Prognostic Assessment of Different Pattern of Bifurcation Restenosis (LATINA)
This study is currently recruiting participants.
Verified August 2011 by Ospedale Santa Maria Goretti
Sponsor:
Ospedale Santa Maria Goretti
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
| Tracking Information | |||||
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| First Received Date ICMJE | August 5, 2011 | ||||
| Last Updated Date | August 5, 2011 | ||||
| Start Date ICMJE | August 2011 | ||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prognostic Assessment of Different Pattern of Bifurcation Restenosis | ||||
| Official Title ICMJE | Classification of Bifurcation Restenosis: a Prognostic Assessment | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Coronary artery disease |
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| Condition ICMJE | In-stent Coronary Artery Restenosis | ||||
| Intervention ICMJE | Other: Bifurcation restenosis classification
Classification of restenosis involving coronary bifurcation according to their pattern |
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| Study Group/Cohort (s) | Bifurcation restenosis
Patients with either a main vessel or a side branch restenosis following succesful percutaneous coronary intervention
Intervention: Other: Bifurcation restenosis classification |
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| 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | August 2012 | ||||
| Estimated Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01411475 | ||||
| Other Study ID Numbers ICMJE | SMG-009 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Edoardo Pucci, S.M. Goretti | ||||
| Study Sponsor ICMJE | Ospedale Santa Maria Goretti | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Ospedale Santa Maria Goretti | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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