Excel Drug-Eluting Stent Pilot Clinical Registry

JW Medical Systems

Status and phase

Completed

Phase 4

Conditions

Coronary Stenosis

Treatments

Device: Excel Drug-eluting stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00385905

H-2006-2

Details and patient eligibility

About

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.

Full 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.

Sex

All

Volunteers

No Healthy Volunteers

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.