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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Bx Sonic & Cypher stent from Cordis
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous coronary intervention, Balloon angioplasty, Restenosis, Stents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet, Cardiac Cath Lab

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
August 17, 2010
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00192881
Brief Title
Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Percutaneous coronary intervention, Balloon angioplasty, Restenosis, Stents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Bx Sonic & Cypher stent from Cordis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Henning Kelbaek, MD
Email
henning.kelbaek@rh.hosp.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lene Kloevgaard, RN
Email
lene.kloevgaard@rh.hosp.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Kelbaek, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet, Cardiac Cath Lab
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henning Kelbaek, MD
Email
henning.kelbaek@rh.hosp.dk

12. IPD Sharing Statement

Learn more about this trial

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

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