Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions (ORBIT II)
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|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||Phase|
|Coronary Artery Disease||Device: Diamondback 360 Orbital Atherectomy System||Not Applicable|
|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|
|Actual Primary Completion Date :||January 2013|
|Actual 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.
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): NCT01092416
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|Principal Investigator:||Jeffrey Chambers, MD||Metropolitan Cardiology Consutants|