QoL Analysis Reported From PROMISE III Trial of Transcatheter Arterialization of the Deep Veins for CLTI

May 6, 2026—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).

The findings from PROMISE III, which was led by Mehdi H. Shishehbor, DO, were presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2026 scientific sessions.

According to SCAI, the prospective, multicenter, single-arm study enrolled 100 patients with the most extreme levels of CLTI for TADV treatment using the LimFlow system (Stryker). The investigators used the Rutherford classification system to determine CLTI extremity, selecting patients with minor or major tissue loss.

PROMISE III trial’s primary endpoint of amputation-free survival (AFS) was met and the data were presented at VIVA 2025, the Vascular Interventional Advances conference. The 6-month outcomes found 80.7% of patients who underwent TADV survived without major amputation.

As noted by SCAI, the investigators conducted a secondary analysis of patients’ QoL after TADV to determine a comprehensive understanding of the procedure’s outcomes on this patient population.

The findings presented at SCAI 2026 suggest that no-option CLTI patients who underwent TADV experienced significant QoL benefits at 6 months after the procedure, compared to directly before (baseline).

Using a comprehensive questionnaire based on the VascuQoL-6 survey to determine changes in patients in the PROMISE III trial reported the following benefits from baseline to 6 months after TADV:

• Patients’ concerns about poor circulation in their legs declined from 90% to 45%.
• The inability to participate in social activities because of poor circulation declined from 72% to 40%.
• Trouble falling asleep, staying asleep, or sleeping too much declined from 85% to 40%.
• The daily toll of a foot wound declined from 79% to 39% at 6 months.

“This is the first time PROMISE III’s QoL measurements have been modified to include patient-centric metrics,” commented Dr. Shishehbor in the SCAI press release. “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.”

Dr. Shishehbor added, “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.”