NCT00192881

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.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

August 18, 2010

Status Verified

July 1, 2010

First QC Date

September 12, 2005

Last Update Submit

August 17, 2010

Conditions

Coronary Artery Disease

Keywords

Percutaneous coronary interventionBalloon angioplastyRestenosisStents

Interventions

Bx Sonic & Cypher stent from CordisDEVICE

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Cardiac Cath Lab

Copenhagen, DK-2100, Denmark

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Henning Kelbaek, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Henning Kelbaek, MD

CONTACT

henning.kelbaek@rh.hosp.dk

Lene Kloevgaard, RN

CONTACT

lene.kloevgaard@rh.hosp.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

October 1, 2002

Last Updated

August 18, 2010

Record last verified: 2010-07

Locations

DK(1)