Excel Drug-Eluting Stent Pilot Clinical Registry

JW Medical Systems Ltd1 site in 1 country100 target enrollmentFebruary 2006

ConditionsCoronary Stenosis

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Coronary Stenosis
Sponsor: JW Medical Systems Ltd
Enrollment: 100
Locations: 1
Primary Endpoint: 12-month MACE
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The Trial aims to evaluate long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.

Detailed Description

30-day, 6-month, and 12-month clinical follow-up and 6 to 9-month IVUS or SCA follow-up to measure long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

January 2007

Last Updated

19 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

JW Medical Systems Ltd

Eligibility Criteria

Inclusion Criteria

•Patients who should fulfill with criteria of implanting Excel stents.
•Each patient enrolled is only allowed to implant Excel stents.
•Each patient are not allowed to be implanted more than 6 Excel stents.Also, 3 over-lapped stents are not allowed to be implanted in the same vessel(3-5mm overlapping needed; length of stents totally are not allowed to be over 80mm; fully post-dilated is essential for overlapping).
•Patients acknowlegement to the trial is essential.

Exclusion Criteria

•AMI withine 1 week.
•Patients who do not suitable to Excel stenting.(For example, non-tolerant to anti-platelet drug or cardiac/non-cardiac surgery undergoing recently.)
•Patients who have multiple branch lesions can not apply single Excel stenting.
•Patients who refuse to sign the Trial Acknowledgement.
•Patients with intra-stent restenosis.