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Prognostic Assessment of Different Pattern of Bifurcation Restenosis (LATINA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Ospedale Santa Maria Goretti.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01411475
First Posted: August 8, 2011
Last Update Posted: August 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ospedale Santa Maria Goretti
  Purpose
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.

Condition Intervention
In-stent Coronary Artery Restenosis Other: Bifurcation restenosis classification

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Classification of Bifurcation Restenosis: a Prognostic Assessment

Further study details as provided by Ospedale Santa Maria Goretti:

Primary Outcome Measures:
  • Major adverse cardiac events [ Time Frame: 12 months ]
    Number of patients experiencing any of the following events: cardiac death, non-fatal miocardial infarction, target vessel revascularization


Secondary Outcome Measures:
  • Cardiac death [ Time Frame: 12 ]
    Number of patients experiencing a cardiac death event

  • Non-fatal myocardial infarction [ Time Frame: 12 months ]
    Number of patients experiencing a non-fatal myocardial infarction event

  • Target vessel revascularization [ Time Frame: 12 month ]
    Number of patients experiencing a target vessel revascularization event


Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Bifurcation restenosis
Patients with either a main vessel or a side branch restenosis following succesful percutaneous coronary intervention
Other: Bifurcation restenosis classification
Classification of restenosis involving coronary bifurcation according to their pattern

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Coronary artery disease
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • life expectancy >1 year
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01411475


Contacts
Contact: Gregory A Sgueglia, MD, PhD +3907736556217 g.a.sgueglia@gmail.com

Locations
Italy
S.M. Goretti Recruiting
Latina, Italy, 04100
Contact: Gregory A Sgueglia, MD, PhD    +3907736556217    g.a.sgueglia@gmail.com   
Contact: Daniel Todaro, MD, PhD    3907736556217    todarodaneile@gmail.com   
S.M. Goretti Recruiting
Latina, Italy
Contact: Gregory A Sgueglia, MD, PhD    +3907736556217    g.a.sgueglia@gmail.com   
Contact: Daniel Todaro, MD, PhD    3907736556217    todarodaniel@gmail.com   
Principal Investigator: Gregory A Sgueglia, MD, PhD         
Sub-Investigator: Daniel Daniel, MD, PhD         
Sponsors and Collaborators
Ospedale Santa Maria Goretti
  More Information

Publications:
Responsible Party: Edoardo Pucci, S.M. Goretti
ClinicalTrials.gov Identifier: NCT01411475     History of Changes
Other Study ID Numbers: SMG-009
First Submitted: August 5, 2011
First Posted: August 8, 2011
Last Update Posted: August 8, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases