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Excel Drug-Eluting Stent Pilot Clinical Registry

Sponsor
JW Medical Systems Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT00385905
Collaborator
(none)
100
Enrollment
1
Location
11
Duration (Months)
9.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Excel Drug-eluting stent
 Phase 4

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.

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Excel Drug-Eluting Stent Pilot Clinical Registry
Study Start Date :
Feb 1, 2006
Study Completion Date :
Jan 1, 2007

Outcome Measures

Primary Outcome Measures

  1. 12-month MACE []

Secondary Outcome Measures

  1. 30-day or 6-month MACE []

  2. 6 to 9-month restenosis rate by SCA follow-up []

Eligibility Criteria

Criteria

Ages Eligible for Study:
0 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shenyang Nothern Hospital Shenyang Liaoning China 110016

Sponsors and Collaborators

  • JW Medical Systems Ltd

Investigators

  • Study Chair: Yaling Han, Ph.D., Shenyang Northern Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00385905
Other Study ID Numbers:
  • H-2006-2
First Posted:
Oct 11, 2006
Last Update Posted:
Oct 11, 2006
Last Verified:
Oct 1, 2006
Additional relevant MeSH terms:
Coronary Stenosis

Study Results

No Results Posted as of Oct 11, 2006