Cordimax China Post Market Surveillance

Shandong Branden Med.Device Co.,Ltd3,660 enrolled

Overview

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

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) .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

3,660

Conditions

Coronary Artery Stenosis

Interventions

CordimaxDEVICE

One rapamycin eluting stent for treating the adapted coronary patients

XIENCE VDEVICE

One everolimus eluting stent for treating the adapted coronary patients

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhongshan Hospital Fudan University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Target Lesion Failure(TLF)

including Cardiac death, target vessel myocardial infarction, and clinical symptom driven target vessel revascularization

Time frame: at 1st year

Secondary Outcomes

Thrombotic events incidence

According to ARC definition it includes deterministic thrombosis, possible thrombosis and not eliminating thrombosis; point-in-time include acute within 24h, subacute between 2 and 30 d and later period over 30 d

Time frame: at30 60 90 days and 1st 2st 3st 4st 5st year

Major adverse cardiovascular events (MACE)

Events include cardiac death, myocardial infarction of target vessel and target lesion revascularization (TLR) by clinical-driven

Time frame: at30 60 90 days and 1st 2st 3st 4st 5st year

The Success Rate of Stent Placement

The stent can arrive and through the target lesion area, and can be expanded finally.

Time frame: in the operation

Operation Success Rate

After stent implantation, stent diameter stenosis \< 30% (visual), TIMI flow class 3, and hospitalization MACE events did not happen.

Time frame: 0 to 24 hours after intervention

Cost of the hospitalization

The total expenses in the process of operation

Time frame: 0 to 24hours after discharge

Length of stay

The total time consumption in the process of operation

Time frame: 0 to 24 hours after discharge

Data from ClinicalTrials.gov

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