Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions (ORBIT II)
|ClinicalTrials.gov Identifier: NCT01092416|
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : January 6, 2016
Last Update Posted : March 9, 2017
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Device: Diamondback 360 Orbital Atherectomy System|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||443 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360°® Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II)|
|Study Start Date :||May 2010|
|Primary Completion Date :||January 2013|
|Study Completion Date :||January 2016|
Device: Diamondback 360 Orbital Atherectomy System
- Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE) [ Time Frame: 30 days ]
OAS safety was measured by a composite of MACE at 30-days post procedure. MACE is composed of:
- Cardiac death.
- MI - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave.
- TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure.
- Primary Efficacy Endpoint: Procedural Success [ Time Frame: Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 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.
- Angiographic Success [ Time Frame: Baseline procedure, with a mean total procedure time of 52.5 minutes. ]Angiographic success was defined as success in facilitating stent delivery with <50% residual stenosis and without severe angiographic complications.
- Severe Angiographic Complications [ Time Frame: Baseline procedure, with a mean total procedure time of 52.5 minutes. ]Severe angiographic complications were defined as severe dissection (Type C to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
- 12-Month Freedom From Major Adverse Cardiac Events (MACE) [ Time Frame: 12 months ]The safety of the OAS was measured for the secondary safety endpoint consisting of a composite of freedom from MACE through 12 months of follow-up.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092416
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|Principal Investigator:||Jeffrey Chambers, MD||Metropolitan Cardiology Consutants|