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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00331578
Recruitment Status : Completed
First Posted : May 31, 2006
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
JW Medical Systems Ltd

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
AMI Device: Excel drug-eluting coronary artery stent Phase 4

Study Type : Interventional  (Clinical Trial)
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 : June 2006
Study Completion Date : December 2006





Primary Outcome Measures :
  1. MACE(Major adverse cardiac events) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. MACE [ Time Frame: 30 days and 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331578


Sponsors and Collaborators
JW Medical Systems Ltd
Investigators
Principal Investigator: Yaling Han, Ph.D. Shenyang Northern Hospital