Coronary Artery DiseaserEPIC04FNCT05706805
NAVISCORE PMCF Study ( rEPIC04F )
An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by Fundación EPIC at 7 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Ischemic Heart Disease
- What is being tested?
- Naviscore
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 7 sitesSpain
- Study dates
- 31 Jan 2023to 27 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients treated with Naviscore according to routine hospital practice and following instructions for use
Who may be able to join
- Patient treated with Naviscore according to routine hospital practice and following instructions for use
- Informed consent signed
Who cannot join
- Not meet inclusion criteria
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario de Cáceres
Cáceres, 10003
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005
Hospital Universitario de Leon
León, 24008
Hospital Universitario Lucus Agusti
Lugo, 27003
Hospital Regional Universitario Carlos Haya
Málaga, 29010
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease
- Being tested
- Naviscore
- Keywords
- MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Coronary balloon dilatation catheter
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaviscoreDevice
Patients in whom treatment with (Naviscore) has been attempted
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Disease (CAD) | Not described Receives: Device: Naviscore |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 days
Secondary outcomes (8)
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).
Measured: 7 days
Freedom from Balloon rupture
Freedom from Balloon rupture
Measured: During PCI (Percutaneous Coronary Intervention)
Freedom from Hypotube rupture
Freedom from Hypotube rupture ( partial or total fracture of the shaft of the device)
Measured: 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)
Measured: During PCI (Percutaneous Coronary Intervention)
Freedom from Coronary perforation
Freedom from Coronary perforation according to the modified Ellis classification
Measured: 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)
Measured: 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)
Measured: During PCI (Percutaneous Coronary Intervention)
Freedom from Coronary thrombosis
Freedom from Coronary thrombosis according to ARC-2 ( Academic Research Consortium-2) criteria
Measured: During PCI (Percutaneous Coronary Intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start31 Jan 2023
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706805
- Sponsor's protocol ID
- NAVISCORE PMCF Study
- Acronym
- rEPIC04F
- Status last verified
- Feb 2024
- First submitted
- 15 Nov 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 18174614Weisz 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.
PubMed 22927100US FDA: Summary of Safety and Effectiveness Data (SSED): AngioSculpt®Scoring Balloon Catheter (2007) www.accessdata.fda.gov/cdrh_docs/pdf5/P050018b.pdf
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAVISCORE Post-Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT05706805
- Acronym / sponsor ID
- rEPIC04F / NAVISCORE PMCF Study
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease
- Keywords
- MDR (Medical Device Regulations), PMCF (Post-Market Clinical Follow-up), Coronary balloon dilatation catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease (CAD) | – | Device: Naviscore |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients treated with Naviscore according to routine hospital practice and following instructions for use
Key inclusion criteria (2 listed)
- Patient treated with Naviscore according to routine hospital practice and following instructions for use
- Informed consent signed
Key exclusion criteria (1 listed)
- Not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaviscorePatients in whom treatment with (Naviscore) has been attempted | Device | Coronary Artery Disease (CAD) |
Primary outcome
Safety Endpoint. Freedom from Target Lesion Failure
Time frame: 7 days
Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR).
8 secondary outcomes
Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)
Time frame: 7 days
Freedom from Balloon rupture
Time frame: During PCI (Percutaneous Coronary Intervention)
Freedom from Hypotube rupture
Time frame: During PCI (Percutaneous Coronary Intervention)
Freedom from Complicated withdrawal
Time frame: During PCI (Percutaneous Coronary Intervention)
Freedom from Coronary perforation
Time frame: During PCI (Percutaneous Coronary Intervention)
Freedom from Coronary dissection >C
Time frame: During PCI (Percutaneous Coronary Intervention)
Freedom from No reflow
Time frame: During PCI (Percutaneous Coronary Intervention)
Freedom from Coronary thrombosis
Time frame: During PCI (Percutaneous Coronary Intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 18174614Fonseca 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.
- Background: PubMed 22927100Weisz 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.
- BackgroundUS FDA: Summary of Safety and Effectiveness Data (SSED): AngioSculpt®Scoring Balloon Catheter (2007) www.accessdata.fda.gov/cdrh_docs/pdf5/P050018b.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Ischemic Heart Disease, run by Fundación EPIC at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Endpoint. Freedom from Target Lesion Failure (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05706805, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024; AzTrials last refreshed its copy on 2 Nov 2026.