Prognostic Assessment of Different Pattern of Bifurcation Restenosis (LATINA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Ospedale Santa Maria Goretti.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ospedale Santa Maria Goretti
ClinicalTrials.gov Identifier:
NCT01411475
First received: August 5, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Number of patients experiencing a cardiac death event

  • Non-fatal myocardial infarction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of patients experiencing a non-fatal myocardial infarction event

  • Target vessel revascularization [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Sgueglia GA, Todaro G, Stipo A, Pucci E. Simultaneous inflation of two drug-eluting balloons for the treatment of coronary bifurcation restenosis: a concept series. J Invasive Cardiol Accepted.

Responsible Party: Edoardo Pucci, S.M. Goretti
ClinicalTrials.gov Identifier: NCT01411475     History of Changes
Other Study ID Numbers: SMG-009
Study First Received: August 5, 2011
Last Updated: August 5, 2011
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on September 22, 2014