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.
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
625
EXCEL-II biodegradable polymer sirolimus-eluting stent implantation
Shenyang Northern Hospital
Shenyang, Liaoning, China
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
Time frame: 12months
Stent implantation success rate
Time frame: 5 Years
TLF, cardiovascular composite endpoints, ARC defined stent thrombosis
Time frame: 30 days, 6 months, and 2-5 years
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