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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Rigshospitalet, Denmark.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00192881
First received: September 12, 2005
Last updated: August 17, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Device: Bx Sonic & Cypher stent from Cordis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Study Start Date: October 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192881

Contacts
Contact: Henning Kelbaek, MD henning.kelbaek@rh.hosp.dk
Contact: Lene Kloevgaard, RN lene.kloevgaard@rh.hosp.dk

Locations
Denmark
Rigshospitalet, Cardiac Cath Lab Recruiting
Copenhagen, Denmark, DK-2100
Contact: Henning Kelbaek, MD       henning.kelbaek@rh.hosp.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Henning Kelbaek, MD Rigshospitalet, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00192881     History of Changes
Other Study ID Numbers: SCANDSTENT A
Study First Received: September 12, 2005
Last Updated: August 17, 2010
Health Authority: Denmark: National Board of Health

Keywords provided by Rigshospitalet, Denmark:
Percutaneous coronary intervention
Balloon angioplasty
Restenosis
Stents

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014