Transcatheter arterialization of the deep veins improves quality of life for no-option CLTI patients

Data from the PROMISE III trial suggest that chronic limb-threatening ischemia (CLTI) patients with no other treatment options experienced significant quality of life (QoL) improvements after undergoing transcatheter arterialization of the deep veins (TADV). Researchers presented the late-breaking data today at the Society for Cardiovascular Angiography & Interventions (SCAI) 2026 Scientific Sessions & Canadian Association of Interventional Cardiology/Association Canadienne de cardiologie d'intervention (CAIC-ACCI) Summit in Montreal.

CLTI is a severe stage of peripheral artery disease (PAD) that occurs when a buildup of plaque significantly narrows the arteries in the legs, restricting blood flow from the lower limbs. The condition affects over 20 million people worldwide. The most common treatment method is revascularization, which aims to restore blood flow through minimally invasive or surgical techniques. However, around one in 10 CLI patients lack viable options for revascularization due to age, damaged arteries, or complication risks like amputation, heart failure, or kidney disease. TADV is an emerging minimally invasive stent that reroutes blood through a healthier vein, bypassing the blocked leg artery and restoring blood to the foot.

PROMISE III is a prospective, multicenter, single-arm study that enrolled 100 patients with the most extreme levels of CLTI for TADV treatment using the LimFlow™ System (Stryker). Researchers used the Rutherford classification system to determine CLTI extremity, selecting patients with minor or major tissue loss. The primary endpoint, amputation-free survival (AFS), was met with the data presented at Vascular InterVentional Advances (VIVA) 2025. Six-month outcomes found 80.7% of patients who underwent TADV survived without major amputation. To determine a comprehensive understanding of the procedure's outcomes on this patient population, researchers conducted a secondary analysis of patients' QoL following TADV.

The findings presented at SCAI suggest that no-option CLTI patients who underwent TADV saw significant QoL benefits six months after the procedure, compared to directly before (baseline, BL). Through a comprehensive questionnaire based on the VascuQoL-6 survey, researchers sought to determine changes in patients' circulation, participation in daily life, sleep, and pain/wound healing during the study period. Six months after TADV, patients were less concerned about poor circulation in their legs (BL: 90% vs. 6-mo: 45%) and their ability to participate in social activities due to poor circulation (BL: 72% vs. 6-mo: 40%). Patients reporting trouble falling asleep, staying asleep, or sleeping too much dropped from 85% to 40%, while the daily toll of a foot wound fell from 79% to 39%.

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. 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."

Mehdi H. Shishehbor, DO, MPH, PhD, FSCAI, lead researcher, interventional cardiologist at University Hospitals in Cleveland, Ohio

Future studies may be warranted to improve the efficacy of TDAV. The authors note that additional analyses may seek to improve the stent, decrease the length of the procedure, and refine patient selection.