Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease

August 17, 2010 updated by: Rigshospitalet, Denmark

Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease. A Randomised Comparison of Optimal Balloon Angioplasty and Primary Implantation of Stents With and Without Drug Elution in Complex Coronary Lesions

The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary intervention.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Rigshospitalet, Cardiac Cath Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stable, or unstable angina and/or objective signs of myocardial ischaemia
  • Informed consent
  • Optimal result (< 35% residual stenosis and < type C dissection) after balloon angioplasty
  • Lesions should be de novo and located in native vessels with a diameter > 2.25 mm.

  • Complex lesions to be included should have at least one of the following characteristics:

    • ostial in location (< 5 mm from ostium)
    • total occlusions with a length ≥ 15 mm
    • bifurcational (side branch > 1.75 mm in diameter)
    • angulated (> 45° within lesion)

Exclusion criteria:

Patients:

  • Other severe disease with an expected survival < 1 year
  • Other significant cardiac disease
  • Known allergy against paclitaxel, clopidogrel (or ticlopidine),
  • Myocardial infarction within 3 days of the index procedure
  • Linguistic difficulties needing an interpreter
  • Renal insufficiency (p-creatinine > 200 micromol/l)
  • Gastrointestinal bleeding within 1 month
  • Childbearing potential or pregnancy
  • Participation in another study

Lesions:

  • Unprotected left main disease
  • Restenosis
  • Lesions containing visible thrombus
  • Treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure
  • Diffuse coronary disease distal to the treated lesion
  • Heavily calcification
  • Lesion located in saphenous vein graft

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Henning Kelbaek, MD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

August 18, 2010

Last Update Submitted That Met QC Criteria

August 17, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCANDSTENT A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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