Clinical trial NCT05706805: NAVISCORE PMCF Study ( rEPIC04F )
Official title: NAVISCORE Post-Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Keywords: MDR (Medical Device Regulations)
PMCF (Post-Market Clinical Follow-up)
Coronary balloon dilatation catheter
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with Naviscore according to routine hospital practice and following instructions for use

Brief summary: Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Naviscore scoring balloon to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Naviscore.

Detailed description: The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Naviscore scoring balloon in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

Eligibility criteria: Inclusion Criteria:

* Patient treated with Naviscore according to routine hospital practice and following instructions for use
* Informed consent signed

Exclusion Criteria:

• Not meet inclusion criteria

Primary outcomes:
measure: Safety Endpoint. Freedom from Target Lesion Failure
timeFrame: 7 days
Secondary outcomes:
measure: Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)
timeFrame: 7 days
measure: Freedom from Balloon rupture
timeFrame: During PCI (Percutaneous Coronary Intervention)
measure: Freedom from Hypotube rupture
timeFrame: During PCI (Percutaneous Coronary Intervention)
measure: Freedom from Complicated withdrawal
timeFrame: During PCI (Percutaneous Coronary Intervention)
measure: Freedom from Coronary perforation
timeFrame: During PCI (Percutaneous Coronary Intervention)
measure: Freedom from Coronary dissection >C
timeFrame: During PCI (Percutaneous Coronary Intervention)
measure: Freedom from No reflow
timeFrame: During PCI (Percutaneous Coronary Intervention)
measure: Freedom from Coronary thrombosis
timeFrame: During PCI (Percutaneous Coronary Intervention)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Cáceres
country: Spain
facility: Hospital Universitario de Cáceres
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez
city: León
country: Spain
facility: Hospital Universitario de Leon
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Agusti
city: Málaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
Study officials:
References:
citation: 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.
citation: 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.
citation: US FDA: Summary of Safety and Effectiveness Data (SSED): AngioSculpt®Scoring Balloon Catheter (2007) www.accessdata.fda.gov/cdrh_docs/pdf5/P050018b.pdf