At Cleveland Medical Center, clinicians have demonstrated that a minimally invasive approach can spare many patients with severe leg circulation problems from losing a limb. The findings were published in a leading medical journal.
In the PROMISE II clinical trial, researchers assessed how well LimFlow transcatheter deep vein arterialization works to restore blood flow to the legs. The goal of this procedure is to reestablish effective circulation in areas where traditional pathways have failed.
The trial enrolled 105 participants diagnosed with end-stage peripheral arterial disease. In these cases, reduced blood flow to a limb caused numbness, weak or absent pulses in the feet or legs, and occasionally open or nonhealing wounds with a risk of infection. At the outset, amputation was advised for all patients as a potential solution to relieve pain and prevent further complications.
Six months after the intervention, a substantial proportion of patients avoided amputation, with results showing around three-quarters of participants maintaining their limb. Many experienced complete healing of wounds during this period, while the six‑month mortality rate remained in line with expectations for patients facing severe limb threat, comparable to or lower than the rate associated with amputation. These outcomes underscore limb‑salvage potential for individuals with extensive circulatory compromise when traditional methods would otherwise leave them with fewer options.
Overall, the study highlights a strategy that aims to reverse critical ischemia by constructing a new avenue for arterial blood to reach the leg tissue. By reestablishing perfusion through a novel venous-to-arterial pathway, the approach seeks to reduce pain, promote tissue repair, and improve function. As with any emerging therapy, continued research, careful patient selection, and long‑term follow‑up are essential to fully understand durability, complication risks, and the role this procedure may play within the broader spectrum of limb-sparing treatments.