PROMISE II Trial Evaluates TADV With Inari’s LimFlow System

November 5, 2024—Two-year outcomes from the PROMISE II trial assessed transcatheter arterialization of the deep veins (TADV) using the LimFlow System (Inari Medical).

Daniel Clair, MD, presented the PROMISE II findings in the third late-breaking clinical trials session at VIVA24, the 22nd annual Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on November 3-6 in Las Vegas, Nevada.

As summarized in the VIVA24 press release, up to 20% of patients with chronic limb-threatening ischemia (CLTI) are not eligible for conventional surgical or endovascular revascularization techniques and have a resultant amputation rate of 50% within 6 months.

An alternative option for these no-option patients is TADV with the purpose-built LimFlow System, the only FDA-approved option. The LimFlow System consists of an integrated system for arteriovenous crossing, atraumatic vein preparation, and flow diversion. 

This work reports the 2-year outcomes from the prospective, multicenter, single-arm, PROMISE II trial of the LimFlow System for TADV in no-option patients. 

All patients had Rutherford class 5/6 disease and were confirmed as ineligible for endovascular or surgical interventions by an independent physician review committee. Key exclusion criteria were systemic infection, rapidly deteriorating wounds, or advanced heart failure. Study conduct included an independent clinical events committee to adjudicate safety outcomes and a core laboratory to assess all wound images. Two-year outcomes included limb salvage, survival, amputation-free survival, wound healing, and Rutherford classification. 

A total of 105 CLTI patients underwent TADV between 2018 and 2022. At 2 years, the limb salvage rate was 65%. An improvement was seen in Rutherford classification: 65.8% of patients had Rutherford class 4 or below and 54.3% had Rutherford class 0. Wounds were completely healed/healing in 82% of patients at 2 years; the mean wound area was 0.1 cm², and the mean pain score was 1.2 out of 10. When combined with the PROMISE I trial, the 2-year limb salvage rate was 68%, with no differences observed based on age, sex, race, baseline Rutherford classification, diabetes, or dialysis.

The long-term outcomes from the PROMISE II trial represent data from the largest cohort of patients with 2-year data and demonstrate sustained limb salvage and wound healing in no-option CLTI patients, concluded the study in the VIVA24 press release.