Coronary Heart DiseaseNCT02688829

The First-In-Man Pilot Study of Firehawk

A study testing Rapamycin target-eluting Coronary Stent System in people with Coronary Heart Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd..

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Coronary Heart Disease
What is being tested?: Rapamycin target-eluting Coronary Stent System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: No sites listed yet
Study dates: Dec 2009to Jan 2015
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18-75 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.

Who cannot join

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);

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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.

About this study

Official title: The Initial Small-Scale Clinical Study of Rapamycin-Eluting Coronary Stent System of Microport (Firehawk)

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
Being tested: Rapamycin target-eluting Coronary Stent System
Keywords: Sirolimus eluting stents, percutaneous coronary intervention, First in man
Medical subject headings: Coronary Disease

What participants receive

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

Rapamycin target-eluting Coronary Stent SystemDevice
Also called Firehawk
Implantation of the rapamycin-eluting coronary stent system

Study groups in NCT02688829
Study group	Role	What they receive
treatment group	Experimental	Implantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease. Receives: Device: Rapamycin target-eluting Coronary Stent System

What is being measured

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

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.
Measured: 1 month after stent implantation

Secondary outcomes (6)

In-stent Late Lumen Loss
In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 4 months follow-up in-stent minimal lumen diameter.
Measured: 4 months after stent implantation
Count of Participants With MACE (Major Acute Cardiovascular Events)
Count of Participants who have major acute cardiovascular events (MACE) in 4 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.
Measured: 4 month after stent implantation
Percentage of In-stent Diameter Stenosis
Percentage of in-stent diameter stenosis is calculated by the following fomula: (RVD-MLD)/RVD * 100%.
RVD: Reference vessel diameter, represents the averaged diameter of the coronary assumed without atherosclerotic disease.
MLD: Minimal luminal diameter, represents the smallest lumen diameter in the segment of interest.
Measured: 4 months after stent implantation
In-stent Late Lumen Loss
In-stent late lumen loss (In-stent LLL) is defined as the difference between the post-procedure and 13 months follow-up in-stent minimal lumen diameter.
Measured: 13 month after stent implantation
Count of Participants With MACE (Major Acute Cardiovascular Events)
Count of Participants who have major acute cardiovascular events (MACE) in 13 months follow-up, MACE defined as the composite of cardiac death, myocardial infarction(Q and non-Q) and ischemia driven target lesion revascularization.
Measured: 13 month after stent implantation
Percentage of In-stent Diameter Stenosis
Percentage of in-stent diameter stenosis is calculated by the following fomula: (RVD-MLD)/RVD * 100%.
RVD: Reference vessel diameter, represents the averaged diameter of the coronary assumed without atherosclerotic disease.
MLD: Minimal luminal diameter, represents the smallest lumen diameter in the segment of interest.
Measured: 13 month after stent implantation

Timeline

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

Dec 2009Jan 2015

First posted23 Feb 2016 (estimated)
Study startDec 2009
Primary completionJan 2010
Study completionJan 2015

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: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02688829
Sponsor's protocol ID: Firehawk_FIM
Status last verified: Sep 2019
First submitted: 18 Feb 2016
Last updated: 17 Oct 2019
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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Initial Small-Scale Clinical Study of Rapamycin-Eluting Coronary Stent System of Microport (Firehawk)
ClinicalTrials.gov ID: NCT02688829
Acronym / sponsor ID: Firehawk_FIM
Conditions: Coronary Heart Disease
Keywords: Sirolimus eluting stents, percutaneous coronary intervention, First in man
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.Industry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2015 (actual)
First posted: 23 Feb 2016 (estimated)
Results: Posted 17 Oct 2019

Clinical summary

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

Study design

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

Arm	Type	Receives
treatment group	Experimental	Device: Rapamycin target-eluting Coronary Stent SystemImplantation of the rapamycin target-eluting coronary stent system (Firehawk)in patients with coronary heart disease.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

18-75 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;

Key exclusion criteria (13 listed)

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;

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
Rapamycin target-eluting Coronary Stent SystemAlso: FirehawkImplantation of the rapamycin-eluting coronary stent system	Device	treatment group

Primary outcome

Count of Participants With MACE (Major Acute Cardiovascular Events)
Time frame: 1 month after stent implantation
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.

6 secondary outcomes

In-stent Late Lumen Loss
Time frame: 4 months after stent implantation
Count of Participants With MACE (Major Acute Cardiovascular Events)
Time frame: 4 month after stent implantation
Percentage of In-stent Diameter Stenosis
Time frame: 4 months after stent implantation
In-stent Late Lumen Loss
Time frame: 13 month after stent implantation
Count of Participants With MACE (Major Acute Cardiovascular Events)
Time frame: 13 month after stent implantation
Percentage of In-stent Diameter Stenosis
Time frame: 13 month after stent implantation

Results and safety

Results posted to the registry on 17 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Group	21	19

Primary outcome: Count of Participants With MACE (Major Acute Cardiovascular Events)

Time frame: 1 month after stent implantation. Count of participants. Unit: Participants

Measure	Treatment Group n = 21
Value	0

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group	2 of 21 (9.5%)	0 of 21 (0%)	1 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Rapamycin target-eluting Coronary Stent System in people with Coronary Heart Disease, run by Shanghai MicroPort Medical (Group) Co., Ltd..

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 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

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 17 Oct 2019). 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?

Count of Participants With MACE (Major Acute Cardiovascular Events) (time frame: 1 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 NCT02688829.

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 17 Oct 2019.