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CREATE: Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent

Sponsor
JW Medical Systems Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT00331578
Collaborator
(none)
2,077
Enrollment
6
Duration (Months)

Study Details

Study Description

Brief Summary

The trial aims to evaluate 12-month long-term efficiency of Excel stent in the treatment of coronary heart disease and inhibition of restenosis after coronary artery stenting as well as a 12 months' long-term safety after the cessation of clopidogrel as an anti-platelet drugs used for 6 months after the implantation of degradable drug coating stent.

Condition or Disease Intervention/Treatment Phase
  • Device: Excel drug-eluting coronary artery stent
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
2077 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent
Study Start Date :
Jun 1, 2006
Actual Study Completion Date :
Dec 1, 2006

Outcome Measures

Primary Outcome Measures

  1. MACE(Major adverse cardiac events) [12 months]

Secondary Outcome Measures

  1. MACE [30 days and 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Patient who should be full fill the criteria of using Excel stent.

  2. Each included patient should allowed to use Excel stent.

  3. Complete revascularization can be achieved through one invasive operation.

Exclusion Criteria:

  1. Patient do not suitable to use Excel stent, for example, not tolerant to anti-platelet drug or undergo cardiac/non-cardiac surgery recently.

  2. Patient with multiple branch lesions, thus the single Excel stent cannot resolve the condition.

  3. NYH Cardiac functional grading>3 or Echocardiography LVEF<0.3.

  4. Patient with complete revascularization cannot be resolved by one operation.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • JW Medical Systems Ltd

Investigators

  • Principal Investigator: Yaling Han, Ph.D., Shenyang Northern Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00331578
Other Study ID Numbers:
  • H-06-6
First Posted:
May 31, 2006
Last Update Posted:
Jan 21, 2009
Last Verified:
Jan 1, 2009

Study Results

No Results Posted as of Jan 21, 2009