NCT04562532

Firehawk Rapamycin Target Eluting Coronary Stent North American Trial

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,720 (estimated)
• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-02-17
• Primary completion: 2023-12-10
• Completion: 2027-06-30
• First posted: 2020-09-24
• Last updated: 2024-07-24

Locations

57 sites across 5 countries: United States, Belgium, Canada, Denmark, Netherlands

Regulatory

• FDA-regulated device study