NCT04150016

In-stent Repair and Vessel Reaction of STEMI Patients With OCT

Assessment of In-stent Intimal Repair and Vessel Reaction After FirehawkTM Sirolimus Eluting Stent Implantation of STEMI Subjects - An Optical Coherence Tomography (OCT) Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multi-center, non-inferior, randomized controlled clinical trial, aims to use optical Coherence tomography to observe the the early- and mid-stage vessel repair and neointimal proliferation. And 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 ST-elevation myocardial infarction (STEMI).

Conditions

• Drug-eluting Stents
• Percutaneous Coronary Intervention
• Optical Coherence Tomography
• ST-Elevation Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	percutaneous coronary intervention	Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is a nonsurgical procedure that improves blood flow to your heart.PCI requires cardiac catheterization, which is the insertion of a catheter tube and injection of contrast dye, usually iodine-based, into your coronary arteries. Doctors use PCI to open coronary arteries that are narrowed or blocked by the buildup of atherosclerotic plaque. PCI may be used to relieve symptoms of coronary heart disease or to reduce heart damage during or after a heart attack.

Timeline

• Start date: 2019-03-08
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2019-11-04
• Last updated: 2019-11-04

Locations

1 site across 1 country: China