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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02688842

Acronym

Firehawk_38

Enrollment

Registered

2016-02-23

Start date

2014-05-31

Completion date

2021-01-31

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

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.

Interventions

DEVICERapamycin target-eluting coronary stent systems (38mm)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

all patients implanted Firehawk stent of new specification (38mm long)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
In-stent Late Lumen Loss	9 month after stent implantation

Secondary

Measure	Time frame	Description
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)
Major Adverse Cardiac Events	30 days after stent implantation	composite endpoint of all cause death, any myocardial infarction and any revascularization

Countries

China

Participant flow

Participants by arm

Arm	Count
Treatment Group Implantation of the released specification (38mm) of FirehawkTM rapamycin target-eluting coronary stent systems Rapamycin target-eluting coronary stent systems (38mm)	38
Total	38

Baseline characteristics

Characteristic	Treatment Group	—
Age, Continuous	61 years STANDARD_DEVIATION 9.44	—
Cigarette usage Never	17 Participants	—
Cigarette usage Quit smoking	1 Participants	—
Cigarette usage Relapse	5 Participants	—
Cigarette usage Smoker	15 Participants	—
Coronary Artery Disease (CAD) history With CAD	7 Participants	—
Coronary Artery Disease (CAD) history Without CAD	31 Participants	—
Diabetes Mellitus (DM) history With DM	13 Participants	—
Diabetes Mellitus (DM) history Without DM	25 Participants	—
hypertension (HTN) history With HTN	27 Participants	—
hypertension (HTN) history Without HTN	11 Participants	—
Myocardial Infarction (MI) history With MI	13 Participants	—
Myocardial Infarction (MI) history Without MI	25 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment China	38 participants	—
Sex: Female, Male Female	8 Participants	—
Sex: Female, Male Male	30 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 38
other Total, other adverse events	25 / 38
serious Total, serious adverse events	15 / 38

Outcome results

Primary

In-stent Late Lumen Loss

Time frame: 9 month after stent implantation

Population: 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	Measure	Value (MEAN)	Dispersion
Treatment Group	In-stent Late Lumen Loss	0.19 mm	Standard Deviation 0.43

Secondary