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NCT00139802 Clinical Trial

DANish Multicenter STENT Trial

Ischemic Heart Disease Clinical 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00139802
Other study ID # DANSTENT
Secondary ID
Status Completed
Phase Phase 4
First received August 30, 2005
Last updated August 30, 2005
Start date April 1997
Est. completion date June 2001

Study information
Verified date January 1997
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial Summary

The purpose of the study was to evaluate procedural and late outcome of coronary artery stenting using 2 different unmounted stents

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date June 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Stable, unstable or silent angina,

- De novo lesion

Exclusion Criteria:

- Allergy to ticlopidine

- Recent myocardial infarction

- Expected survival > 1 year

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Coronary Stent Implantation

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Jørgensen E, Kelbaek H, Helqvist S, Jensen GV, Saunamäki K, Kastrup J, Madsen JK, Kløvgaard 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 — View Citation

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