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The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00196079
First Posted: September 20, 2005
Last Update Posted: February 1, 2012
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:
Cook Group Incorporated
September 12, 2005
September 20, 2005
February 1, 2012
February 2000
Not Provided
Angiographic in-stent % diameter at follow-up.
Same as current
Complete list of historical versions of study NCT00196079 on ClinicalTrials.gov Archive Site
  • Major adverse events
  • Total lesion revascularization
Same as current
Not Provided
Not Provided
 
The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial
The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial
The ASPECT study is an Asian multicenter, randomized, controlled, triple-blinded study designed to evaluate the ability of the Cook Incorporated Paclitaxel Eluting Supra G Coronary Stent to reduce restenosis in the coronary artery.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Coronary Artery Disease
Device: Coronary stent
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
177
August 2001
Not Provided

Inclusion Criteria:

  • Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
  • Patient must be an acceptable candidate for coronary artery bypass surgery.
  • Patient must have given signed informed consent.
  • Patient agrees to return at one month for an office visit to assess cardiovascular status and at 4-6 months for an office visit to assess cardiovascular status and for a diagnostic angiogram.

Exclusion Criteria:

  • Patient is less than 18 years old.
  • Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • The patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
  • Patient has known hypersensitivity or contraindication to aspirin, Clopidogrel, or stainless steel, or a sensitivity to contrast dye that.
  • Patient is pregnant.
  • Patient has other medical condition that may cause the patient to be non-compliant with the protocol, confound the results or is associated with limited life expectancy.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00196079
506
Not Provided
Not Provided
Not Provided
April Lavender, RAC, Vice President for Regulatory Affairs, Cook
Cook Group Incorporated
Not Provided
Principal Investigator: Seung Jung Park, MD Asan Medical Center
Cook Group Incorporated
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP