NAVISCORE PMCF Study ( rEPIC04F )

Coronary Artery Disease Clinical Trial

— rEPIC04F  

Official title:

NAVISCORE Post-Market Clinical Follow-up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05706805
• Other study ID #: NAVISCORE PMCF Study
• Status: Completed
• Start date: January 31, 2023
• Est. completion date: September 27, 2023

Study information

• Verified date: February 2024
• Source: Fundación EPIC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: September 27, 2023
• Est. primary completion date: September 27, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Naviscore
Patients in whom treatment with (Naviscore) has been attempted

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitari Vall D'Hebron	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

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

US FDA: Summary of Safety and Effectiveness Data (SSED): AngioSculpt®Scoring Balloon Catheter (2007) www.accessdata.fda.gov/cdrh_docs/pdf5/P050018b.pdf

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Freedom from Balloon rupture	Freedom from Balloon rupture	During PCI (Percutaneous Coronary Intervention)
Secondary	Freedom from Hypotube rupture	Freedom from Hypotube rupture ( partial or total fracture of the shaft of the device)	During PCI (Percutaneous Coronary Intervention)
Secondary	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)
Secondary	Freedom from Coronary perforation	Freedom from Coronary perforation according to the modified Ellis classification	During PCI (Percutaneous Coronary Intervention)
Secondary	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)
Secondary	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)
Secondary	Freedom from Coronary thrombosis	Freedom from Coronary thrombosis according to ARC-2 ( Academic Research Consortium-2) criteria	During PCI (Percutaneous Coronary Intervention)