Evaluation of New Specifications (2.25mm) of FirehawkTM in the Treatment of Coronary Heart Disease ( Firehawk_2.25 )

NCT02688868 | Completed Results DMC

• 1 other identifier: Firehawk_SS
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• In-stent Late Loss

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

  9 month after stent implantation

Secondary Outcomes (8)

• Number of Participants With Target Lesion Failure

  12 months

• Number of Participants With Target Lesion Failure

  2 years

• Number of Participants With Target Lesion Failure

  3 years

• Number of Participants With Target Lesion Failure

  4 years

• Number of Participants With MACE

  12 months

Study Arms (1)

new specifications (Diameter 2.25mm)of Firehawk stent

EXPERIMENTAL

Evaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease

Device: FirehawkTM 2.25mm

Interventions

FirehawkTM 2.25mm DEVICE

Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems

new specifications (Diameter 2.25mm)of Firehawk stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
• Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
• Heart transplantation patients.

Sponsors & Collaborators

• Shanghai MicroPort Medical (Group) Co., Ltd.: lead

Study Sites (1)

Fu Wai Hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: HT Zhang
• Organization: Shanghai Microport Medicine

zhanght@microport.com

+862138954600

Study Officials

• Runlin Gao, MD

  Fu Wai Hospital & National Center for Cardiovascular Diseases in China

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 23, 2016
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2020
• Last Updated: October 23, 2023
• Results First Posted: February 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)