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

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.

Study Overview

• Status: Completed
• Conditions: AMI
• Intervention / Treatment: Device: Excel drug-eluting coronary artery stent

• Study Type: Interventional
• Enrollment (Actual): 2077
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MACE(Major adverse cardiac events)	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
MACE	30 days and 6 months

Collaborators and Investigators

• Sponsor: JW Medical Systems Ltd
• Investigators: Principal Investigator: Yaling Han, Ph.D., Shenyang Northern Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: May 30, 2006
• First Submitted That Met QC Criteria: May 30, 2006
• First Posted (Estimate): May 31, 2006

Study Record Updates

• Last Update Posted (Estimate): January 21, 2009
• Last Update Submitted That Met QC Criteria: January 19, 2009
• Last Verified: January 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: H-06-6