Evaluation of New Specifications (38mm) of FirehawkTM in the Treatment of Coronary Heart Disease

NCT02688842 | Completed Results DMC

• 1 other identifier: Firehawk_LS
• 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 (38mm) of FirehawkTM Sirolimus target-eluting coronary stent system.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• In-stent Late Lumen Loss

  9 month after stent implantation

Secondary Outcomes (12)

• Participants With Target Lesion Failure

  30 days after stent implantation

• Participants With Target Lesion Failure

  6months after stent implantation

• Participants With Target Lesion Failure

  12 months after stent implantation

• Participants With Target Lesion Failure

  2 years after stent implantation

• Participants With Target Lesion Failure

  3 years after stent implantation

Study Arms (1)

treatment group

EXPERIMENTAL

Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems

Device: Rapamycin target-eluting coronary stent systems (38mm)

Interventions

Rapamycin target-eluting coronary stent systems (38mm) DEVICE

Also known as: Firehawk-38

treatment group

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 2.75mm or 4.0mm (Visual method);
• The target lesion diameter stenosis ≥ 70% (Visual method);
• Each target lesion implantation the same stent (Firehawk stand);
• With indications for coronary artery bypass surgery;
• To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging 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;
• 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: Haotian Zhang
• Organization: Shanghai Microport Medical (Company) Co.,Ltd.

zhanght@microport.com

+86-21-38954600

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: No

Study Design

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

Model Details: all patients implanted Firehawk stent of new specification (38mm long)

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 23, 2016
• Study Start: May 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2021
• Last Updated: October 23, 2023
• Results First Posted: February 20, 2020

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)