Comparison One vs Six Months of Dual Antiplatelet Therapy After Implanted Firehawk TM Stent in High Bleeding Risk Patients With Coronary Artery Disease

• Status: Recruiting
• Trial end date: 2023-07-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is to assess the clinical non-inferiority of 1 month (short-term) vs 6 months (long-term) of dual anti-platelet therapy in patients undergoing percutaneous intervention implanted sirolimus -eluting stent with abluminal grooves containing a biodegradable polymer in High Bleeding Risk patients with coronary artery disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
• Treatments: Aspirin; Clopidogrel

Criteria

General Inclusion Criteria:

• Age ≥ 18 years;

• Subjects (or legal guardians) understand the testing requirements and procedures, and provide written informed consent;

• Subjects could undergo percutaneous coronary intervention (PCI);

• Subjects have symptomatic coronary artery disease or have confirmed asymptomatic ischemia;

• Subjects are eligible candidates for coronary artery bypass graft surgery (CABG);

• Left ventricular ejection fraction (LVEF) within 60 days ≥ 30%;

• Subjects were willing to accept the trial plan calls for all subsequent evaluations;

• Subjects can endure 6 months dual anti-platelet therapy, and met one or more criteria as the following:

1.Age ≥ 75years; 2.Subjects with hemoglobin<10g/dL, or subjects received transfusion therapy 4 weeks ago; 3.Subjects with renal insufficiency (eGFR < 60 ml / min); 4. Subjects with HAS-BLED score ≥3.0; 5.Femal patients with acute cononary syndrome; 6.BMI < 18.5 Kg/M2; 7.Subjects with congestive heart failure and with LVEF30%-50%; 8.Subjects had a history of hospitalization due to bleeding; 9.Subjects with thrombocytopenia (platelet < 100,000 / mm3); 10.Subjects had a histroy of intracranial hemorrhage; 11.Subjects had a histroy of intracranial ischemia stroke in 6 months; 12.Subjects plan to receive non-steroidal anti-inflammatory or steroid treatment for more than 30 days after the baseline PCI; 14.Subjects were expected to receive additional treatment after PCI and cannot undergo long-term DAPT therapy; 15.Subjects had a history of stomach ulcers or active ulcers.

Angiographic Inclusion Criteria

• Target lesions must be new and have a visually estimated reference diameter ≥2.25 mm and ≤4.0 mm in autologous coronary artery;

• Target lesions must be moderate-severe calcification;

• No limitations in target lesion length and number, and the number of implanted stents is less than 4;

• ALL target lesion must be able to successfully expand and implant Firehawk™ stent.

Clinical Exclusion Criteria:

• Subjects recently suffer from MI (within 4 week) and ECG changes/clinical symptoms consistent with AMI, or accompanied with increased cardiac biomarkers (CK-MB, CK, TNT or TNI) and at least one of the following :

1. CK-MB> 3ULN, regardless of the value of total CK;

2. If CK-MB or CK was not detected, but cTN> 1ULN, and at least one of the following:

1. Ischemic symptoms and ECG changes of new ischemia;

2. Development of pathologic Q waves in the ECG;

3. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

• Subject had Re-MI before randomized;

• Subject with hemodynamic instability (Killip class IV);

• Subjects were detected ventricular aneurysm greater than 3.0*2.0cm or intraventricular thrombosis by cardiac ultrasonography in 30 days;

• Subjects with Life-threatening arrhythmias;

• Subjects were expected to receive oral anticoagulation therapy after the baseline PCI;

• Subjects cannot endure dual anti-platelet therapy for 1 month;

• Subjects with mechanical complications after myocardial infarction;

• Subjects had an organ transplant or are waiting for an organ transplant;

• Subjects are receiving chemotherapy or will receive a chemotherapy within 30 days after PCI;

• Subjects with abnormal counts of white blood cell (WBC);

• Subjects with verified or suspected acute liver disease, including lab results of acute liver disease;

• Subjects had permanent neurological diseases in the past 6 months;

• Subjects had any PCI (such as balloon angioplasty, stent, cutting balloon) treatment in target vessels within 12 months prior to baseline;

• Non-target vessel had been implanted non-research stent 5 months ago before the baselin PCI.

• Subjects plan to undergo PCI or CABG within 1 year after the baseline PCI;

• Subjects have any coronary endovascular brachytherapy treatment previously;

• Subjects associated with drugs allergy (such as sirolimus, or structure-related compounds fluorinated polymers, thiophenepyridine or aspirin);

• Subjects are suffering from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 12 months;

• Subjects are currently abusing drugs (such as alcohol, cocaine, heroin, etc);

• Subject plan to undergo any operations that may lead to confuse with the programme;

• Subjects were participating in another study of drug or medical device which did not meet its primary endpoint;

• Subjects plan to pregnant within 12 months after baseline;

• Subjects are pregnant or breastfeeding women.

Angiographic Exclusion Criteria (visual estimate):

• Target lesions with the following criteria: left main, saphenous vein grafts or arterial grafts, via saphenous vein grafts or arterial graft, more than 4 stents have been implanted and in-stent sestenosis;

• Subjects with unprotected left main coronary artery disease (diameter stenosis >50%);

• Subjects have a protected left main coronary artery disease (diameter stenosis> 50% and left coronary artery bypass surgery), as well as target lesions located in the LAD and LCX;

• Subjects with other lesions of clinical significance, may be need intervention within 12 months after baseline.