Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-02 @ 7:11 AM
Study NCT ID:
NCT00856856
Status:
COMPLETED
Last Update Posted:
2019-02-07
First Post:
2009-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ABSORB Clinical Investigation, Cohort B
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With de Novo Native Coronary Artery Lesions.
Status:
COMPLETED
Status Verified Date:
2018-01
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:
ABSORB B
Brief Summary:
The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels.
Currently in development at Abbott Vascular. Not available for sale in the United States.
Currently in development at Abbott Vascular. Not available for sale in the United States.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: