Cordimax China Post Market Surveillance

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 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

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Stenosis
• Intervention / Treatment: Device: Cordimax; Device: XIENCE V

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) .

• Study Type: Interventional
• Enrollment (Actual): 3660
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Zhongshan Hospital Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cordimax; Rapamycin Eluting Coronary Stent	Device: Cordimax; One rapamycin eluting stent for treating the adapted coronary patients
ACTIVE_COMPARATOR: XIENCE V; Everolimus Eluting Coronary Stent	Device: XIENCE V; One everolimus eluting stent for treating the adapted coronary patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure(TLF)	including Cardiac death, target vessel myocardial infarction, and clinical symptom driven target vessel revascularization	at 1st year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	0 to 24 hours after intervention
Cost of the hospitalization	The total expenses in the process of operation	0 to 24hours after discharge
Length of stay	The total time consumption in the process of operation	0 to 24 hours after discharge

Collaborators and Investigators

• Sponsor: Shandong Branden Med.Device Co.,Ltd
• Collaborators: Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2013
• Primary Completion (ANTICIPATED): June 20, 2019
• Study Completion (ANTICIPATED): June 20, 2020

Study Registration Dates

• First Submitted: May 16, 2017
• First Submitted That Met QC Criteria: June 12, 2017
• First Posted (ACTUAL): June 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 12, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Stents Coronary Artery Disease
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis
• Other Study ID Numbers: Branden-456

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No