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CompletedNCT02688842Firehawk_38Updated Oct 23, 2023Results posted

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

An interventional study of Rapamycin target-eluting coronary stent systems (38mm) in Coronary Heart Disease, sponsored by Shanghai MicroPort Medical (Group) Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by Shanghai MicroPort Medical (Group) Co., Ltd. (part of MicroPort Scientific Corporation) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled May 2014, registered Feb 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Heart Disease

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03

In context

Coronary Disease

2,867 studies on the registry are indexed under Coronary Disease; 309 are open to participants now.

This study's enrollment of 38 is below the median of 124 across 1,601 interventional studies indexed under Coronary Disease.

Browse Coronary Disease studies →

Lead sponsor

Shanghai MicroPort Medical (Group) Co., Ltd. is the lead sponsor of 22 studies on the registry; 3 are open to participants now.

Browse Shanghai MicroPort Medical (Group) Co., Ltd. studies →All MicroPort Scientific Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    treatment group

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

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

Interventions

  • DeviceRapamycin target-eluting coronary stent systems (38mm)

    Also known as: Firehawk-38

06

What researchers measure

Primary outcomes

  1. In-stent Late Lumen Loss

    Time frame: 9 month after stent implantation

Secondary outcomes

  1. 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)

    Time frame: 30 days after stent implantation

  2. 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)

    Time frame: 6months after stent implantation

  3. 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)

    Time frame: 12 months after stent implantation

  4. 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)

    Time frame: 2 years after stent implantation

  5. 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)

    Time frame: 3 years after stent implantation

  6. 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)

    Time frame: 4 years after stent implantation

  7. Major Adverse Cardiac Events

    composite endpoint of all cause death, any myocardial infarction and any revascularization

    Time frame: 30 days after stent implantation

  8. Major Adverse Cardiac Events

    composite endpoint of all cause death, any myocardial infarction and any revascularization

    Time frame: 6 months after stent implantation

  9. Major Adverse Cardiac Events

    composite endpoint of all cause death, any myocardial infarction and any revascularization

    Time frame: 12 months after stent implantation

  10. Major Adverse Cardiac Events

    composite endpoint of all cause death, any myocardial infarction and any revascularization

    Time frame: 2 years after stent implantation

  11. Major Adverse Cardiac Events

    composite endpoint of all cause death, any myocardial infarction and any revascularization

    Time frame: 3 years after stent implantation

  12. Major Adverse Cardiac Events

    composite endpoint of all cause death, any myocardial infarction and any revascularization

    Time frame: 4 years after stent implantation

07

Results

Posted Feb 20, 2020

Participant flow

Participant flow — Overall Study
MilestoneTreatment Group
Started38
Completed38
Not completed0

Outcome measures

PrimaryIn-stent Late Lumen Loss
Time frame:
9 month after stent implantation
Reported as:
Mean · mm
In-stent Late Lumen Loss
mmTreatment Group
In-stent Late Lumen Loss0.19 ± 0.43
SecondaryParticipants 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)

Time frame:
30 days after stent implantation
Reported as:
Count of participants · Participants
Participants With Target Lesion Failure
ParticipantsTreatment Group
Participants With Target Lesion Failure1
SecondaryParticipants 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)

Time frame:
6months after stent implantation
Reported as:
Count of participants · Participants
Participants With Target Lesion Failure
ParticipantsTreatment Group
Participants With Target Lesion Failure1
SecondaryParticipants 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)

Time frame:
12 months after stent implantation
Reported as:
Count of participants · Participants
Participants With Target Lesion Failure
ParticipantsTreatment Group
Participants With Target Lesion Failure2
SecondaryParticipants 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)

Time frame:
2 years after stent implantation
Reported as:
Count of participants · Participants
Participants With Target Lesion Failure
ParticipantsTreatment Group
Participants With Target Lesion Failure2
SecondaryParticipants 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)

Time frame:
3 years after stent implantation
Reported as:
Count of participants · Participants
Participants With Target Lesion Failure
ParticipantsTreatment Group
Participants With Target Lesion Failure2
SecondaryParticipants 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)

Time frame:
4 years after stent implantation
Reported as:
Count of participants · Participants
Participants With Target Lesion Failure
ParticipantsTreatment Group
Participants With Target Lesion Failure2
SecondaryMajor Adverse Cardiac Events

composite endpoint of all cause death, any myocardial infarction and any revascularization

Time frame:
30 days after stent implantation
Reported as:
Count of participants · Participants
Major Adverse Cardiac Events
ParticipantsTreatment Group
Major Adverse Cardiac Events1
SecondaryMajor Adverse Cardiac Events

composite endpoint of all cause death, any myocardial infarction and any revascularization

