The Safety and Effectiveness Evaluation of New Specifications (2.25mm) of FirehawkTM Sirolimus Target-eluting Coronary Stent System in the Treatment of Coronary Heart Disease: a Prospective, Multicenter, Single-group Study.

Shanghai MicroPort Medical (Group) Co., Ltd.1 site in 1 country38 target enrollmentMay 2014

ConditionsCoronary Heart Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Heart Disease
Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
Enrollment: 38
Locations: 1
Primary Endpoint: In-stent Late Loss
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evalute the clinical safety and effectiveness of released specification (2.25mm) of FirehawkTM Sirolimus target-eluting coronary stent system.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

December 2020

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai MicroPort Medical (Group) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18-80 years of age, males or non-pregnant women;
•Evidence of silent ischemia, stability or in patients with old myocardial infarction or unstable angina;
•Primary target lesion, in situ coronary artery disease;
•Target lesion length ≤ 60mm, target lesion diameter 2.25mm (Visual method);
•The target lesion diameter stenosis ≥ 70% (Visual method);
•Each target lesion implantation the same stent (Firehawk stent);
•With indications for coronary artery bypass surgery;
•To understand the purpose of testing, voluntary and informed consent, patients agreed to achieve invasive imaging and clinical follow-up.

Exclusion Criteria

•Within 72h of any acute myocardial infarction;
•Unprotected left main coronary artery disease, triple vessel lesions which need treated all; bifurcation lesions and vascular lesions of the bridge;
•Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;
•Artery and/or vein bypass graft lesions;
•Intracoronary implantation of any branding stents within 1 year;
•Severe congestive heart failure (NYHA class III and above), or left ventricular ejection fraction \<35% (ultrasound or left ventricular angiography);
•Preoperative renal function serum creatinine \>2.0mg/DL;
•Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy;
•Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
•The patient's life expectancy is less than 12 months;

Outcomes

Primary Outcomes

In-stent Late Loss

Time Frame: 9 month after stent implantation

the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure.