Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

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.

Official Title

Multicenter Randomized Assessment of the Firehawk™ Rapamycin TARGET Eluting Cobalt Chromium Coronary Stent System - North American Trial

Details

TARGET-IV NA trial is a prospective, multicenter, 1:1 randomized (Firehawk® vs. 2nd generation DES), trial.

Sub studies:

Angiographic sub study: The first approximately 200 consecutive consenting patients will be enrolled in the angiographic substudy. Optical coherence tomography (OCT) substudy: The first approximately 50 consecutive consenting subjects will be enrolled in the OCT substudy.

Clinical follow-up will be performed at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post randomization. First approximately 200 consecutive consenting patients will undergo planned angiographic follow-up at 13 months after enrollment, with first 50 of these patients also consented to undergo planned OCT at baseline and at 13 months following randomization.

Keywords

Coronary Artery Disease, Sirolimus, Microport Firehawk stent, 2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent)

Eligibility

Locations

  • UC San Diego School of Medicine
    La Jolla California 90903 United States
  • Sharp Memorial Hospital
    San Diego California 92123 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Shanghai MicroPort Medical (Group) Co., Ltd.
ID
NCT04562532
Study Type
Interventional
Participants
Expecting 1720 study participants
Last Updated