Excel Drug-Eluting Stent Pilot Clinical Registry | NCT00385905

Studies
Excel Drug-Eluting Stent Pilot Clinical Registry

NCT00385905

Sponsor

JW Medical Systems Ltd

Status

Completed

Last Update Posted

Oct 11, 2006Estimated

Enrollment

100

Phase

Phase 4

Conditions

Coronary Stenosis

Interventions

Excel Drug-eluting stent

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Not provided

Completion Date

Jan 2007

First Submitted Date

Oct 10, 2006

First Submission Date that Met QC Criteria

Oct 10, 2006

First Posted Date

Oct 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2006

Last Update Posted Date

Oct 11, 2006Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
Excel Drug-eluting stent	Device

Measure	Description	Time Frame
12-month MACE

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yaling Han, Ph.D.	Shenyang Northern Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shenyang Nothern Hospital		Shenyang	Liaoning	110016	China

Condition Browse Module

MeSH Terms

ID	Term
D023921	Coronary Stenosis

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
30-day or 6-month MACE
6 to 9-month restenosis rate by SCA follow-up