Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-30 @ 4:22 PM
Study NCT ID:
NCT04562532
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-24
First Post:
2020-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Firehawk Rapamycin Target Eluting Coronary Stent North American Trial
Sponsor:
Shanghai MicroPort Medical (Group) Co., Ltd.
Organization:
Study Overview
Official Title:
Multicenter Randomized Assessment of the Firehawk™ Rapamycin TARGET Eluting Cobalt Chromium Coronary Stent System - North American Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TARGET-IV_NA
Brief 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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: