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NCT01411475 Clinical Trial

Prognostic Assessment of Different Pattern of Bifurcation Restenosis

In-stent Coronary Artery Restenosis Clinical Trial

— LATINA  

Official title:
Classification of Bifurcation Restenosis: a Prognostic Assessment

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01411475
Other study ID # SMG-009
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date August 2011
Est. completion date August 2012

Study information
Verified date February 2020
Source Ospedale Santa Maria Goretti
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 2012
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- age >18 years

- restenosis involving a coronary bifurcation previously treated percutaneously

Exclusion Criteria:

- life expectancy >1 year

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Bifurcation restenosis classification
Classification of restenosis involving coronary bifurcation according to their pattern

Locations
Country Name City State
Italy S.M. Goretti Latina
Italy S.M. Goretti Latina

Sponsors (1)
Lead Sponsor Collaborator
Ospedale Santa Maria Goretti

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Cardiac death Number of patients experiencing a cardiac death event 12
Secondary Non-fatal myocardial infarction Number of patients experiencing a non-fatal myocardial infarction event 12 months
Secondary Target vessel revascularization Number of patients experiencing a target vessel revascularization event 12 month
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