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

AMI Clinical Trial

— CREATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00331578
• Other study ID #: H-06-6
• Status: Completed
• Phase: Phase 4
• First received: May 30, 2006
• Last updated: January 19, 2009
• Start date: June 2006
• Est. completion date: December 2006

Study information

• Verified date: January 2009
• Source: JW Medical Systems Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2077
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AMI

Intervention

Device:
• Excel drug-eluting coronary artery stent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
JW Medical Systems Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE(Major adverse cardiac events)		12 months
Secondary	MACE		30 days and 6 months