- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02027870
EXCEL-II DES to Treat the Patients With de Novo Coronary Artery Lesions. (CREDIT-III) (CREDIT-III)
A Prospective Multicenter Single-Arm Observational Registry Study to Assess the Safety and Efficacy of EXCEL-II With Sirolimus Eluting Stent for the Treatment of Patients With de Novo Coronary Artery . (CREDIT-III Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
- A prospective, a single set, multicenter clinical trial;
- The primary in situ in patients with coronary heart disease;
- The center of: 28 (the actual number of center shall prevail);The plan selected 621 patients;(where the total number of cases in 2.25 mm specification not less than 30 cases, 5 cases each specification of not less than 2.25 mm.)
- Clinical follow-up time points: 1 months, 6 months, 12 months and 18 months of a year and 2 years to 5 years follow-up; This test by an independent coronary angiography core laboratories, data management and statistical center, clinical end points to judge committee and clinical monitoring of all relevant clinical and imaging data collecting, sorting, statistical analysis and judgement.All the selected patients within five years continuous follow-up tracking (phone or outpatient follow-up), to observe the happening of adverse events to the forward of the second generation of EXCEL drug-eluting stents (des) system security to make more accurate and credible evaluation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: gangtao wang
- Phone Number: +86 010 68068918
- Email: gangtao.wang@jwmsgrp.com
Study Contact Backup
- Name: yan lin
- Phone Number: +86 010 68068918
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 110015
- Shenyang Northern Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
1.18yrs≤Age≤75yrs . 2..stability and unstable angina pectoris (AP), chronic myocardial infarction (OMI) or confirmed (myocardial ischemia; 3.De novo lesion at native coronary artery(Up to four target lesions). 4.Lesion length ≤60mm. 5.RVD 2.25mm~4.0mm. 6.DS%≥70% by visual estimation. 7.Coronary artery bypass surgery (coronary artery bypass grafting) patients. 8.Subjects are willing to follow the specified requirements follow-up.
9.To understand the purpose of testing, voluntary and signed informed consent, willing to accept the imaging and clinical follow-up of subjects.
Exclusion Criteria:
- AMI within 7 days.
- Left main lesion, transplant vasculopathy and stent restenosis lesion;
- Severe calcified lesion unable to predilate.
- The distortion of the stent was hampered by lesions.
- NYHA≥Ⅲ or LVEF<35%.
- Prior PCI within 1 year.
- Pregnancy or lactation, and planning pregnancy or lactation.
- Subjects have bleeding tendency or blood coagulation dysfunction or PCI contraindications, or anticoagulant therapy taboo or can't continue to take DAPT at least 1 year.
- There are other diseases (such as cancer,malignant tumor ,congestive heart failure,organ transplantation or candidate) or abuse history (alcohol cocaine heroin, etc.), scheme compliance is poor, interference related data explanation or the limited life (< 1 year).
- To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy.
- Serious liver and kidney function are not complete subject(ALT and AST were three times greater than the upper limit of normal).
- Before enrolling to participate in other clinical trials and not reached the primary endpoint.
- Non-compliant subject and could not finish the trial in accordance with the requirements of the subjects.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
EXCEL-II DES
Using EXCEL-II biodegradable polymer sirolimus-eluting stent treating CAD
|
EXCEL-II biodegradable polymer sirolimus-eluting stent implantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Target Lesion Failure(TLF) as the primary endpoint at 12-month
Time Frame: 12months
|
Device-related cardiovascular composite endpoint, including cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure
|
12months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Stent implantation success rate
Time Frame: 5 Years
|
5 Years
|
TLF, cardiovascular composite endpoints, ARC defined stent thrombosis
Time Frame: 30 days, 6 months, and 2-5 years
|
30 days, 6 months, and 2-5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: yaling Han, MD, Shen yang Northern hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- CREDIT-III-131113
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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