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Sirolimus-eluting vs Zotarolimus-eluting Stents for Chronic Total Coronary Occlusions

NCT00428454 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2015-06-04

No results posted yet for this study

Summary

Primary intracoronary stent placement after successfully crossing chronic total coronary occlusions (CTO) decreases the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. Several studies have shown the efficacy of sirolimus-eluting stents in selected groups of patients. In the PRISON II study we demonstrated that sirolimus-eluting stents were superior to bare metal stents in CTO. In this prospective randomized trial, sirolimus-stent implantation will be compared with zotarolimus-eluting stent implantation for the treatment of chronic total coronary occlusions. A total of 300 patients will be clinically followed up for 1, 6, 12 months, 2, 3, 4, 5 year with angiographic follow-up at 8 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point is in-segment late luminal loss at 8 month angiographic follow-up.

Conditions

Interventions

DEVICE

sirolimus-eluting stent, zotarolimus-eluting stent

PCI in chronically occluded coronary artery

Sponsors & Collaborators

  • Cordis Corporation

    collaborator INDUSTRY

  • R&D Cardiologie

    lead OTHER

Principal Investigators

  • Maarten J. Suttorp, MD, PhD · St. Antonius Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2010-12-31
Completion
2015-06-30

Countries

  • Belgium
  • Netherlands

Study Locations

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 NCT00428454 on ClinicalTrials.gov