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Abbott Next Generation Drug Eluting Stent 48mm Study — SPIRIT 48  

Coronary Artery Disease Clinical Trial

Official title:
A Clinical Investigation to Assess the Abbott Next Generation Drug Eluting Stent 48mm Everolimus Eluting Coronary Stent System (EECSS) in Treatment of de Novo Native Coronary Artery Disease

Clinical Trial Summary

The purpose of this SPIRIT 48 study is to evaluate the safety and effectiveness of the ABT NG DES 48 in improving coronary artery luminal diameter in subjects with coronary artery disease (CAD) due to de novo native coronary artery long lesions.

Clinical Trial Description

The SPIRIT 48 mm study is a prospective, single arm, open-label, multi-center global (US and outside of US) clinical investigation to evaluate the safety and effectiveness of the ABT Next Generation Drug Eluting Stent 48 mm everolimus-eluting coronary stent system (EECSS) (called "ABT NG DES 48") in up to 107 subjects at up to 33 sites globally. The clinical outcomes from the SPIRIT 48 study will be compared to a performance goal (PG) established using historical control data from the SPIRIT Prime Long Lesion Registry. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the ABT NG DES 48 in the United States. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04282148
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase N/A
Start date June 17, 2020
Completion date September 17, 2023
View Details
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