102
Participants
Start Date
June 1, 2016
Primary Completion Date
June 16, 2020
Study Completion Date
June 16, 2020
Medtronic HawkOne® or TurboHawk™
Use of FDA Cleared Directional Atherectomy (DA) Devices. Medtronic HawkOne® Directional Atherectomy System or TurboHawk™ Plaque Excision System. DA followed by DCB will be performed in all enrolled subjects.
Medtronic IN.PACT® Admiral® DCB
FDA Approved Drug Coated Balloon (DCB) Technology. Medtronic IN.PACT® Admiral® DCB will be used after DA.
Medtronic Spider™ Distal Protection Device (DPD)
It is recommended that the Medtronic Spider™ Distal protection device (DPD) be paired with DA when used in complex, calcified lesions (TurboHawk™ IFU).
"Volcano Visions® PV .014 IVUS catheter"
"Lesion IVUS assessment using the Volcano Visions® PV .014 IVUS catheter will be required in all cases."
Nitinol Stent Placement
Only FDA approved nitinol stents can be used if provisional stenting is required.
St. Elizabeth's, Boston
Mount Sinai, New York
Rex, Raleigh
University of Mississippi, Jackson
Iowa Methodist Medical Center, Des Moines
Longview Cardiac and Vascular Consultants, Longview
Austin Heart, Austin
Collaborators (1)
Medtronic
INDUSTRY
VIVA Physicians
OTHER