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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
History of Changes
  Purpose

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 Intervention
Coronary Artery Disease
 Device: Coronary stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial

Resource links provided by NLM:

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

Further study details as provided by Cook:

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

Secondary Outcome Measures:
  • Major adverse events
  • Total lesion revascularization

Estimated Enrollment: 177
Study Start Date: February 2000
Estimated Study Completion Date: August 2001
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196079

Locations
United States, Indiana
Contact Sponsor
Bloomington, Indiana, United States
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Seung Jung Park, MD Asan Medical Center
  More Information

No publications provided

Responsible Party: April Lavender, RAC, Vice President for Regulatory Affairs, Cook
ClinicalTrials.gov Identifier: NCT00196079     History of Changes
Other Study ID Numbers: 506
Study First Received: September 12, 2005
Last Updated: January 30, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Cook:
coronary artery
stenosis
drug eluting stent
stent

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

ClinicalTrials.gov processed this record on October 16, 2012