Clinical Trial of the Week: Treatment trial for patients diagnosed with atherosclerosis in a leg

By Donna Loyle, communications specialist, LIMR

Researchers seek patients who’ve been diagnosed with severe claudication or critical ischemia to a lower limb for a randomized study to determine the appropriate dosage of the FDA-approved medication Torisel® (temsirolimus).

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 or tibial/peroneal vessels.

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).

 

Inclusion criteria:

  • 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 and procedural anticoagulation therapy 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.

The principal investigator for trial #CIP0214 (TANGO) is Antonis Pratsos, MD. The trial is approved for Bryn Mawr Hospital. For more, click here: https://www.mainlinehealth.org/research/clinical-trials/cip0214-tango

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