NCT00225693

Brief Summary

The study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

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

Timeline
Completed

Started Oct 2003

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

October 1, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
Last Updated

February 1, 2012

Status Verified

January 1, 2012

First QC Date

September 12, 2005

Last Update Submit

January 30, 2012

Conditions

Coronary Artery Disease

Keywords

coronary arteryrestenosispatencydrug elutingstent

Outcome Measures

Primary Outcomes (1)

  • Evaluation by IVUS of % diameter stenosis at follow up.

Secondary Outcomes (2)

  • Major adverse events

  • Target lesion revascularization

Interventions

drug eluting coronary stentDEVICE

Eligibility Criteria

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

You may qualify if:

  • Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
  • Patient must be an acceptable candidate for coronary artery bypass surgery
  • Patient or legal guardian must have given informed consent
  • Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status, an IVUS examination and a diagnostic angiogram.

You may not qualify if:

  • Patient must be less than 18 years old
  • Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
  • Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
  • Women of child bearing potential.
  • Patient has other medical condition that any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Sponsor

Bloomington, Indiana, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Joseph Dens, MD

    UZ Gasthuisberg Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 26, 2005

Study Start

October 1, 2003

Study Completion

July 1, 2005

Last Updated

February 1, 2012

Record last verified: 2012-01

Locations

US(1)