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

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.

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Key information

Conditions

AMI

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Excel drug-eluting coronary artery stent

Device

Primary outcomes

MACE(Major adverse cardiac events)

Time frame: 12 months

Secondary outcomes

MACE

Time frame: 30 days and 6 months

Sponsors and collaborators

Lead sponsor

JW Medical Systems Ltd

Industry

Registry information

Acronym: CREATE

Important dates

Study start: 2006
Study completion: 2006
First posted: May 31, 2006
Registry last updated: Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed