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Firehawk Rapamycin Target Eluting Coronary Stent North American Trial

NCT04562532 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1720

Last updated 2024-07-24

No results posted yet for this study

Summary

The aim of the TARGET-IV NA trial is to demonstrate the clinical non-inferiority of the Firehawk® rapamycin eluting stent system in comparison to currently approved 2nd generation DES for the treatment of subjects with ischemic heart disease (NSTEMI, recent STEMI (\>24 hours from initial presentation and in whom enzyme levels have peaked), unstable angina, and stable coronary disease), with atherosclerotic target lesion(s) in coronary arteries with visually estimated reference vessel diameters ≥2.25 mm and ≤4.0 mm.

Conditions

Interventions

DEVICE

Microport Firehawk stent

MicroPort Firehawk biodegradable polymer rapamycin target eluting stent

DEVICE

2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent)

* Everolimus eluting stents (Xience family - Abbott Vascular, Promus family- Boston Scientific, Synergy - Boston Scientific) * Zotarolimus eluting stents (Resolute/Onyx family and Endeavor- Medtronic) * Sirolimus eluting stents (Orsiro- Biotronik)

Sponsors & Collaborators

  • Shanghai MicroPort Medical (Group) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Martin Leon · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-17
Primary Completion
2023-12-10
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Denmark
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT04562532 on ClinicalTrials.gov