NCT00429052

Brief Summary

The main objectives of this study are define frequency of plaque shift phenomenon and impact on flow dynamics in the side branch as assessed by intravascular ultrasound, and evaluate acute and late side branch ostial vessel reaction to balloon angioplasty and drug-eluting stents.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

March 7, 2012

Status Verified

January 1, 2007

First QC Date

January 30, 2007

Last Update Submit

March 6, 2012

Conditions

Coronary Disease

Keywords

Coronary DiseaseCoronary StenosisPercutaneous Transluminal Coronary AngioplastyStentsSirolimus

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

from cathet labs

You may qualify if:

  • Male or female patient between 18-80 years of age
  • Patients with a sign and/or symptoms of ischemia and new de novo lesion
  • Lesion suitable for stenting
  • Any bifurcation lesion with SB reference diameter(QCA) \>2.3mm (MEDINA classification: 1,0,0; 0,1,0; 0,0,1; 1,1,0; 1,1,1; 0,1,1; 1,0,1)
  • Only elective procedures
  • Patient is willing to provide written informed consent

You may not qualify if:

  • Patients treated within 72h of acute coronary syndromes (ST and non-ST elevation MI).
  • Cardiogenic shock
  • Lesion containing thrombus
  • Total vessel occlusion involving the target vessels
  • Contraindication for prolonged antiplatelet treatment
  • Left main disease, venous or arterial graft disease
  • Debulking technique used prior to the stent implantation
  • Pregnancy
  • Severe liver or renal disease (Cr\>2.0)
  • Life expectancy \< 1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Health Science Center, Cardiovascular Imaging Core Laboratories

Jacksonville, Florida, 32209, United States

Location

MeSH Terms

Conditions

Coronary DiseaseCoronary Stenosis

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Marco A Costa, MD, PhD

    University of Florida Shands Jacksonville, Division of Cardiology and Cardiovascular Imaging Core Laboratories

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2007

First Posted

January 31, 2007

Study Start

November 1, 2006

Study Completion

September 1, 2008

Last Updated

March 7, 2012

Record last verified: 2007-01

Locations

US(1)