Clinical Trial: Firehawk™ Coronary Stent System in the Treatment of Total Coronary Artery Occlusion Lesion(s)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Prospective, Open Label, Multi-center Trial of Firehawk™ Coronary Stent System in the Treatment of Total Coronary Artery Occlusion Lesion(s) by Optical Coherent To

Brief 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 Summary:

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.

Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.

Current Primary Outcome: In-stent late lumen loss [ Time Frame: At 12 months post-index procedure ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Neo-intimal thickness by Optical Coherence Tomography (OCT) [ Time Frame: At 3 months post-index procedure ]

Original Secondary Outcome: Same as current

Information By: Shanghai MicroPort Medical (Group) Co., Ltd.

Dates:
Date Received: January 25, 2017
Date Started: July 2017
Date Completion: December 2023
Last Updated: February 1, 2017
Last Verified: January 2017