TANGO: Temsirolimus Adventitial Delivery to Improve ANGiographic Outcomes Below the Knee
This is a prospective, multi-center, randomized, dose escalation study to document the effects of adventitial delivery of temsirolimus (Torisel) after revascularization of lesions below the knee in symptomatic patients with critical limb ischemia (CLI).
The purpose of this study is to test if a combination drug/device therapy utilizing TORISEL (temsirolimus), which can be delivered safely into the tissue around the blood vessel wall at the time of an angioplasty or atherectomy and whether that delivery helps to prevent re-narrowing of the blood vessel. Although TORISEL is approved by the FDA for intravenous delivery (also called IV, a common way to give medicine), it has not been approved by the FDA for a variety of anti-inflammatory or anti-proliferative indications, and it has not been approved for local tissue delivery to treat inflammation of blood vessels that might be caused by endovascular procedures, therefore its use in this study is experimental. We want to find out if this procedure helps prevent re-narrowing of the blood vessel after angioplasty or atherectomy. The combination drug/device therapy includes the drug, TORISEL, which is already FDA-approved for other uses but is not yet approved for treating blood vessels, and the device, the Bullfrog® Micro-Infusion Device, which is an FDA-cleared device for infusing medications into tissues around the blood vessel. The Bullfrog® Micro-Infusion Device is similar to other balloon tipped catheters except that it contains a microneedle covered by a folded balloon. Once the balloon is inflated, the microneedle is uncovered and a medication can be delivered into the tissue around the blood vessel.
Age 18-90 years old
Chronic Limb Ischemia of the popliteal artery to the ankle joint with Rutherford 3, 4 or 5
Patients on immunotherapy, chemotherapy or steroids.
Recent (< 30 days) myocardial infraction
Recent (< 60 days) cerebrovascular accident