Excel Drug-Eluting Stent Pilot Clinical Registry

JW Medical Systems Ltd100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Coronary Stenosis

Interventions

Excel Drug-eluting stentDEVICE

Eligibility

Sex: ALLMin age: 0 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shenyang Nothern Hospital

Shenyang, Liaoning, China

Outcomes

Primary Outcomes

12-month MACE

Secondary Outcomes

30-day or 6-month MACE

6 to 9-month restenosis rate by SCA follow-up

Data from ClinicalTrials.gov

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