NAVISCORE PMCF Study ( rEPIC04F )

NCT ID: NCT05706805

Last Updated: 2024-02-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-31

Study Completion Date

2023-09-27

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Ischemic Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary Artery Disease (CAD)

Naviscore

Intervention Type DEVICE

Patients in whom treatment with (Naviscore) has been attempted

Interventions

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Naviscore

Patients in whom treatment with (Naviscore) has been attempted

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación EPIC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitari Vall D'Hebron

Barcelona, , Spain

Site Status

Hospital Clinic de Barcelona

Barcelona, , Spain

Site Status

Hospital Universitario de Cáceres

Cáceres, , Spain

Site Status

Hospital Universitario Juan Ramon Jimenez

Huelva, , Spain

Site Status

Hospital Universitario de Leon

León, , Spain

Site Status

Hospital Universitario Lucus Agusti

Lugo, , Spain

Site Status

Hospital Regional Universitario Carlos Haya

Málaga, , Spain

Site Status

Countries

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Spain

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.

Reference Type BACKGROUND
PMID: 18174614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22927100 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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NAVISCORE PMCF Study

Identifier Type: -

Identifier Source: org_study_id

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