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

Phase 4

Completed

• Conditions: AMI

• Registration Number: NCT00331578
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-30
• Study First Posted: 2006-05-31
• Study Start: 2006-06
• Study Completion: 2006-12
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-19
• Last Update Posted: 2009-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2077

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
MACE(Major adverse cardiac events)	12 months

Secondary Outcome Measures

Name	Time	Method
MACE	30 days and 6 months