Coronary Heart DiseaseNCT02688868

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

A study testing FirehawkTM 2.25mm in people with Coronary Heart Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Coronary Heart Disease
What is being tested?: FirehawkTM 2.25mm
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteChina
Study dates: May 2014to Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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);

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Fu Wai Hospital
Beijing, Beijing Municipality, 100037

Other trials in China

About this study

Official title: 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.

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
Being tested: FirehawkTM 2.25mm
Medical subject headings: Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02688868
Study group	Role	What they receive
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 Receives: Device: FirehawkTM 2.25mm

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 9 month after stent implantation

Secondary outcomes (8)

Number of Participants With Target Lesion Failure
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Measured: 12 months
Number of Participants With Target Lesion Failure
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Measured: 2 years
Number of Participants With Target Lesion Failure
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Measured: 3 years
Number of Participants With Target Lesion Failure
including cardiac death, target vessel myocardial infarction and clinical symptom-driven target lesion revascularization
Measured: 4 years
Number of Participants With MACE
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Measured: 12 months
Number of Participants With MACE
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Measured: 2 years
Number of Participants With MACE
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Measured: 3 years
Number of Participants With MACE
a composite endpoint of all cause death, any myocardial infarction and any revascularization
Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Dec 2020

First posted23 Feb 2016 (estimated)
Study startMay 2014
Primary completionDec 2015
Study completionDec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02688868
Sponsor's protocol ID: Firehawk_SS
Status last verified: May 2020
First submitted: 18 Feb 2016
Last updated: 23 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT02688868
Acronym / sponsor ID: Firehawk_SS
Conditions: Coronary Heart Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.Industry (pharma, biotech, devices)
Study start: May 2014 (actual)
Primary completion: Dec 2015 (actual)
Study completion: Dec 2020 (actual)
First posted: 23 Feb 2016 (estimated)
Results: Posted 20 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
new specifications (Diameter 2.25mm)of Firehawk stent	Experimental	Device: FirehawkTM 2.25mmEvaluation of new specifications (Diameter 2.25mm) of FirehawkTM in the treatment of coronary heart disease

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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);

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FirehawkTM 2.25mmImplantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems	Device	new specifications (Diameter 2.25mm)of Firehawk stent

Primary outcome

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.

8 secondary outcomes

Number of Participants With Target Lesion Failure
Time frame: 12 months
Number of Participants With Target Lesion Failure
Time frame: 2 years
Number of Participants With Target Lesion Failure
Time frame: 3 years
Number of Participants With Target Lesion Failure
Time frame: 4 years
Number of Participants With MACE
Time frame: 12 months
Number of Participants With MACE
Time frame: 2 years
Number of Participants With MACE
Time frame: 3 years
Number of Participants With MACE
Time frame: 4 years

Results and safety

Results posted to the registry on 20 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
New Specifications (Diameter 2.25mm)of Firehawk Stent	38	34

Primary outcome: In-stent Late Loss

Time frame: 9 month after stent implantation. Mean (Standard Deviation). Unit: mm

Measure	New Specifications (Diameter 2.25mm)of Firehawk Stent n = 34
Value	0.29 (0.57)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
New Specifications (Diameter 2.25mm)of Firehawk Stent	28 of 38 (73.7%)	32 of 38 (84.2%)	1 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Runlin Gao, MD principal investigator

Fu Wai Hospital & National Center for Cardiovascular Diseases in China

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FirehawkTM 2.25mm in people with Coronary Heart Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent Late Loss (time frame: 9 month after stent implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02688868.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.