Abbott Next Generation Drug Eluting Stent 48mm Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 100
Summary
- Conditions
- Coronary (Artery) Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Prospective, multi-center, global (US and OUS)Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04282148
- Collaborators
- Not Provided
- Investigators
- Study Director: Jessie Coe Abbott Principal Investigator: Ki E Park, MD University of Florida/Malcom Randall VAMC Principal Investigator: Chi-Jen Chang, MD Chang Gung Memorial Hospital
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