Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
54 participants
OBSERVATIONAL
2023-01-31
2023-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Coronary Artery Disease (CAD)
Naviscore
Patients in whom treatment with (Naviscore) has been attempted
Interventions
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Naviscore
Patients in whom treatment with (Naviscore) has been attempted
Eligibility Criteria
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Inclusion Criteria
* Informed consent signed
18 Years
ALL
No
Sponsors
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Fundación EPIC
OTHER
Responsible Party
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Locations
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Hospital Universitari Vall D'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario de Cáceres
Cáceres, , Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, , Spain
Hospital Universitario de Leon
León, , Spain
Hospital Universitario Lucus Agusti
Lugo, , Spain
Hospital Regional Universitario Carlos Haya
Málaga, , Spain
Countries
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References
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Fonseca A, Costa Jde R Jr, Abizaid A, Feres F, Abizaid AS, Costa R, Staico R, Mattos LA, Sousa AG, Grube E, Sousa JE. Intravascular ultrasound assessment of the novel AngioSculpt scoring balloon catheter for the treatment of complex coronary lesions. J Invasive Cardiol. 2008 Jan;20(1):21-7.
Weisz G, Metzger DC, Liberman HA, O'Shaughnessy CD, Douglas JS Jr, Turco MA, Mehran R, Gershony G, Leon MB, Moses JW. A provisional strategy for treating true bifurcation lesions employing a scoring balloon for the side branch: final results of the AGILITY trial. Catheter Cardiovasc Interv. 2013 Sep 1;82(3):352-9. doi: 10.1002/ccd.24630. Epub 2013 Mar 9.
US FDA: Summary of Safety and Effectiveness Data (SSED): AngioSculpt®Scoring Balloon Catheter (2007) www.accessdata.fda.gov/cdrh_docs/pdf5/P050018b.pdf
Other Identifiers
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NAVISCORE PMCF Study
Identifier Type: -
Identifier Source: org_study_id
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