Coronary Artery StenosisNCT05536180
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family
An observational study of Coronary Artery Stenosis, run by Arthesys at 1 site in France.
Trial summary
The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Stenosis
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2023to 25 Jul 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients undergoing PTCA procedure
Who may be able to join
- Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP):
- Patient with a Percutaneous intervention to a native coronary or coronary bypass graft indication
- Patient >18 years
- Patient who understands the trial requirements and the treatment procedures and provides written informed consent
Who cannot join
- Patients will be excluded as per IFU, Hospital standard of care and GCP. Patients will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.
- Conditions
- Coronary Artery Stenosis
- Medical subject headings
- Coronary Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy endpoint
Balloon successfully reaching and crossing target location, successful inflation, deflation, and retrieval in the guiding catheter
Measured: up to end of procedure
Safety endpoint
Successful balloon dilatation without device related adverse event during the dilatation procedure
Measured: up to end of procedure
Secondary outcomes (2)
Performance - Pre-dilatation
Residual stenosis < 50% and TIMI flow grade 3 (corelab assessment)
Measured: up to end of procedure
Performance - post-dilatation
Angiographic success of the device defined as < 30% residual stenosis after angiography (corelab assessment)
Measured: up to end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start6 Mar 2023
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery StenosisStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthesys
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536180
- Sponsor's protocol ID
- ART-PTCA-02
- Status last verified
- Nov 2023
- First submitted
- 7 Sep 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family
- ClinicalTrials.gov ID
- NCT05536180
- Acronym / sponsor ID
- ART-PTCA-02
- Conditions
- Coronary Artery Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ArthesysIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 10 Sep 2022 (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.
The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing PTCA procedure
Key inclusion criteria (4 listed)
- Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP):
- Patient with a Percutaneous intervention to a native coronary or coronary bypass graft indication
- Patient >18 years
- Patient who understands the trial requirements and the treatment procedures and provides written informed consent
Key exclusion criteria (1 listed)
- Patients will be excluded as per IFU, Hospital standard of care and GCP. Patients will not be included if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy endpoint
Time frame: up to end of procedure
Balloon successfully reaching and crossing target location, successful inflation, deflation, and retrieval in the guiding catheter
Safety endpoint
Time frame: up to end of procedure
Successful balloon dilatation without device related adverse event during the dilatation procedure
2 secondary outcomes
Performance - Pre-dilatation
Time frame: up to end of procedure
Performance - post-dilatation
Time frame: up to end of procedure
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 22 Nov 2023.
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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.
1 site 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 Stenosis, run by Arthesys at 1 site in France.
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 4 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 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Efficacy endpoint (time frame: up to end of procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2023.