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ACROSS-Cypher Total Occlusion Study of Coronary Arteries 4 Trial

NCT00378612 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-09-12

No results posted yet for this study

Summary

ACROSS-Cypher® is a prospective, multi-center, open label, single arm study of the Cypher® sirolimus eluting coronary stent in native total coronary occlusion revascularization. The primary endpoint is binary angiographic restenosis at 6 months. The TOSCA-1 trial will be used as the historical control. The hypothesis is that compared with TOSCA-1 patients who were treated with the heparin-coated Palmaz Schatz stent, treatment with the Cypher® sirolimus eluting coronary stent will result in a \>50% relative reduction in 6 month restenosis within the treated segment of the target vessel.

Conditions

  • Coronary Occlusions

Interventions

DEVICE

Cypher sirolimus eluting coronary stent

Cypher® sirolimus eluting coronary stent ranging in diameters 2.5 to 3.5 mm and available in length from 8 to 33 mm.

Sponsors & Collaborators

  • Cordis Corporation

    collaborator INDUSTRY

  • Sunil Rao

    lead OTHER

Principal Investigators

  • Sunil Rao, M.D. · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2007-04-30
Completion
2012-09-30

Countries

  • United States
  • Canada

Study Locations

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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 NCT00378612 on ClinicalTrials.gov