Ignite Creation Date:
2024-05-05 @ 10:22 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01092416
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2010-03-23
Brief Title:
Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORBIT II
Brief Summary:
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 US 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None