The First-In-Man Pilot Study of Firehawk

NCT02688829 | Completed Results DMC

• 1 other identifier: Firehawk_FIM
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a small-scale pilot clinical study of the Rapamycin-Eluting Coronary Stent System of Microport for the first time to assess the preliminary safety and feasibility used in the human body. And provide evidence for subsequent large-scale, multi-center, randomized controlled clinical trials, then provide the basis for the formal application of the product in China.

Conditions

Coronary Heart Disease

Keywords

Sirolimus eluting stents; percutaneous coronary intervention; First in man

Outcome Measures

Primary Outcomes (1)

• Count of Participants With MACE (Major Acute Cardiovascular Events)

  Count of Participants who have major acute cardiovascular events (MACE) in 1 month follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.

  1 month after stent implantation

Secondary Outcomes (6)

• In-stent Late Lumen Loss

  4 months after stent implantation

• Count of Participants With MACE (Major Acute Cardiovascular Events)

  4 month after stent implantation

• Percentage of In-stent Diameter Stenosis

  4 months after stent implantation

• In-stent Late Lumen Loss

  13 month after stent implantation

• Count of Participants With MACE (Major Acute Cardiovascular Events)

  13 month after stent implantation

Study Arms (1)

treatment group

EXPERIMENTAL

Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease.

Device: Rapamycin target-eluting Coronary Stent System

Interventions

Rapamycin target-eluting Coronary Stent System DEVICE

Implantation of the rapamycin-eluting coronary stent system

Also known as: Firehawk

treatment group

Eligibility Criteria

• Age: 18 Years - 75 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 females;
• With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;
• Total number of target lesion is 1;
• Target lesion length ≤ 30mm (Visual); target lesion diameter between 2.25mm to 4.0mm;
• Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1;
• Each target lesion may be covered by a single stent;
• Patients with indications for coronary artery bypass graft surgery;
• To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.

You may not qualify if:

• Within 1 month of any acute myocardial infarction;
• Chronic total occlusion (TIMI grade 0 flow before surgery), left main coronary artery disease, mouth lesions, multiple-vessel lesions, branch diameter ≥ 2.5mm bifurcation lesions and vascular lesions of the bridge;
• Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;
• In-stent Restenosis lesions;
• Intracoronary implantation of any branding stents within 1 year;
• Severe congestive heart failure (NYHA class III and above) ,left ventricular ejection fraction or \<40% (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

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr Zhang Haotian
• Organization: Microport Medical, Shanghai, China

zhanght@microport.com

8621-38954600

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

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 23, 2016
• Study Start: December 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2015
• Last Updated: October 17, 2019
• Results First Posted: October 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share