NCT03040934

Firehawk™ Coronary Stent System in the Treatment of Coronary Chronic Total Occlusion Lesion(s)

A Prospective, Open Label, Multi-center Trial of Firehawk™ Coronary Stent System in the Treatment of Coronary Chronic Total Occlusion Lesion(s) by Optical Coherent Tomography (OCT) and Coronary Angiography

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multi-center, open-label, randomized controlled clinical trial,aims to assess the safety and effectiveness of the Firehawk™ sirolimus target-eluting coronary stent system with abluminal grooves containing a biodegradable polymer (Firehawk™) comparing the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with total coronary occlusion lesion(s).

Detailed description

This study will recruit 196 subjects with total coronary occlusion lesion(s) in coronary arteries ≥2.25 mm to ≤4.0 mm in diameter and ≤100 mm in length (by visual estimate) in no more than 10 research centers in China. All participants met the inclusion criteria will be 1:1 randomized to receive Firehawk™ sirolimus target-eluting coronary stent or XIENCE everolimus-eluting coronary stent. Optical Coherent Tomography (OCT) sub study: the first 44 consecutive subjects who consented to participate in the OCT sub study will undergo OCT assessment at 3 months and 12 months post index procedure. The OCT sub study will be performed in 3-5 pre-selected sites. The clinical follow-up will be carried out at 30 days, 3 months, 6 months, 12 months,and 2-5 years post-index procedure.The primary endpoint is in-stent late lumen loss at 12 months post-index procedure.The secondary endpoint is neo-intimal thickness by Optical Coherent Tomography (OCT) at 3 months post-index procedure.

Conditions

• Drug-Eluting Stents
• Percutaneous Coronary Intervention
• Tomography, Optical Coherence

Interventions

Type	Name	Description
DEVICE	Firehawk sirolimus target eluting coronary stent system	98 subjects will be enrolled to receive a test device of Firehawk sirolimus target eluting coronary stent system
DEVICE	XIENCE Everolimus-Eluting Coronary Stent System	98 subjects will be enrolled to receive a control device of XIENCE Everolimus-Eluting Coronary Stent System

Timeline

• Start date: 2017-11-10
• Primary completion: 2019-09-16
• Completion: 2023-10-01
• First posted: 2017-02-02
• Last updated: 2020-01-10

Locations

1 site across 1 country: China