TAP-DANCE: Temsirolimus Alone or Paired with Dexamethasone delivered to the Adventitia to eNhance Clinical Efficacy after femoropopliteal revascularization
TAP-DANCE: Temsirolimus Alone or Paired with Dexamethasone After Femoropopliteal Revascularization (Femoral Artery Disease Procedure)
Sponsor: Mercator MedSystems, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAS6563
U.S. Govt. ID: NCT03942601
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information: This study is to test if a combination drug/device therapy using TEMSIROLIMUS (Temsirolimus Injection), with or without the generic steroid DEXAMETHASONE (Dexamethasone Sodium Phosphate Injection), can be delivered safely into the tissue around the blood vessel wall at the time of an angioplasty ( which is a a procedure to open blocked arteries and restore blood flow) and whether that delivery helps to prevent re-narrowing of the blood vessel. If you are 18 and have a narrowing or blockage of the blood vessels (arteries) in your leg which your physician has determined needs to be treated with either an angioplasty procedure to improve the blood flow in your leg, you may be eligible for this study if you. You will need to have exams, tests or procedures to find out if you indeed are eligible for the study.Participation in the study will add about 2.5 hours over a 2 year period to your standard of care. There will be scheduled follow-ups and phone interview calls.
This study is closed
Investigator
Sahil Parikh, MD
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Are you 18 years of age or older? Yes No
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For more information, please contact:
Kate Dalton
keb2114@cumc.columbia.edu
347-514-3366