Back to resultsDANish Multicenter STENT Trial
Primary Purpose
Ischemic Heart Disease, Stable Angina, Unstable Angina
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Coronary Stent Implantation
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease
Eligibility Criteria
Inclusion Criteria: Stable, unstable or silent angina, De novo lesion Exclusion Criteria: Allergy to ticlopidine Recent myocardial infarction Expected survival > 1 year
Sites / Locations
- Rigshospitalet
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00139802
First Posted
August 30, 2005
Last Updated
August 30, 2005
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00139802
Brief Title
DANish Multicenter STENT Trial
Official Title
Low Restenosis Rate of the NIR Coronary Stent: Results of the Danish Multicenter Stent Study (DANSTENT) - a Randomized Study Comparing a First-Generation With a Second-Generation Stent.
Study Type
Interventional
2. Study Status
Record Verification Date
January 1997
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
5. Study Description
Brief Summary
The purpose of the study was to evaluate procedural and late outcome of coronary artery stenting using 2 different unmounted stents
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Stable Angina, Unstable Angina
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Coronary Stent Implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stable, unstable or silent angina,
De novo lesion
Exclusion Criteria:
Allergy to ticlopidine
Recent myocardial infarction
Expected survival > 1 year
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
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
12595860
Citation
Jorgensen E, Kelbaek H, Helqvist S, Jensen GV, Saunamaki K, Kastrup J, Madsen JK, Klovgaard L, Thuesen L, Villadsen A, van Weert AW, Reiber JH; Danish multicenter stent study (DANSTENT). Low restenosis rate of the NIR coronary stent: results of the Danish multicenter stent study (DANSTENT)--a randomized trial comparing a first-generation stent with a second-generation stent. Am Heart J. 2003 Feb;145(2):e5. doi: 10.1067/mhj.2003.32.
Results Reference
result
Learn more about this trial
DANish Multicenter STENT Trial
We'll reach out to this number within 24 hrs