NCT02027870

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 625 (actual)
• Sponsor: JW Medical Systems Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	EXCEL-II biodegradable polymer sirolimus-eluting stent	EXCEL-II biodegradable polymer sirolimus-eluting stent implantation

Timeline

• Start date: 2014-01-08
• Primary completion: 2017-07-30
• Completion: 2019-11-07
• First posted: 2014-01-06
• Last updated: 2023-04-26

Locations

1 site across 1 country: China