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ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.

Coronary Artery Disease Clinical Trial

Official title:
ABSORB FIRST Registry: An International Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb Bioresorbable Vascular Scaffold (Absorb BVS).

Clinical Trial Summary

ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to:

- Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily PCI practice per Instructions for Use (IFU, on-label use).

- To evaluate the safety and performance of 12 mm or shorter Absorb BVS in single or overlapping use (bailout, optimization of long lesion treatment) for the treatment of patients with ischemic heart disease caused by de novo native coronary artery lesion(s)

- 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.

Clinical Trial Description

the ABSORB FIRST Registry is intended to provide an assessment of the safety and performance of the Absorb BVS device in accordance to the IFU in real world use involving more complex patients, lesions and use (examples: longer lesions, overlapping use, bailout, patients at high risks for cardiac events, etc.).

The ABSORB FIRST study will register a minimum of 1800 patients in approximately 90 sites throughout multiple countries worldwide where Absorb BVS has regulatory approval or is commercially available. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01759290
Study type Observational [Patient Registry]
Source Abbott Vascular
Contact
Status Completed
Phase N/A
Start date January 2013
Completion date December 2015
View Details
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