EXCEL-II DES to Treat the Patients With de Novo Coronary Artery Lesions. (CREDIT-III)

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: EXCEL-II biodegradable polymer sirolimus-eluting stent

• Registration Number: NCT02027870
• Lead Sponsor: JW Medical Systems Ltd

Brief Summary

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.

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 Timeline

• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-02
• Study First Posted: 2014-01-06
• Study Start: 2014-01-08
• Primary Completion: 2017-07-30
• Study Completion: 2019-11-07
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 625

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EXCEL-II DES	EXCEL-II biodegradable polymer sirolimus-eluting stent	Using EXCEL-II biodegradable polymer sirolimus-eluting stent treating CAD

Primary Outcome Measures

Name	Time	Method
The Target Lesion Failure(TLF) as the primary endpoint at 12-month	12months	Device-related cardiovascular composite endpoint, including cardiac death, target vessel MI and clinically driven TLR at 12 months post procedure

Secondary Outcome Measures

Name	Time	Method
Stent implantation success rate	5 Years
TLF, cardiovascular composite endpoints, ARC defined stent thrombosis	30 days, 6 months, and 2-5 years

Trial Locations

Locations (1)

Shenyang Northern Hospital; 🇨🇳 Shenyang, Liaoning, China