Abbott Next Generation Drug Eluting Stent 48mm Study

NCT04282148 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2025-01-08

Study results available
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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.

Conditions

Interventions

DEVICE

ABT NG DES 48 EECSS

Each participant will receive ABT NG DES 48 EECSS with appropriate diameter

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Chi-Jen Chang, MD · Chang Gung Memorial Hospital

  • Ki E Park, MD · University of Florida/Malcom Randall VAMC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-17
Primary Completion
2022-10-05
Completion
2023-09-17
FDA Device
Yes

Countries

  • United States
  • Australia
  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04282148 on ClinicalTrials.gov