One-year outcomes from the PROMISE I, II, and UK Studies of no-option chronic limb-threatening ischemia patients undergo

Published Date: 12th November 2025

Publication Authors: Lechareas. S

Purpose
A subset of patients with chronic limb-threatening ischemia (CLTI) are ineligible for conventional open or endovascular treatment options. This challenging "no-option" patient population has poor 1-year outcomes, including >50% major amputation rate. Transcatheter arterialization of the deep veins (TADV) has demonstrated positive outcomes. Here, we present the 1-year pooled outcomes of the largest cohort of prospectively-studied patients treated with the LimFlow System (Inari Medical, Irvine, CA, USA).

Material(s) and Method(s)
The PROMISE I, II, and UK studies were single-arm, multicenter, prospective studies evaluating the safety and effectiveness of TADV for no-option CLTI patients. Eligibility criteria included Rutherford class 5/6 and independent confirmation of no-option status. Outcomes assessed in the pooled cohort included amputation-free survival, survival, and survival through 1 year. Wound status and pain were also evaluated.

Result(s)
A total of 137 patients were included from the 3 studies. The median age was 71 years and 73% were male. The technical success of the TADV procedure was high at 97.8%. At 1 year, the amputation-free survival rate was 66.1%, the limb salvage rate was 74.4%, and the survival rate was 88.9%. The proportion of patients with healed or healing wounds at 1 year was 83%. The mean pain score at 1 year was 1.8, which was significantly reduced from 5.4 at baseline (p<0.001).

Conclusions
TADV with the LimFlow System showed promising outcomes for no-option CLTI patients, with a high limb salvage rate and a large proportion of patients with healed or healing wounds at 1 year.

Van Den Heuvel, D; Lechareas, S. (2025). One-year outcomes from the PROMISE I, II, and UK Studies of no-option chronic limb-threatening ischemia patients undergo. CardioVascular and Interventional Radiology. 48(Suppl 4), p.S560. [Online]. Available at: https://dx.doi.org/10.1007/s00270-025-04245-x [Accessed 8 January 2026]