Study ID: CIP0214 TANGO
TANGO: Temsirolimus adventitial delivery to improve angiographic outcomes below the knee
This randomized study is to determine the appropriate dosage of the FDA-approved drug Torisel® (temsirolimus) in patients diagnosed with severe claudication (cramping leg pain induced by exercise and typically caused by obstruction of the arteries) or critical ischemia (inadequate blood supply) to a lower leg.
Eligible patients are randomized into three study groups. One group receives a low dose of the medication; one group receives a higher dose; and the third group is the control cohort (receives normal saline).
This is a prospective, multi-center, randomized, dose escalation study to document the effects of adventitial delivery of temsirolimus after revascularization of lesions below the knee in symptomatic patients with severe claudication or critical limb ischemia. Subjects are followed for up to 12 months post index procedure.
The research objective is to assess the safety and effectiveness of Bullfrog Micro-Infusion Device adventitial deposition of temsirolimus in reducing intimal hyperplasia, inflammatory markers and composite safety endpoints after revascularization of one or more angiographically significant lesion(s) in below-knee popliteal (P3) or tibial/peroneal vessels.
Eligible patients must have been diagnosed with single or multiple obstructive atherosclerotic lesion(s) with ≥70% diameter stenosis in at least one P3 or tibial/peroneal target vessel that totals up to 25 cm in length with no greater than 5 cm length of contiguous intervening normal artery, and with a target vessel diameter of ≥2 mm and ≤8 mm.
Enrolled patients will be randomized 2:1 as follows:
- Control group: Saline/contrast (80% normal saline for injection; 20% non-ionic contrast medium)
- Low-dose group: 0.1 mg/mL temsirolimus (including 20% contrast)
- High-dose group: 0.4 mg/mL temsirolimus (including 20% contrast)
- Must have been diagnosed with severe claudication (Rutherford 3) or chronic critical limb ischemia (Rutherford 4-5) in the target limb due to arterial stenosis between the knee joint space and the ankle joint
- Must not be receiving chronic anticoagulation therapy, such as warfarin. Chronic antiplatelet therapy (e.g., aspirin, clopidogrel), and procedural anticoagulation therapy (e.g., heparin, bivalirudin) are permitted
- Must not be receiving or planned to receive systemic immunotherapy, chemotherapy or corticosteroids; inhaled corticosteroids for asthma treatment or topical steroid uses are permitted
- Must meet angiographic study lesion specifications