Condition: Peripheral Artery Disease · Critical Limb Ischemia · Sponsor: Mercator MedSystems, Inc.
A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of Temsirolimus Perivascular Injection 0.1 mg/mL on the incidence of ischemia-driven major amputation, clinically driven target lesion revascularization, and clinically relevant target lesion occlusion after revascularization of lesions below the knee in patients with symptomatic Rutherford 3-5 peripheral artery disease. The primary safety endpoint will be gathered at 1-month post-index procedure. The primary efficacy endpoint will be gathered at 6 months post-index procedure. Participants will be followed for up to 5 years post-index procedure.
This description comes directly from the study's public registry record.
Kirk Seward, PhD · (510) 614-4555 · kseward@mercatormed.com
Always discuss trial participation with your own doctor first.
| Cardiovascular Institute of the South | Houma, Louisiana, United States | Recruiting |
| UT Southwestern | Dallas, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04433572