The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial

Coronary Artery Disease Clinical Trial

Official title:

The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196079
• Other study ID #: 506
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: January 30, 2012
• Start date: February 2000
• Est. completion date: August 2001

Study information

• Verified date: January 2012
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: August 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Coronary stent

Locations

Country	Name	City	State
United States	Contact Sponsor	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic in-stent % diameter at follow-up.
Secondary	Major adverse events
Secondary	Total lesion revascularization