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Excel Drug-Eluting Stent Pilot Clinical Registry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00385905
First Posted: October 11, 2006
Last Update Posted: October 11, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
JW Medical Systems Ltd
  Purpose
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.

Condition Intervention Phase
Coronary Stenosis Device: Excel Drug-eluting stent Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Excel Drug-Eluting Stent Pilot Clinical Registry

Resource links provided by NLM:


Further study details as provided by JW Medical Systems Ltd:

Primary Outcome Measures:
  • 12-month MACE

Secondary Outcome Measures:
  • 30-day or 6-month MACE
  • 6 to 9-month restenosis rate by SCA follow-up

Estimated Enrollment: 100
Study Start Date: February 2006
Estimated Study Completion Date: January 2007
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385905


Locations
China, Liaoning
Shenyang Nothern Hospital
Shenyang, Liaoning, China, 110016
Sponsors and Collaborators
JW Medical Systems Ltd
Investigators
Study Chair: Yaling Han, Ph.D. Shenyang Northern Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00385905     History of Changes
Other Study ID Numbers: H-2006-2
First Submitted: October 10, 2006
First Posted: October 11, 2006
Last Update Posted: October 11, 2006
Last Verified: October 2006

Additional relevant MeSH terms:
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents