Flow-Diverting Foot Procedure Improves QoL and Reduces Amputation Risk in CLTI, finds trial

A secondary analysis of the PROMISE III trial has shown that in patients with chronic limb-threatening ischemia (CLTI) who lack other treatment options, a blood flow–diverting procedure in the foot improves multiple quality-of-life measures and reduces the risk of major amputation.

CLTI represents the most severe form of peripheral artery disease, which often leads to chronic pain, non-healing wounds, and a high risk of amputation. Approximately 10% of patients fall into the no-option category, which are not eligible for standard surgical or endovascular revascularization. Historically, outcomes for this group have been poor, with major amputation frequently considered inevitable.

This PROMISE III trial enrolled 100 patients (covering 103 affected limbs), all classified as Rutherford class 5 or 6, being the most advanced stages of the disease. These patients presented with severe symptoms including ulcers and gangrene and were independently confirmed to have no viable conventional treatment options.

This research evaluated the effectiveness of transcatheter arterialization of the deep veins (TADV), which is a minimally invasive technique that reroutes blood flow into the venous system to restore circulation to oxygen-starved tissues. The LimFlow System is specifically designed to perform this complex procedure.

At the 6-month mark, the study met its primary endpoint with an amputation-free survival (AFS) rate of 80.7%. Limb salvage was achieved in 86.5% of cases, while overall survival reached 93.8%. These figures mark a substantial improvement when compared to historical expectations for this patient population.

Beyond survival metrics, the study also highlighted meaningful clinical improvements. Nearly 80% of patients experienced wounds that were either fully healed or actively healing within 6 months. Pain levels dropped significantly, with median scores decreasing from 6.0 at baseline to 2.0, which was highly statistically significant.

The patients reported reduced concerns about poor circulation, improved ability to engage in social activities, better sleep quality, and a decreased sense of burden from chronic wounds. These improvements illuminate the broader impact of the treatment beyond purely clinical measures.

While the study lacks a control group, its findings provide strong evidence that TADV with the LimFlow System may offer a viable path forward for patients who previously had none. Longer-term data and comparative studies will be needed to confirm durability and broader applicability.

Source:

Shishehbor, M. H. (2026). PROMISE III: 6-month clinical and quality of life outcomes in CLTI patients treated with transcatheter arterialization of the deep veins. SCAI 2026 Scientific Sessions. Montreal. April 23, 2026. https://scai.confex.com/scai/2026/meetingapp.cgi/Paper/45999