PROMISE III: Substantial Amputation-Free Survival With LimFlow TADV in CLTI

Primary 6-month data from the PROMISE III study of transcatheter arterialization of the deep veins (TADV) with the LimFlow System has shown 86% limb salvage and 80.7% amputation-free survival in patients with no-option chronic limb-threatening ischemia (CLTI).1

These data were presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2026 Scientific Sessions in Montreal, Quebec, by Mehdi Shishehbor, DO, PhD, president of the Harrington Heart & Vascular Institute at University Hospitals. The editorial team at HCPLive spoke with Shishehbor to discuss the broader implications of this study for patients with CLTI.1

“These are folks with gangrene and ulcers, with diabetes and vascular disease, at risk of major amputation, and they are considered not eligible for standard therapies of revascularization, meaning endovascular or surgical bypass,” Shishehbor told HCPLive. “So when you’re talking about 86% limb salvage in a cohort of patients that have no option, that’s pretty good odds. That’s a pretty good outcome.”

PROMISE III is an ongoing prospective, single-arm, multi-center study aiming to provide additional information on the LimFlow System for creating an AV connection in the Below The Knee (BTK) vascular system via an endovascular, minimally invasive approach to arterialize the pedal veins. The study was conducted across 30 locations in the US and is expected to continue out to 12 months of follow-up.2

Patients were eligible for inclusion if they had a clinical diagnosis of CLTI with Rutherford Classification 5, ischemic ulceration, or Rutherford Classification 6, ischemic gangrene. Additionally, the Target In-flow Artery at the cross-over point had to fall within the recommended diameter ranges for the LimFlow stent graft, and patients had to have stable glycemic control, among other criteria. Patients were excluded if they had concomitant hepatic insufficiency, thrombophlebitis in the target limb, absence of adequate tissue in the target foot, or active immunodeficiency disorders, among other criteria.2

The study’s primary outcome is amputation-free survival, defined as freedom from major above-ankle amputation and all-cause mortality, at 6 months. Secondary outcomes included primary and secondary patency at 30 days and 6 months, limb salvage at 30 days, 3 months, and 6 months, change in Rutherford classification at 30 days, 3 months, and 6 months, and target wound healing at 30 days and 3, 6, and 12 months, among others.2

A total of 100 patients, resulting in 103 limbs, were enrolled in the study and underwent TADV. All 103 had non-healing ulcers or gangrene, of which 74.8% were Rutherford class 5 and 25.2% were class 6. By 6 months, the primary endpoint of amputation-free survival was 80.7%, while limb salvage was 86.5% and survival was 93.8%. Roughly 80% of all wounds had either completely healed or were healing.1

Shishehbor and colleagues also noted a median pain score of 2.0 at 6 months, which had substantially dropped from a baseline of 6.0 (P <.0001). Significant improvements were also recorded in quality-of-life metrics at 6 months versus baseline, including concerns about poor circulation, ability to fall or stay asleep, feeling burdened by the wound, and ability to participate in social activities.1

“We are very proud and very excited, and this builds on other data that we have had,” Shishehbor said. “We have had PROMISE I, PROMISE II, PROMISE UK, and now PROMISE III, and they just show that we’re doing a little bit better each time.”

Editors’ Note: Shishehbor reports serving as a consulting and advisory board for ANT, Inquis, Abbott Medical, Medtronic, Boston Scientific, and Inari.

References

1. Shishehbor M. PROMISE III: 6-Month Clinical and Quality of Life Outcomes in CLTI Patients Treated with Transcatheter Arterialization of the Deep Veins. Presented at the Society for Cardiovascular Angiography and Interventions 2026 Scientific Sessions, Montreal, Quebec. April 23-25, 2026.

2. LimFlow, Inc. PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia. ClinicalTrials.gov Identifier: NCT05313165. Updated April 16, 2026. Accessed May 12, 2026. https://clinicaltrials.gov/study/NCT05313165