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Evaluation of New Specifications (38mm) of FirehawkTM in the Treatment of Coronary Heart Disease (Firehawk_38)

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rapamycin target-eluting coronary stent systems (38mm)
Sponsored by
Shanghai MicroPort Medical (Group) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18-80 years of age, males or non-pregnant women;
  2. Evidence of silent ischemia, stability or in patients with old myocardial infarction or unstable angina;
  3. Primary target lesion, in situ coronary artery disease;
  4. Target lesion length ≤ 60mm, target lesion diameter 2.75mm or 4.0mm (Visual method);
  5. The target lesion diameter stenosis ≥ 70% (Visual method);
  6. Each target lesion implantation the same stent (Firehawk stand);
  7. With indications for coronary artery bypass surgery;
  8. To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.

Exclusion Criteria:

  1. Within 72h of any acute myocardial infarction;
  2. Unprotected left main coronary artery disease, triple vessel lesions which need treated all;
  3. Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;
  4. Artery and/or vein bypass graft lesions;
  5. Intracoronary implantation of any branding stents within 1 year;
  6. Severe congestive heart failure (NYHA class III and above), or left ventricular ejection fraction <35% (ultrasound or left ventricular angiography);
  7. Preoperative renal function serum creatinine >2.0mg/DL;
  8. 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;
  9. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
  10. The patient's life expectancy is less than 12 months;
  11. Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
  12. Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
  13. Heart transplantation patients.

Sites / Locations

  • Fu Wai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment group

Arm Description

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

Outcomes

Primary Outcome Measures

In-stent Late Lumen Loss

Secondary Outcome Measures

Participants With Target Lesion Failure
a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Participants With Target Lesion Failure
a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Participants With Target Lesion Failure
a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Participants With Target Lesion Failure
a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Participants With Target Lesion Failure
a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Participants With Target Lesion Failure
a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Major Adverse Cardiac Events
composite endpoint of all cause death, any myocardial infarction and any revascularization
Major Adverse Cardiac Events
composite endpoint of all cause death, any myocardial infarction and any revascularization
Major Adverse Cardiac Events
composite endpoint of all cause death, any myocardial infarction and any revascularization
Major Adverse Cardiac Events
composite endpoint of all cause death, any myocardial infarction and any revascularization
Major Adverse Cardiac Events
composite endpoint of all cause death, any myocardial infarction and any revascularization
Major Adverse Cardiac Events
composite endpoint of all cause death, any myocardial infarction and any revascularization

Full Information

First Posted
February 18, 2016
Last Updated
October 17, 2023
Sponsor
Shanghai MicroPort Medical (Group) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02688842
Brief Title
Evaluation of New Specifications (38mm) of FirehawkTM in the Treatment of Coronary Heart Disease
Acronym
Firehawk_38
Official Title
The Safety and Effectiveness Evaluation of New Specifications (38mm) of FirehawkTM Sirolimus Target-eluting Coronary Stent System in the Treatment of Coronary Heart Disease: a Prospective, Multicenter, Single-group Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai MicroPort Medical (Group) Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
all patients implanted Firehawk stent of new specification (38mm long)
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems
Intervention Type
Device
Intervention Name(s)
Rapamycin target-eluting coronary stent systems (38mm)
Other Intervention Name(s)
Firehawk-38
Primary Outcome Measure Information:
Title
In-stent Late Lumen Loss
Time Frame
9 month after stent implantation
Secondary Outcome Measure Information:
Title
Participants With Target Lesion Failure
Description
a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Time Frame
30 days after stent implantation
Title
Participants With Target Lesion Failure
Description
a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Time Frame
6months after stent implantation
Title
Participants With Target Lesion Failure
Description
a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Time Frame
12 months after stent implantation
Title
Participants With Target Lesion Failure
Description
a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Time Frame
2 years after stent implantation
Title
Participants With Target Lesion Failure
Description
a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Time Frame
3 years after stent implantation
Title
Participants With Target Lesion Failure
Description
a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)
Time Frame
4 years after stent implantation
Title
Major Adverse Cardiac Events
Description
composite endpoint of all cause death, any myocardial infarction and any revascularization
Time Frame
30 days after stent implantation
Title
Major Adverse Cardiac Events
Description
composite endpoint of all cause death, any myocardial infarction and any revascularization
Time Frame
6 months after stent implantation
Title
Major Adverse Cardiac Events
Description
composite endpoint of all cause death, any myocardial infarction and any revascularization
Time Frame
12 months after stent implantation
Title
Major Adverse Cardiac Events
Description
composite endpoint of all cause death, any myocardial infarction and any revascularization
Time Frame
2 years after stent implantation
Title
Major Adverse Cardiac Events
Description
composite endpoint of all cause death, any myocardial infarction and any revascularization
Time Frame
3 years after stent implantation
Title
Major Adverse Cardiac Events
Description
composite endpoint of all cause death, any myocardial infarction and any revascularization
Time Frame
4 years after stent implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 2.75mm 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Runlin Gao, MD
Organizational Affiliation
Fu Wai Hospital & National Center for Cardiovascular Diseases in China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fu Wai Hospital
City
Peking
State/Province
Beijing
ZIP/Postal Code
100037
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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