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)

The study aims to further assess the safety, efficacy and the performance of its delivery system of the new generation Sirolimus-eluting stent of JWMS up to five years.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: EXCEL-II biodegradable polymer sirolimus-eluting stent

Detailed Description

1. A prospective, a single set, multicenter clinical trial;
2. The primary in situ in patients with coronary heart disease;
3. 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.)
4. 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: Observational
• Enrollment (Actual): 625

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110015
      • Shenyang Northern Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

the Patients With de Novo Coronary Artery Lesions

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:

1. AMI within 7 days.
2. Left main lesion, transplant vasculopathy and stent restenosis lesion;
3. Severe calcified lesion unable to predilate.
4. The distortion of the stent was hampered by lesions.
5. NYHA≥Ⅲ or LVEF<35%.
6. Prior PCI within 1 year.
7. Pregnancy or lactation, and planning pregnancy or lactation.
8. 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.
9. 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).
10. To aspirin heparin clopidogrel cobalt chromium alloy rapamycin PLA polymer contrast agent of one of allergy.
11. Serious liver and kidney function are not complete subject(ALT and AST were three times greater than the upper limit of normal).
12. Before enrolling to participate in other clinical trials and not reached the primary endpoint.
13. Non-compliant subject and could not finish the trial in accordance with the requirements of the subjects.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EXCEL-II DES; Using EXCEL-II biodegradable polymer sirolimus-eluting stent treating CAD	Device: EXCEL-II biodegradable polymer sirolimus-eluting stent; 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	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	5 Years
TLF, cardiovascular composite endpoints, ARC defined stent thrombosis	30 days, 6 months, and 2-5 years

Collaborators and Investigators

• Sponsor: JW Medical Systems Ltd
• Investigators: Principal Investigator: yaling Han, MD, Shen yang Northern hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2014
• Primary Completion (Actual): July 30, 2017
• Study Completion (Actual): November 7, 2019

Study Registration Dates

• First Submitted: January 2, 2014
• First Submitted That Met QC Criteria: January 2, 2014
• First Posted (Estimate): January 6, 2014

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: PCI; CAD; DES; EXCEL-II; JWMS
• 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