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A Prospective Evaluation in a Randomized Trial of TAXUS in the Treatment of De Novo Coronary Artey Lesions

NCT00693979 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2008-06-09

No results posted yet for this study

Summary

This study is to compare the safety and performance of two stents coated with the same drug (the TAXUS Element Paclitaxel-Eluting Coronary Stent System and the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System).

Conditions

Interventions

DEVICE

TAXUS Element Stent or TAXUS Express Stent

Paclitaxel was selected as the drug to coat the stent because it is known to prevent the uncontrolled cell growth that contributes to the narrowing of artery, by interfering with the ability of cells to divide and multiply. Because of these properties, it has been used as a drug for the treatment of various types of cancer. Cancer patients are given paclitaxel as a solution into the vein. For this study, paclitaxel will be administered locally to the wall of coronary artery as a coating on the stent. Cancer patients receive a dose of paclitaxel approximately 1100 - 1400 times greater than the dose used in the coating of the stent. It is highly unlikely that levels of paclitaxel in the blood would be measurable or have effects anywhere beyond the heart.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • National University Hospital, Singapore

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00693979 on ClinicalTrials.gov