The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial

This study has been completed.
Sponsor:
Information provided by:
Cook
ClinicalTrials.gov Identifier:
NCT00196079
First received: September 12, 2005
Last updated: January 30, 2012
Last verified: January 2012

September 12, 2005
January 30, 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00196079
506
Not Provided
April Lavender, RAC, Vice President for Regulatory Affairs, Cook
Cook
Not Provided
Principal Investigator: Seung Jung Park, MD Asan Medical Center
Cook
January 2012

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