Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions (ORBIT II)
This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the OAS in treating de novo, severely calcified coronary lesions in adult subjects. Study is going to enroll up to 429 subjects in up to 50 U.S. study sites. The primary safety endpoint is 30-day MACE and primary efficacy endpoint is procedural success. All subjects will be treated with the orbital atherectomy system and adjunctive stent. All subjects will be followed in clinic at 30 days. Additionally, all subjects will have an annual phone call or clinical follow up at each anniversary until study is closed.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Major Adverse Cardic Event (MACE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
30-day 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.
- Angiographic Success [ Time Frame: Preodecure ] [ Designated as safety issue: No ]Angiographic success is defined as success in facilitating stent delivery with <50% residual stenosis and without serious angiographic complications.
- Severe Angiographic Complications [ Time Frame: Procedure ] [ Designated as safety issue: Yes ]Severe angiographic complications are defined as severe dissection (Type C to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
- 12-Month MACE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]See MACE definition in the primary outcome
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||January 2016|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Device: Diamondback 360 Orbital Atherecotmy System
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092416
Show 51 Study Locations
|Principal Investigator:||Jeffrey Chambers, MD||Metropolitan Cardiology Consutants|