Coronary Orbital Atherectomy System Study (COAST)
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|ClinicalTrials.gov Identifier: NCT02132611|
Recruitment Status : Completed
First Posted : May 7, 2014
Results First Posted : October 27, 2016
Last Update Posted : July 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|CAD||Device: Diamondback 360® Coronary OAS Micro Crown||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Coronary Orbital Atherectomy System Study|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||June 2017|
Experimental: Diamondback 360® Coronary OAS Micro Crown
Diamondback 360® Coronary Orbital Atherectomy System Micro Crown
Device: Diamondback 360® Coronary OAS Micro Crown
The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
- Major Adverse Cardiac Event (MACE) [ Time Frame: 30 Days ]
A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 30 days.
30-Day MACE is composed of:
- Cardiac death
- Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave
- Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure
- Procedural Success [ Time Frame: Participants were followed from baseline procedure through the duration of hospital stay, an average of 50.4 hours ]Procedural success was defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02132611
|Principal Investigator:||Gregg Stone, MD||Columbia University|