NCT01411475

Brief Summary

The LATINA registry aims at assessing a new classification of bifurcation restenosis in the prediction of major adverse cardiac events in patients who have previously undergone a succesful percutaneous bifurcation intervention.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2011

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

August 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

Same day

First QC Date

August 5, 2011

Last Update Submit

February 21, 2020

Conditions

In-stent Coronary Artery Restenosis

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

    Number of patients experiencing any of the following events: cardiac death, non-fatal miocardial infarction, target vessel revascularization

    12 months

Secondary Outcomes (3)

  • Cardiac death

    12

  • Non-fatal myocardial infarction

    12 months

  • Target vessel revascularization

    12 month

Study Arms (1)

Bifurcation restenosis

Patients with either a main vessel or a side branch restenosis following succesful percutaneous coronary intervention

Other: Bifurcation restenosis classification

Interventions

Bifurcation restenosis classificationOTHER

Classification of restenosis involving coronary bifurcation according to their pattern

Bifurcation restenosis

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Coronary artery disease

You may qualify if:

  • age \>18 years
  • restenosis involving a coronary bifurcation previously treated percutaneously

You may not qualify if:

  • life expectancy \>1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

S.M. Goretti

Latina, 04100, Italy

Location

S.M. Goretti

Latina, Italy

Location

Related Publications (1)

  • Sgueglia GA, Todaro D, Stipo A, Pucci E. Simultaneous inflation of two drug-eluting balloons for the treatment of coronary bifurcation restenosis: a concept series. J Invasive Cardiol. 2011 Nov;23(11):474-6.

    PMID: 22045082BACKGROUND
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 8, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2012

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

IT(2)