Clinical trial NCT02688842: Evaluation of New Specifications (38mm) of FirehawkTM in the Treatment of Coronary Heart Disease
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Lead sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-02-23
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all patients implanted Firehawk stent of new specification (38mm long)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: In-stent Late Lumen Loss
timeFrame: 9 month after stent implantation
Secondary outcomes:
measure: Participants With Target Lesion Failure
timeFrame: 30 days after stent implantation
measure: Participants With Target Lesion Failure
timeFrame: 6months after stent implantation
measure: Participants With Target Lesion Failure
timeFrame: 12 months after stent implantation
measure: Participants With Target Lesion Failure
timeFrame: 2 years after stent implantation
measure: Participants With Target Lesion Failure
timeFrame: 3 years after stent implantation
measure: Participants With Target Lesion Failure
timeFrame: 4 years after stent implantation
measure: Major Adverse Cardiac Events
timeFrame: 30 days after stent implantation
measure: Major Adverse Cardiac Events
timeFrame: 6 months after stent implantation
measure: Major Adverse Cardiac Events
timeFrame: 12 months after stent implantation
measure: Major Adverse Cardiac Events
timeFrame: 2 years after stent implantation
measure: Major Adverse Cardiac Events
timeFrame: 3 years after stent implantation
measure: Major Adverse Cardiac Events
timeFrame: 4 years after stent implantation
Other outcomes:
Locations:
city: Peking
country: China
facility: Fu Wai Hospital
state: Beijing
Study officials:
affiliation: Fu Wai Hospital & National Center for Cardiovascular Diseases in China
name: Runlin Gao, MD
role: PRINCIPAL_INVESTIGATOR
References: