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The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial

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.
ClinicalTrials.gov Identifier: NCT00196079
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 1, 2012
Information provided by:
Cook Group Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: Coronary stent

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial
Study Start Date : February 2000
Estimated Study Completion Date : August 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Primary Outcome Measures :
  1. Angiographic in-stent % diameter at follow-up.

Secondary Outcome Measures :
  1. Major adverse events
  2. Total lesion revascularization

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00196079

United States, Indiana
Contact Sponsor
Bloomington, Indiana, United States
Sponsors and Collaborators
Cook Group Incorporated
Principal Investigator: Seung Jung Park, MD Asan Medical Center

Responsible Party: April Lavender, RAC, Vice President for Regulatory Affairs, Cook
ClinicalTrials.gov Identifier: NCT00196079     History of Changes
Other Study ID Numbers: 506
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: February 1, 2012
Last Verified: January 2012

Keywords provided by Cook Group Incorporated:
coronary artery
drug eluting stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action