Status:
COMPLETED
Excel Drug-Eluting Stent Pilot Clinical Registry
Lead Sponsor:
JW Medical Systems Ltd
Conditions:
Coronary Stenosis
Eligibility:
All Genders
Phase:
PHASE4
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00385905
Start Date
February 1 2006
End Date
January 1 2007
Last Update
October 11 2006
Active Locations (1)
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1
Shenyang Nothern Hospital
Shenyang, Liaoning, China, 110016