Back to resultsExcel Drug-Eluting Stent Pilot Clinical Registry
Primary Purpose
Coronary Stenosis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Excel Drug-eluting stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Stenosis
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.
Sites / Locations
- Shenyang Nothern Hospital
Outcomes
Primary Outcome Measures
12-month MACE
Secondary Outcome Measures
30-day or 6-month MACE
6 to 9-month restenosis rate by SCA follow-up
Full Information
NCT ID
NCT00385905
First Posted
October 10, 2006
Last Updated
October 10, 2006
Sponsor
JW Medical Systems Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00385905
Brief Title
Excel Drug-Eluting Stent Pilot Clinical Registry
Official Title
Excel Drug-Eluting Stent Pilot Clinical Registry
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
JW Medical Systems Ltd
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Excel Drug-eluting stent
Primary Outcome Measure Information:
Title
12-month MACE
Secondary Outcome Measure Information:
Title
30-day or 6-month MACE
Title
6 to 9-month restenosis rate by SCA follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaling Han, Ph.D.
Organizational Affiliation
Shenyang Northern Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shenyang Nothern Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
12. IPD Sharing Statement
Learn more about this trial
Excel Drug-Eluting Stent Pilot Clinical Registry
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