NCT04282148

Abbott Next Generation Drug Eluting Stent 48mm Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	ABT NG DES 48 EECSS	Each participant will receive ABT NG DES 48 EECSS with appropriate diameter

Timeline

• Start date: 2020-06-17
• Primary completion: 2022-10-05
• Completion: 2023-09-17
• First posted: 2020-02-24
• Last updated: 2025-01-08
• Results posted: 2024-02-12

Locations

25 sites across 3 countries: United States, Australia, Taiwan

Regulatory

• FDA-regulated device study