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

• ClinicalTrials.gov Identifier: NCT00331578
• Recruitment Status: Completed
• First Posted: May 31, 2006
• Last Update Posted: January 21, 2009
• Sponsor: JW Medical Systems Ltd
• Information provided by: JW Medical Systems Ltd

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

Study Design

• 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

Arms and Interventions

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• 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.

Contacts and Locations

Sponsors and Collaborators

JW Medical Systems Ltd

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Li Y, Han Y, Zhang L, Jing Q, Wang X, Yan G, Ma Y, Wang G, Wang S, Chen X, Yang L, Zhu G, Liu H, Jiang T. Clinical efficacy and safety of biodegradable polymer-based sirolimus-eluting stents in patients with diabetes mellitus insight from the 4-year results of the create study. Catheter Cardiovasc Interv. 2013 Jun 1;81(7):1127-33. doi: 10.1002/ccd.24649. Epub 2013 Feb 26.

Han Y, Jing Q, Xu B, Yang L, Liu H, Shang X, Jiang T, Li Z, Zhang H, Li H, Qiu J, Liu Y, Li Y, Chen X, Gao R; CREATE (Multi-Center Registry of Excel Biodegradable Polymer Drug-Eluting Stents) Investigators. Safety and efficacy of biodegradable polymer-coated sirolimus-eluting stents in "real-world" practice: 18-month clinical and 9-month angiographic outcomes. JACC Cardiovasc Interv. 2009 Apr;2(4):303-9. doi: 10.1016/j.jcin.2008.12.013.

• ClinicalTrials.gov Identifier: NCT00331578
• Other Study ID Numbers: H-06-6
• First Posted: May 31, 2006
• Last Update Posted: January 21, 2009
• Last Verified: January 2009