NCT05706805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 31, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2023

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

November 15, 2022

Last Update Submit

February 3, 2024

Conditions

Coronary Artery DiseaseIschemic Heart Disease

Keywords

MDR (Medical Device Regulations)PMCF (Post-Market Clinical Follow-up)Coronary balloon dilatation catheter

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)

    7 days

  • Freedom from Balloon rupture

    During PCI (Percutaneous Coronary Intervention)

  • Freedom from Hypotube rupture

    During PCI (Percutaneous Coronary Intervention)

  • Freedom from Complicated withdrawal

    During PCI (Percutaneous Coronary Intervention)

  • Freedom from Coronary perforation

    During PCI (Percutaneous Coronary Intervention)

  • +3 more secondary outcomes

Study Arms (1)

Coronary Artery Disease (CAD)

Device: Naviscore

Interventions

NaviscoreDEVICE

Patients in whom treatment with (Naviscore) has been attempted

Coronary Artery Disease (CAD)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario de Cáceres

Cáceres, 10003, Spain

Location

Hospital Universitario Juan Ramon Jimenez

Huelva, 21005, Spain

Location

Hospital Universitario de Leon

León, 24008, Spain

Location

Hospital Universitario Lucus Agusti

Lugo, 27003, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, 29010, Spain

Location

Related 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.

    PMID: 18174614BACKGROUND

  • 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.

    PMID: 22927100BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2022

First Posted

January 31, 2023

Study Start

January 31, 2023

Primary Completion

September 27, 2023

Study Completion

September 27, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations

ES(7)