Transcatheter Venous Arterialization Improves Outcomes in No-Option Limb Ischemia Patients

Chronic limb-threatening ischemia (CLTI) is an advanced stage of peripheral artery disease in which plaque narrows leg arteries and severely restricts blood flow, leading to pain, nonhealing wounds, and amputation risk. Many patients undergo revascularization, yet a subset has no viable option because of vessel damage, age, or comorbidities. Poor circulation and persistent wounds drive functional decline and impaired sleep. To help address this challenge, investigators evaluated a minimally invasive venous arterialization approach designed for patients with no revascularization alternative.

Transcatheter arterialization of the deep veins (TADV) using Stryker's LimFlow System diverts oxygenated blood from a blocked tibial artery into a healthier adjacent vein to restore perfusion to the foot. Late-breaking findings were presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2026 Scientific Sessions and Canadian Association of Interventional Cardiology Summit in Montreal. 

PROMISE III is a prospective, multicenter, single-arm study that enrolled 100 patients with the most severe chronic limb-threatening ischemia for treatment with TADV. Investigators used the Rutherford classification to confirm advanced disease with minor or major tissue loss. The primary endpoint of amputation-free survival was met in data reported at Vascular InterVentional Advances 2025, with 80.7% of patients surviving without major amputation at six months.

A prespecified secondary analysis assessed patient-reported quality of life using the VascuQoL-6 survey from baseline to six months. Patients’ concern about poor leg circulation decreased from 90% at baseline to 45% at six months, and limitations in social participation attributed to circulation fell from 72% to 40%. Sleep problems declined from 85% to 40%, and the daily impact of a foot wound declined from 79% to 39%, indicating broad functional gains alongside limb salvage.

The authors noted opportunities to improve efficacy, shorten procedure time, and refine patient selection in future studies. They also advised that clinicians who do not offer this technology consider referring appropriate patients to centers that do. These results suggest TADV may offer a viable option for patients otherwise facing high risks of amputation and persistent morbidity.

The authors noted opportunities to improve efficacy, shorten procedure time, and refine patient selection in future studies. They also advised that clinicians who do not offer this technology consider referring appropriate patients to centers that do. These results suggest TADV may offer a viable option for patients otherwise facing high risks of amputation and persistent morbidity.

"This is the first time PROMISE III's quality-of-life measurements have been modified to include patient-centric metrics. Our findings point to a promising new option for CLTI patients, offering another tool in the toolbox for individuals who have no other treatment avenues," said lead researcher Mehdi H. Shishehbor, DO, MPH, Ph.D., FSCAI, interventional cardiologist at University Hospitals in Cleveland, Ohio. 

"Every operator who treats this population should be aware of the procedure's potential, and those who are unable to offer the technology should consider referring their patient to a clinic that does," added Dr. Shishehbor.

Related Links
Society for Cardiovascular Angiography & Interventions