Ischemic Heart DiseasePhase 4NCT00139802
DANish Multicenter STENT Trial
A Phase 4 study testing Coronary Stent Implantation in people with Ischemic Heart Disease and Stable Angina, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of the study was to evaluate procedural and late outcome of coronary artery stenting using 2 different unmounted stents Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Stable Angina, Unstable Angina
- What is being tested?
- Coronary Stent Implantation
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 1997to Jun 2001
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable, unstable or silent angina,
- De novo lesion
Who cannot join
- Allergy to ticlopidine
- Recent myocardial infarction
- Expected survival > 1 year
Trial locations and contacts
1 site in 1 country.
About this study
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.
The purpose of the study was to evaluate procedural and late outcome of coronary artery stenting using 2 different unmounted stents
- Conditions
- Ischemic Heart Disease, Stable Angina, Unstable Angina
- Being tested
- Coronary Stent Implantation
- Medical subject headings
- Myocardial Ischemia, Angina, Stable, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Stent ImplantationDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startApr 1997
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Henning Kelbaek, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139802
- Sponsor's protocol ID
- DANSTENT
- Status last verified
- Jan 1997
- First submitted
- 30 Aug 2005
- Last updated
- 31 Aug 2005
- Results posted
- No
Publications
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.
PubMed 12595860