Excel Drug-Eluting Stent Pilot Clinical Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2007-01-31

Brief Summary

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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

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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.

Conditions

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Coronary Stenosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Excel Drug-eluting stent

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Yaling Han, Ph.D.

Role: STUDY_CHAIR

Shenyang Northern Hospital

Locations

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Shenyang Nothern Hospital

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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H-2006-2

Identifier Type: -

Identifier Source: org_study_id