Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions

Coronary Stenosis Clinical Trial

Official title: TAXUS V: De Novo Lesion: A Randomized, Double-blind Trial to Assess TAXUS Paclitaxel-Eluting Coronary Stents, SR Formulation, in the Treatment of De Novo Coronary Lesions

Status Completed

Clinical Trial Summary

The primary objective of this study is to further evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in long lesion lengths, small and large vessel diameters and with multiple overlapping stents in the treatment of de novo coronary artery lesions

Clinical Trial Description

The primary endpoint is the incidence rate of TVR through 9 months post index procedure. In this protocol, TVR must be ischemia driven, based on the presence of symptoms, positive functional testing or Quantitative Coronary Angiography (QCA) severity of restenosis.

Secondary endpoints include the following:

• Incidence rates of composite MACE and the individual components of MACE assessed at discharge, 1, 4 and 9 months post index procedure and annually for 5 years (i.e., 1, 2, 3, 4 and 5 years post index procedure).

• Stent thrombosis rate.

• TVF.

• Clinical procedural success and technical success.

• Binary restenosis rate.

• Additional angiographic endpoints to be measured in all patients with 9 month angiographic follow-up include:

• Absolute lesion length

• Reference Vessel Diameter (RVD)

• Minimum Lumen Diameter (MLD)

• Percent diameter stenosis (% DS)

• Acute gain

• Late loss

• Loss index

• Patterns of recurrent restenosis, including edge effect

• Coronary aneurysm

• IVUS Substudy

• Identification of potential safety issues, i.e., incomplete stent apposition.

• change in neointimal volume from post procedure to follow-up

• change in MLD within stent

• minimum lumen area (MLA) within stent

• lumen, plaque and vessel measurements at the stent edges (outside stent) ;

Study Design

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

Related Conditions & MeSH terms

• Coronary Stenosis

• NCT number: NCT00301522
• Study type: Interventional
• Source: Boston Scientific Corporation
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2003
• Completion date: April 2009