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Completed

NCT Number: NCT00385905

Excel Drug-Eluting Stent Pilot Clinical Registry

The Trial aims to evaluate long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.

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Key information

Conditions

Coronary Stenosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shenyang Nothern Hospital

Shenyang, Liaoning, 110016, China

About this study

30-day, 6-month, and 12-month clinical follow-up and 6 to 9-month IVUS or SCA follow-up to measure long-term efficiency of Excel stent in the inhibition of restenosis as well as the safety after the cessation of the 6-month anti-platelet drug treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who should fulfill with criteria of implanting Excel stents.
  • Each patient enrolled is only allowed to implant Excel stents.
  • Each patient are not allowed to be implanted more than 6 Excel stents.Also, 3 over-lapped stents are not allowed to be implanted in the same vessel(3-5mm overlapping needed; length of stents totally are not allowed to be over 80mm; fully post-dilated is essential for overlapping).
  • Patients acknowlegement to the trial is essential.

Exclusion criteria

  • AMI withine 1 week.
  • Patients who do not suitable to Excel stenting.(For example, non-tolerant to anti-platelet drug or cardiac/non-cardiac surgery undergoing recently.)
  • Patients who have multiple branch lesions can not apply single Excel stenting.
  • Patients who refuse to sign the Trial Acknowledgement.
  • Patients with intra-stent restenosis.

Treatment and study plan

Excel Drug-eluting stent

Device

Primary outcomes

  1. 12-month MACE

Secondary outcomes

  1. 30-day or 6-month MACE

  2. 6 to 9-month restenosis rate by SCA follow-up

Sponsors and collaborators

Lead sponsor

JW Medical Systems Ltd

Industry

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
Oct 11, 2006
Registry last updated
Oct 11, 2006

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.

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