NAVISCORE PMCF Study ( rEPIC04F ) (rEPIC04F)

NAVISCORE Post-Market Clinical Follow-up Study

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Ischemic Heart Disease
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

• Study Contact: Name: FUNDACION EPIC; Phone Number: 0034987225638; Email: iepic@fundacionepic.org
• Study Contact Backup: Name: FUNDACION EPIC; Phone Number: 0034987225638; Email: admin@fundacionepic.org

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Cáceres, Spain, 10003
    • Hospital Universitario de Cáceres
  • Huelva, Spain, 21005
    • Hospital Universitario Juan Ramon Jimenez
  • León, Spain, 24008
    • Hospital Universitario de Leon
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Agusti
  • Málaga, Spain, 29010
    • Hospital Regional Universitario Carlos Haya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with Naviscore according to routine hospital practice and following instructions for use

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronary Artery Disease (CAD)	Device: Naviscore; Patients in whom treatment with (Naviscore) has been attempted

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint. Freedom from Target Lesion Failure	Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR).	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)	Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).	7 days
Freedom from Balloon rupture	Freedom from Balloon rupture	During PCI (Percutaneous Coronary Intervention)
Freedom from Hypotube rupture	Freedom from Hypotube rupture ( partial or total fracture of the shaft of the device)	During PCI (Percutaneous Coronary Intervention)
Freedom from Complicated withdrawal	Freedom from Complicated withdrawal (difficult or impossible device retrieval that may or may not cause clinical complications)	During PCI (Percutaneous Coronary Intervention)
Freedom from Coronary perforation	Freedom from Coronary perforation according to the modified Ellis classification	During PCI (Percutaneous Coronary Intervention)
Freedom from Coronary dissection >C	Freedom from Coronary dissection >C according to the NHLBI Classification (National Heart, Lung, and Blood Institute)	During PCI (Percutaneous Coronary Intervention)
Freedom from No reflow	Freedom from No reflow (persistently slowed flow with residual stenosis <30% and no flow-limiting dissection)	During PCI (Percutaneous Coronary Intervention)
Freedom from Coronary thrombosis	Freedom from Coronary thrombosis according to ARC-2 ( Academic Research Consortium-2) criteria	During PCI (Percutaneous Coronary Intervention)

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Actual): September 27, 2023
• Study Completion (Actual): September 27, 2023

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: MDR (Medical Device Regulations); PMCF (Post-Market Clinical Follow-up); Coronary balloon dilatation catheter
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: NAVISCORE PMCF Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No