Cordimax China Post Market Surveillance

NCT ID: NCT03185221

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 3660 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-20
• Study Completion Date: 2020-06-20

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) .

Conditions

Coronary Artery Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cordimax

Rapamycin Eluting Coronary Stent

Group Type: EXPERIMENTAL

Cordimax

Intervention Type: DEVICE

One rapamycin eluting stent for treating the adapted coronary patients

XIENCE V

Everolimus Eluting Coronary Stent

Group Type: ACTIVE_COMPARATOR

XIENCE V

Intervention Type: DEVICE

One everolimus eluting stent for treating the adapted coronary patients

Interventions

Cordimax

One rapamycin eluting stent for treating the adapted coronary patients

Intervention Type: DEVICE

XIENCE V

One everolimus eluting stent for treating the adapted coronary patients

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: collaborator

Shandong Branden Med.Device Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junbo Ge

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Zhongshan Hospital Fudan University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

Branden-456

Identifier Type: -

Identifier Source: org_study_id