Clinical trial NCT03185221: Cordimax China Post Market Surveillance
Official title: Comparing the Safety and Efficacy of Cordimax and Xience V Drug-eluting Stents, for the Treatment of Coronary Heart Disease (CHD) in the Clinical Research of Real World
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Stenosis
Keywords: Stents Coronary Artery Disease
Lead sponsor: Shandong Branden Med.Device Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Fudan University
First posted: 2017-06-14
Enrollment: 3660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study purpose: This study is a prospective, randomized, controlled multicenter clinical research, which is to assess the effect of Cordimax and Xience V drug-eluting stents as they dealing with all kinds of complex lesions in the real world.

Study group Experimental group: Cordimax® Rapamycin Eluting Coronary Stent System Control group: XIENCE V® Everolimus Eluting Coronary Stent System

Detailed description: 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 vessel sizes \>= 2.5 mm and \<= 4 mm.

All subjects in the RCT will be screened per the protocol required inclusion/exclusion criteria. The data collected will be compared to data from the subjects enrolled into the XIENCE V® arm of US RCT.

All subjects will have clinical follow-up at 30, 60, 90days, and 1, 2, 3, 4, and 5 years so as to collect the needed data for the subsequent analysis.(Data collecting at 1st year will be conducted in the clinic in order to get the 12 lead ecg result once after out of the hospital) .

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

Primary outcomes:
measure: Target Lesion Failure(TLF)
timeFrame: at 1st year
Secondary outcomes:
measure: Thrombotic events incidence
timeFrame: at30 60 90 days and 1st 2st 3st 4st 5st year
measure: Major adverse cardiovascular events (MACE)
timeFrame: at30 60 90 days and 1st 2st 3st 4st 5st year
measure: The Success Rate of Stent Placement
timeFrame: in the operation
measure: Operation Success Rate
timeFrame: 0 to 24 hours after intervention
measure: Cost of the hospitalization
timeFrame: 0 to 24hours after discharge
measure: Length of stay
timeFrame: 0 to 24 hours after discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhongshan Hospital Fudan University
state: Beijing
Study officials:
affiliation: Fudan University
name: Junbo Ge
role: PRINCIPAL_INVESTIGATOR
References: