A new analysis of the PROMISE III trial shows significant quality-of-life improvements for patients with "no-option" chronic limb-threatening ischemia (CLTI) following a novel deep vein arterialization procedure.
PROMISE III Trial: Quality-of-Life Gains Confirmed for No-Option CLTI Patients
A secondary analysis of the prospective, multicenter, single-arm PROMISE III trial has provided new evidence that the LimFlow System for transcatheter arterialization of the deep veins (TADV) not only saves limbs but also substantially improves patient quality of life. The data was presented at SCAI 2026.
The primary endpoint of the study, amputation-free survival, was previously reported at 80.7% at six months. The latest analysis focused on patient-reported outcomes using the VascuQoL-6 survey, which measures the impact of poor circulation on daily life.
A Clear Shift in Patient Well-Being
Six months post-procedure, patients reported dramatic reductions in the burden of their condition across multiple domains compared to baseline:
- Concern about poor circulation: Decreased from 90% to 45%.
- Ability to participate in social activities: The proportion reporting difficulty dropped from 72% to 40%.
- Trouble sleeping: Declined from 85% to 40%.
- Daily toll of a foot wound: Decreased from 79% to 39%.
"The findings suggest TADV is a promising option for no-option CLTI patients." — Lead researcher Mehdi H. Shishehbor
Looking Ahead
While the results are encouraging, researchers see room for advancement. Future studies will focus on optimizing the stent, reducing procedure time, and refining patient selection criteria to maximize outcomes for this critically ill population.