Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT01977534
Status:
COMPLETED
Last Update Posted:
2018-12-17
First Post:
2013-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Study the Safety and Clinical Outcomes of the Absorb Bioresorbable Vascular Scaffold (BVS) System in Patients With de Novo Lesions in Previously Untreated Vessels
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
A Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb BVS
Status:
COMPLETED
Status Verified Date:
2018-12
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 UK
Brief Summary:
The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.
Detailed Description:
ABSORB UK registry is a prospective, single arm, post-market registry designed to:
* Provide ongoing post-market surveillance for documentation of safety and clinical outcomes of the Absorb Everolimus Eluting BVS System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use).
* Collect additional information (e.g. acute success) to evaluate handling and implantation of Absorb BVS by physicians under a wide range of commercial use conditions and following routine clinical practice.
* Provide ongoing post-market surveillance for documentation of safety and clinical outcomes of the Absorb Everolimus Eluting BVS System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use).
* Collect additional information (e.g. acute success) to evaluate handling and implantation of Absorb BVS by physicians under a wide range of commercial use conditions and following routine clinical practice.
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?: