NCT00139802

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 1997

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
Last Updated

August 31, 2005

Status Verified

January 1, 1997

First QC Date

August 30, 2005

Last Update Submit

August 30, 2005

Conditions

Ischemic Heart DiseaseStable AnginaUnstable Angina

Interventions

Coronary Stent ImplantationDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable, unstable or silent angina,
  • De novo lesion

You may not qualify if:

  • Allergy to ticlopidine
  • Recent myocardial infarction
  • Expected survival \> 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Copenhagen, DK-2100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 12595860RESULT

MeSH Terms

Conditions

Myocardial IschemiaAngina, StableAngina, Unstable

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Henning Kelbaek, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2005

First Posted

August 31, 2005

Study Start

April 1, 1997

Study Completion

June 1, 2001

Last Updated

August 31, 2005

Record last verified: 1997-01

Locations

DK(1)