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
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
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014