V-Flex Plus PTX Drug Eluting Coronary Stent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-07-31

Brief Summary

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The study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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drug eluting coronary stent

Intervention Type DEVICE

Eligibility Criteria

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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 or legal guardian must have given informed consent
* Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status, an IVUS examination and a diagnostic angiogram.

Exclusion Criteria

* Patient must be less than 18 years old
* Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
* 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.
* Women of child bearing potential.
* Patient has other medical condition that any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No