Cordimax China Post Market Surveillance

Launched by SHANDONG BRANDEN MED.DEVICE CO.,LTD · Jun 12, 2017

Keywords

ClinConnect Summary

The purpose of the post market clinical trial is to evaluate the safety and efficacy of the Cordimax Rapamycin Eluting Coronary Stent System (RECS). The Cordimax will be compared to an active control group represented by the FDA approved commercially available Abbott Vascular XIENCE V® EECS Everolimus Eluting Coronary Stent System.

The post market clinical trial consists of a randomized clinical trial (RCT) in China which will enroll approximately 3660 subjects (2:1 randomization Cordimax® RECS : XIENCE V® EECS) with a maximum of two de novo native coronary artery lesion treatment within v...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. age 18 years old or more
• • 2. patients with symptomatic coronary artery disease
• • 3. adapt to the DES treatment according to guide
• • 4. with one or more in diameter of the stenosis of 50% or more coronary artery lesions (refer to 2.5\~4.0 mm) in diameter ;has the objective basis of myocardial ischemia
• • 5. patients willing to participate and sign in research
• Exclusion Criteria:
• • 1. Women in pregnancy or lactation
• • 2. Patients are not adapt to the antiplatelet and/or anticoagulant therapy in the expectation
• • 3. Patients were banned to use the antiplatelet and/or anticoagulant therapy
• • 4. Patients have participated in other devices or drugs or other research at the same time, and have not yet reached the end of the research project
• • 5. Patients who must stop clopidogrel to accept a elective surgery
• • 6. patients that the researchers think who are not suitable for stent placement and unable to complete the follow-up, such as the late malignant tumor patients, patients with severe liver and kidney disease, cerebral apoplexy patients, severe infection and severe patients with diseases of the blood system