Cordimax China Post Market Surveillance

Shandong Branden Med.Device

Status and phase: Unknown; Phase 3

Conditions: Coronary Artery Stenosis

Treatments: Device: Cordimax; Device: XIENCE V

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03185221

Branden-456

Details and patient eligibility

About

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

Full 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) .

Enrollment: 3,660 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,660 participants in 2 patient groups

Cordimax

Experimental group

Description:

Rapamycin Eluting Coronary Stent

Treatment:

Device: Cordimax

XIENCE V

Active Comparator group

Description:

Everolimus Eluting Coronary Stent

Treatment:

Device: XIENCE V