were classified as no-option if they presented with desert foot, prohibitive medical risk, a nonfunctional limb, or had refused revascularization.

“The trial highlights the urgent need for reproducible definitions and phenotypic classification systems for no-option CLTI,” Fabiani said. “Without clearer patient stratification, comparing outcomes across studies and therapies becomes extremely difficult.”

Shishehbor reported receiving consulting fees from Abbot Vascular, Advanced Nano Therapies, Boston Scientific Corporation, Medtronic, Philips, and Terumo. He also disclosed intellectual property ownership in a pulmonary artery filler. Fabiano reported having no relevant financial relationships.

Catherine Shaffer is a freelance science and medical writer with a background in molecular biology and pharmaceutical research. Her work has appeared extensively in scientific trade and mainstream publications and on public radio.