PROMISE III Reports 1-Year Outcomes With TADV Using the LimFlow System

October 16, 2026—One-year results from the prospective, multicenter, single-arm PROMISE III trial evaluated transcatheter arterialization of the deep veins (TADV) with the LimFlow system (Stryker Peripheral Vascular) in patients with chronic limb-threatening ischemia (CLTI).

The findings were presented by Daniel G. Clair, MD, at VIVA 2026, the Vascular Interventional Advances conference.

According to the VIVA press release summarizing the study, a total of 100 patients (103 limbs) underwent TADV. All patients enrolled in the study had Rutherford class 5 or 6 disease and were independently determined to be ineligible for conventional endovascular or surgical revascularization.

All treated limbs had nonhealing ulcers or gangrene, with 74.8% classified as Rutherford class 5 and 25.2% as Rutherford class 6. Baseline comorbidities included diabetes in 80% of patients, hypertension in 95%, hyperlipidemia in 63%, chronic kidney disease in 46%, and dialysis dependence in 13%.

Key exclusion criteria included systemic infection, rapidly deteriorating wounds, and advanced heart failure. An independent clinical events committee adjudicated safety outcomes, and a core laboratory assessed wound images.

As summarized by VIVA, the study showed the following at 1 year:

• The Kaplan-Meier limb salvage rate was 84.1%, overall survival was 91.4%, and amputation-free survival was 76.3%.
• Median pain scores, assessed on a scale of 0 to 10, decreased from 6 at baseline to 0.
• 91.5% of treated limbs had wounds that were completely healed or healing.
• 64.1% of patients had improved to Rutherford class 4 or below, including 45.3% who were classified as Rutherford class 0.

Building on results from previous PROMISE studies evaluating TADV with the LimFlow system in patients with no-option CLTI, the 1-year PROMISE III outcomes suggest sustained limb preservation, wound healing, and symptom improvement in this high-risk population, stated the summary from VIVA.