Multi-Center Registry Trial of EXCEL Biodegradable Polymer Drug-Eluting Stent (CREATE)
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ClinicalTrials.gov Identifier: NCT00331578 |
Recruitment Status :
Completed
First Posted : May 31, 2006
Last Update Posted : January 21, 2009
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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 |
Actual Study Completion Date : | December 2006 |

- MACE(Major adverse cardiac events) [ Time Frame: 12 months ]
- MACE [ Time Frame: 30 days and 6 months ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient who should be full fill the criteria of using Excel stent.
- Each included patient should allowed to use Excel stent.
- Complete revascularization can be achieved through one invasive operation.
Exclusion Criteria:
- Patient do not suitable to use Excel stent, for example, not tolerant to anti-platelet drug or undergo cardiac/non-cardiac surgery recently.
- Patient with multiple branch lesions, thus the single Excel stent cannot resolve the condition.
- NYH Cardiac functional grading>3 or Echocardiography LVEF<0.3.
- Patient with complete revascularization cannot be resolved by one operation.

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
Principal Investigator: | Yaling Han, Ph.D. | Shenyang Northern Hospital |
ClinicalTrials.gov Identifier: | NCT00331578 |
Other Study ID Numbers: |
H-06-6 |
First Posted: | May 31, 2006 Key Record Dates |
Last Update Posted: | January 21, 2009 |
Last Verified: | January 2009 |