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Excel Drug-Eluting Stent Pilot Clinical Registry

This study has been completed.
Sponsor:
Information provided by:
JW Medical Systems Ltd
ClinicalTrials.gov Identifier:
NCT00385905
First received: October 10, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00385905     History of Changes
Other Study ID Numbers: H-2006-2
Study First Received: October 10, 2006
Last Updated: October 10, 2006
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Stenosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014