NCT01300494

Brief Summary

An optimal angiographic viewing angle is critical for correct diagnosis and intervention in coronary bifurcation lesion percutaneous coronary interventions (PCI). The current study aims at validating a dedicated software tool (MEDIS, Leiden, The Netherlands) that will improve the selection of the best viewing angle.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

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

First Submitted

Initial submission to the registry

February 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 21, 2011

Status Verified

February 1, 2011

Enrollment Period

9 months

First QC Date

February 18, 2011

Last Update Submit

February 18, 2011

Conditions

Coronary Bifurcation Lesion

Keywords

bifurcation lesionoptimal viewing angleautomated software

Eligibility Criteria

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

In patients undergoing coronary angiography, those with an angiographically significant bifurcation lesion will be identified. A total of 50 patients will be selected. After diagnostic angiography, optimal viewing angles for the bifurcation lesion will be calculated using the dedicated Medis (Leiden, the Netherlands) software.

You may qualify if:

  • Patient older than 18 years of age
  • Informed consent available

You may not qualify if:

  • Hemodynamic unstability (cardiogenic shock, life-threatening arrhythmias, inotropic support)
  • Impaired renal function (serum creatinine \> 2.0 mg/dl)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 21, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

February 21, 2011

Record last verified: 2011-02