Time frame:
6 months after stent implantation
Reported as:
Count of participants · Participants
Major Adverse Cardiac Events
ParticipantsTreatment Group
Major Adverse Cardiac Events1
SecondaryMajor Adverse Cardiac Events

composite endpoint of all cause death, any myocardial infarction and any revascularization

Time frame:
12 months after stent implantation
Reported as:
Count of participants · Participants
Major Adverse Cardiac Events
ParticipantsTreatment Group
Major Adverse Cardiac Events4
SecondaryMajor Adverse Cardiac Events

composite endpoint of all cause death, any myocardial infarction and any revascularization

Time frame:
2 years after stent implantation
Reported as:
Count of participants · Participants
Major Adverse Cardiac Events
ParticipantsTreatment Group
Major Adverse Cardiac Events5
SecondaryMajor Adverse Cardiac Events

composite endpoint of all cause death, any myocardial infarction and any revascularization

Time frame:
3 years after stent implantation
Reported as:
Count of participants · Participants
Major Adverse Cardiac Events
ParticipantsTreatment Group
Major Adverse Cardiac Events6
SecondaryMajor Adverse Cardiac Events

composite endpoint of all cause death, any myocardial infarction and any revascularization

Time frame:
4 years after stent implantation
Reported as:
Count of participants · Participants
Major Adverse Cardiac Events
ParticipantsTreatment Group
Major Adverse Cardiac Events7

Adverse events

Collected over 4 year follow up. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment Group0/38 (0%)15/38 (39.5%)25/38 (65.8%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventTreatment Group
RehospitalizationGeneral disorders8/38
AnginaCardiac disorders5/38
non-Target Vessel RevascularizationCardiac disorders4/38
myocardial infarctionCardiac disorders2/38
senile cataractEye disorders2/38
Target Lesion RevascularizationCardiac disorders1/38
lymphomaBlood and lymphatic system disorders1/38
acute cerebral infarctionNervous system disorders1/38
Diastolic dysfunctionCardiac disorders1/38
gastric antrum erosionGastrointestinal disorders1/38
Most frequent other events
Showing 10 of 17
Most frequent other events
EventTreatment Group
myocardial injuryCardiac disorders13/38
InfectionInfections and infestations5/38
elevated myocardial enzymeCardiac disorders2/38
corneal ulcerEye disorders1/38
hypokalemiaGeneral disorders1/38
aneurysmVascular disorders1/38
atrial fibrillationCardiac disorders1/38
heart discomfort after movationCardiac disorders1/38
CoughRespiratory, thoracic and mediastinal disorders1/38
Chronic gastroenteritisGastrointestinal disorders1/38

Baseline characteristics

Age, Continuous
Age, Continuous(years)Treatment Group
Mean61 ± 9.44
Sex: Female, Male
Sex: Female, Male(Participants)Treatment Group
Female8
Male30
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Treatment Group
Region of Enrollment
Region of Enrollment(participants)Treatment Group
China38
Diabetes Mellitus (DM) history
Diabetes Mellitus (DM) history(Participants)Treatment Group
With DM13
Without DM25
Coronary Artery Disease (CAD) history
Coronary Artery Disease (CAD) history(Participants)Treatment Group
With CAD7
Without CAD31
hypertension (HTN) history
hypertension (HTN) history(Participants)Treatment Group
With HTN27
Without HTN11
Cigarette usage
Cigarette usage(Participants)Treatment Group
Never17
Smoker15
Quit smoking1
Relapse5

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Fu Wai Hospital
    Beijing, Beijing Municipality 100037, China
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2014 to primary completion in Jan 2016, 20 months.

Results were first posted in Feb 2020, 4 years 1 month after primary completion.

Of 48 industry-sponsored interventional studies with no phase under Coronary Disease, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 33. This study's 20 months is close to that.

Counting every sponsor, half of 415 studies reached it within 26 months; a quarter within 13 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2016
First posted
Feb 23, 2016
StartActual
May 2014
Primary completionActual
Jan 2016
CompletionActual
Jan 2021
Results first posted
Feb 20, 2020
Last update
Oct 23, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02688842
Lead sponsor
Shanghai MicroPort Medical (Group) Co., Ltd.
Responsible party
Sponsor
First posted
Feb 23, 2016
Start date
May 2014
Primary completion
Jan 2016
Completion
Jan 2021
Results posted
Feb 20, 2020
Last update
Oct 23, 2023

Study contacts

Runlin Gao, MD
principal investigator · Fu Wai Hospital & National Center for Cardiovascular Diseases in China

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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