Cordimax China Post Market Surveillance

NCT03185221 | Unknown Phase 3 DMC

• 1 other identifier: Branden-456
• Study Type: interventional
• Target: 3,660
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Stenosis

Keywords

Stents Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure(TLF)

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

  at 1st year

Secondary Outcomes (6)

• Thrombotic events incidence

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

• Major adverse cardiovascular events (MACE)

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

• The Success Rate of Stent Placement

  in the operation

• Operation Success Rate

  0 to 24 hours after intervention

• Cost of the hospitalization

  0 to 24hours after discharge

Study Arms (2)

Cordimax

EXPERIMENTAL

Rapamycin Eluting Coronary Stent

Device: Cordimax

XIENCE V

ACTIVE COMPARATOR

Everolimus Eluting Coronary Stent

Device: XIENCE V

Interventions

Cordimax DEVICE

One rapamycin eluting stent for treating the adapted coronary patients

Cordimax

XIENCE V DEVICE

One everolimus eluting stent for treating the adapted coronary patients

XIENCE V

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years old or more
• patients with symptomatic coronary artery disease
• adapt to the DES treatment according to guide
• 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
• patients willing to participate and sign in research

You may not qualify if:

• Women in pregnancy or lactation
• Patients are not adapt to the antiplatelet and/or anticoagulant therapy in the expectation
• Patients were banned to use the antiplatelet and/or anticoagulant therapy
• 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
• Patients who must stop clopidogrel to accept a elective surgery
• 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

Sponsors & Collaborators

• Shandong Branden Med.Device Co.,Ltd: lead
• Fudan University: collaborator

Study Sites (1)

Zhongshan Hospital Fudan University

Beijing, Beijing Municipality, 100032, China

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Junbo Ge

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: June 14, 2017
• Study Start: June 20, 2013
• Primary Completion: June 20, 2019
• Study Completion: June 20, 2020
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)