NCT00279006

Brief Summary

This study will evaluate the 3 drug-eluting stents presently marketed for intervention in the coronary artery with respect to the complications that may occur in case it becomes necessary to retract the stent during the intervention. It has been noted that stents carrying a drug for local application may be more difficult to retract than the more smooth bare metal stents.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2006

Shorter than P25 for not_applicable coronary-artery-disease

Status
unknown

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

January 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 19, 2006

Status Verified

January 1, 2006

First QC Date

January 17, 2006

Last Update Submit

January 17, 2006

Conditions

Coronary Artery Disease

Keywords

DES (drug eluting stents)CAD (cornary artery disease)stent retrieval

Outcome Measures

Primary Outcomes (2)

  • In-Hospital mortality, myocardial infarction, or need for unplanned urgent repeat revascularization.

  • Myocardial infarction defined as creatine kinase MB-isoform [CK-MB] ≥3x upper limit of normal within 24 hours of the procedure or ≥2x upper limit of normal after 24 hours of the procedure in the presence of new ischemic symptoms.

Interventions

Percutaneous coronary interventionPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a planned angiography and percutane coronary intervention
  • Age 18 years or above
  • Informed consent to PCI and to participation in this trial

You may not qualify if:

  • Patients who after angiography are deemed not suitable for stent implant (operators discretion)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseaseDysequilibrium syndrome

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Franz R Eberli, MD

    University Hospital, Zürich

    STUDY DIRECTOR

Central Study Contacts

Marco Roffi, MD

CONTACT

+41 44 255 8573marco.roffi@usz.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 17, 2006

First Posted

January 19, 2006

Study Start

January 1, 2006

Study Completion

March 1, 2007

Last Updated

January 19, 2006

Record last verified: 2006-01