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

• Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02688842
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 80.1
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease	Device: Rapamycin target-eluting coronary stent systems (38mm)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: all patients implanted Firehawk stent of new specification (38mm long)all patients implanted Firehawk stent of new specification (38mm long)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: May 1, 2014
• Actual Primary Completion Date: Jan 1, 2016
• Anticipated Study Completion Date: Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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); Other Names: Firehawk-38

Outcome Measures

Primary Outcome Measures

1. In-stent Late Lumen Loss [9 month after stent implantation]

Secondary Outcome Measures

1. Participants With Target Lesion Failure [30 days after stent implantation]

   a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)

2. Participants With Target Lesion Failure [6months after stent implantation]

   a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)

3. Participants With Target Lesion Failure [12 months after stent implantation]

   a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)

4. Participants With Target Lesion Failure [2 years after stent implantation]

   a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)

5. Participants With Target Lesion Failure [3 years after stent implantation]

   a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)

6. Participants With Target Lesion Failure [4 years after stent implantation]

   a composite endpoint of cardiac death, myocardial infarction related to target vessel (TVMI) and clinically-indicated revascularization related to target lesion (CI-TLR)

7. Major Adverse Cardiac Events [30 days after stent implantation]

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

8. Major Adverse Cardiac Events [6 months after stent implantation]

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

9. Major Adverse Cardiac Events [12 months after stent implantation]

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

10. Major Adverse Cardiac Events [2 years after stent implantation]

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

11. Major Adverse Cardiac Events [3 years after stent implantation]

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

12. Major Adverse Cardiac Events [4 years after stent implantation]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fu Wai Hospital	Peking	Beijing	China	100037

Sponsors and Collaborators

• Shanghai MicroPort Medical (Group) Co., Ltd.

Investigators

• Principal Investigator: Runlin Gao, MD, Fu Wai Hospital & National Center for Cardiovascular Diseases in China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai MicroPort Medical (Group) Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02688842
• Other Study ID Numbers: Firehawk_LS
• First Posted: Feb 23, 2016
• Last Update Posted: May 27, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Sirolimus

Study Results

Participant Flow

Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
Period Title: Overall Study
STARTED	38
COMPLETED	38
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
Overall Participants	38
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61 (9.44)
Sex: Female, Male (Count of Participants)
Female	8 21.1%
Male	30 78.9%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
China	38 100%
Diabetes Mellitus (DM) history (Count of Participants)
With DM	13 34.2%
Without DM	25 65.8%
Coronary Artery Disease (CAD) history (Count of Participants)
With CAD	7 18.4%
Without CAD	31 81.6%
hypertension (HTN) history (Count of Participants)
With HTN	27 71.1%
Without HTN	11 28.9%
Cigarette usage (Count of Participants)
Never	17 44.7%
Smoker	15 39.5%
Quit smoking	1 2.6%
Relapse	5 13.2%
Myocardial Infarction (MI) history (Count of Participants)
With MI	13 34.2%
Without MI	25 65.8%

Outcome Measures

1. Primary Outcome

Title	In-stent Late Lumen Loss
Time Frame	9 month after stent implantation

Outcome Measure Data

Analysis Population Description

A sum of 31 patients with 33 target lesions were analyzed by Quantitative Coronary Angiography (QCA). 7 participants did not participate in 9 month angiographic follow up.

Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
Measure Participants	31
Measure target stent	33
Mean (Standard Deviation) [mm]	0.19 (0.43)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
Measure Participants	38
Count of Participants [Participants]	1 2.6%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
Measure Participants	38
Count of Participants [Participants]	1 2.6%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
Measure Participants	38
Count of Participants [Participants]	2 5.3%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
Measure Participants	38
Count of Participants [Participants]	2 5.3%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

One participant was lost during 3 years follow up.

Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
Measure Participants	37
Count of Participants [Participants]	2 5.3%

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

One participant was lost during 4 years follow up.

Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
Measure Participants	37
Count of Participants [Participants]	2 5.3%

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
Measure Participants	38
Count of Participants [Participants]	1 2.6%

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
Measure Participants	38
Count of Participants [Participants]	1 2.6%

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
Measure Participants	38
Count of Participants [Participants]	4 10.5%

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
Measure Participants	38
Count of Participants [Participants]	5 13.2%

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

One participant was lost during 3 years follow up.

Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
Measure Participants	37
Count of Participants [Participants]	6 15.8%

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

One participant was lost during 4 years follow up.

Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
Measure Participants	37
Count of Participants [Participants]	7 18.4%

Adverse Events

Time Frame	4 year follow up
Arm/Group Title	Treatment Group
Arm/Group Description	Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)
All Cause Mortality
	Treatment Group
	Affected / at Risk (%)	# Events
Total	0/38 (0%)
Serious Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	15/38 (39.5%)
Blood and lymphatic system disorders
lymphoma	1/38 (2.6%)	1
Cardiac disorders
Target Lesion Revascularization	1/38 (2.6%)	1
Angina	5/38 (13.2%)	5
myocardial infarction	2/38 (5.3%)	2
non-Target Vessel Revascularization	4/38 (10.5%)	4
Diastolic dysfunction	1/38 (2.6%)	1
coronary artery disease	1/38 (2.6%)	1
Eye disorders
senile cataract	2/38 (5.3%)	2
Gastrointestinal disorders
gastric antrum erosion	1/38 (2.6%)	1
General disorders
Rehospitalization	8/38 (21.1%)	8
Metabolism and nutrition disorders
Diabetes Mellitus	1/38 (2.6%)	1
Nervous system disorders
acute cerebral infarction	1/38 (2.6%)	1
Other (Not Including Serious) Adverse Events
	Treatment Group
	Affected / at Risk (%)	# Events
Total	25/38 (65.8%)
Cardiac disorders
elevated myocardial enzyme	2/38 (5.3%)	2
atrial fibrillation	1/38 (2.6%)	1
heart discomfort after movation	1/38 (2.6%)	1
premature ventricular contraction	1/38 (2.6%)	1
myocardial injury	13/38 (34.2%)	13
palpitation	1/38 (2.6%)	1
angina	1/38 (2.6%)	1
Eye disorders
corneal ulcer	1/38 (2.6%)	1
Gastrointestinal disorders
Chronic gastroenteritis	1/38 (2.6%)	1
General disorders
hypokalemia	1/38 (2.6%)	1
Pain	1/38 (2.6%)	1
Infections and infestations
Infection	5/38 (13.2%)	5
Nervous system disorders
vertigo	1/38 (2.6%)	1
Renal and urinary disorders
renal cyst	1/38 (2.6%)	1
Respiratory, thoracic and mediastinal disorders
Cough	1/38 (2.6%)	1
Short breath	1/38 (2.6%)	1
Vascular disorders
aneurysm	1/38 (2.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.