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

This study has been completed.
Sponsor:
Information provided by:
JW Medical Systems Ltd
ClinicalTrials.gov Identifier:
NCT00331578
First received: May 30, 2006
Last updated: January 19, 2009
Last verified: January 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent

Resource links provided by NLM:


Further study details as provided by JW Medical Systems Ltd:

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

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

Enrollment: 2077
Study Start Date: June 2006
Study Completion Date: December 2006
  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331578

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