Clinical trial NCT02688829: The First-In-Man Pilot Study of Firehawk
Official title: The Initial Small-Scale Clinical Study of Rapamycin-Eluting Coronary Stent System of Microport (Firehawk)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Sirolimus eluting stents
percutaneous coronary intervention
First in man
Lead sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-02-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 18-75 years of age, males or non-pregnant females;
2. With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction;
3. Total number of target lesion is 1;
4. Target lesion length ≤ 30mm (Visual); target lesion diameter between 2.25mm to 4.0mm;
5. Visual assessment of target lesion diameter stenosis ≥ 70%,TIMI blood flow≥1;
6. Each target lesion may be covered by a single stent;
7. Patients with indications for coronary artery bypass graft surgery;
8. To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.

Exclusion Criteria:

1. Within 1 month of any acute myocardial infarction;
2. 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;
3. Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;
4. In-stent Restenosis lesions;
5. Intracoronary implantation of any branding stents within 1 year;
6. Severe congestive heart failure (NYHA class III and above) ,left ventricular ejection fraction or \<40% (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: Count of Participants With MACE (Major Acute Cardiovascular Events)
timeFrame: 1 month after stent implantation
Secondary outcomes:
measure: In-stent Late Lumen Loss
timeFrame: 4 months after stent implantation
measure: Count of Participants With MACE (Major Acute Cardiovascular Events)
timeFrame: 4 month after stent implantation
measure: Percentage of In-stent Diameter Stenosis
timeFrame: 4 months after stent implantation
measure: In-stent Late Lumen Loss
timeFrame: 13 month after stent implantation
measure: Count of Participants With MACE (Major Acute Cardiovascular Events)
timeFrame: 13 month after stent implantation
measure: Percentage of In-stent Diameter Stenosis
timeFrame: 13 month after stent implantation
Other outcomes:
Locations:
Study officials:
References: