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

Xijing Hospital1 site in 1 country44 target enrollmentMarch 8, 2019

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Drug-eluting Stents
Sponsor: Xijing Hospital
Enrollment: 44
Locations: 1
Primary Endpoint: Neointimal thickness by OCT
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

March 8, 2019

End Date

December 1, 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Xijing Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must be 18 - 75 years of age; male or female without pregnancy.
•Subjects recently suffer from SETMI (from 20 minute to 12 hours), and ECG changes consistent with AMI:
•1mm elevation in more than 2 continuously leads, or; Newly developed LBBB, or;
•1mm depression in more than 2 continuously leads representing Posterior myocardial infarction) CI
•New, in situ and single or bifurcation lesion of target vessel. CI
•Subject only implanted one brand of stent. CI
•Subjects are eligible candidates for coronary artery bypass graft surgery (CABG).
•Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed;
•Angiographic Inclusion Criteria:
•At least one of the target lesions must be acute occlusion lesion, and Eligible for percutaneous coronary intervention (PCI), and Having a visually estimated diameter restenosis no less than 70% (or a visually estimated diameter restenosis no less than 50% with consistent clinical symptoms), TIMI blood flow no less than Grade I, and have a visually estimated reference diameter ≥2.25 mm and ≤4.0 mm.

Exclusion Criteria

•Subjects with Cardiogenic shock. CE
•Subjects with severe heart failure (NYHA classification ≥ 3) or LVEF\<35%. CE
•Subjects with elevated serum creatinine level \>2.0mg/dL or undergoing dialysis therapy.
•Subjects associated with drugs allergy (such as sirolimus, everolimus, stent alloys, contrast medium, heparin, clopidogrel or aspirin).
•Subjects with bleeding tendency, active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion.
•Subjects with cardiac stroke or with sequelae of stroke. CE
•Subjects with cebral tumor, Cerebral aneurysms, cerebral arteriovenous malformation (AVM), transient ischemic attack (TIA), permanent nerve defects, GI bleeding within 2 months, major operation within 6 weeks, or with abnormal counts of platelet and hemoglobin (Hb): platelet counts less than 1×106/mm3, Hb less than 10g/dL.
•Subjects plan to undergo any operations within 6 months that may lead to anti-platelet therapy discontinuation.
•Subjects are suffering from other serious illness, which may cause drop in life expectancy to less than 12 months.
•Subjects were participating in another study of drug or medical device, which did not meet its primary endpoint.

Outcomes

Primary Outcomes

Neointimal thickness by OCT

Time Frame: At 6 months post-index procedure

Secondary Outcomes

Thrombosis (from ARC definition)(30 days, 6 months, 12 months post-index procedure)
Percentage of Uncovered Struts by OCT(At 6 months post-index procedure)
Target lesion failure(30 days, 6 months, 12 months post-index procedure)
In-stent and in-segment late lumen loss(At 6 months post-index procedure)
Percentage of Malaposition Struts by OCT(At 6 months post-index procedure)