Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein GraftsNCT05536167
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters Family
An observational study of Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts, 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 Aspiration catheters family during percutaneous intervention and/or stenting procedure of vessels in the central and peripheral circulation system, including saphenous vein grafts, to support MDR submission. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2022to 31 Dec 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing PTA/PTCA and/or stenting procedures and presenting thrombus in the central and peripheral circulatory system, including saphenous vein grafts.
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, saphenous vein graft, or peripheral arteries;
- Patient with angiographic evidence of thrombus;
- Patient > or = 50 kg;
- 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, also if there 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 Aspiration catheters family during percutaneous intervention and/or stenting procedure of vessels in the central and peripheral circulation system, including saphenous vein grafts, to support MDR submission.
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy endpoint
successful debris aspiration (macroscopic observation of the retrieved material in the filter) during the procedure.
Measured: up to end of procedure
Safety endpoint
insertion and retrieval of the catheter up to the treated vessel without complication.
Measured: up to end of procedure
Secondary outcomes (6)
Performance - TIMI flow grade
Final Thrombolysis In Myocardial Infarction (TIMI) Flow Grade at procedure
Measured: up to end of procedure
Safety - absence of complications
Absence of complications during hospitalization (per standard hospital of care): cardiovascular death, recurrent myocardial infarction, cardiogenic shock, worsening of TIMI flow due to aspiration catheter, new or worsening New York Heart Association (NYHA) Class IV heart failure,
Measured: up to end of procedure
Performance - TIMI thrombus grade
Final TIMI Thrombus Grade at procedure
Measured: up to end of procedure
Performance
Distal Embolization Rate at procedure
Measured: up to end of procedure
Safety - absence of Serious Adverse Event
Incident of Device Related SAEs during aspiration catheter use
Measured: up to end of procedure
Safety - absence of stroke
Stroke during aspiration catheter use (per hospital standard of care).
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 start12 Dec 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein GraftsStudies 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthesys
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536167
- Sponsor's protocol ID
- ART-ASPI CATHETER-01
- Status last verified
- Jan 2024
- First submitted
- 7 Sep 2022
- Last updated
- 1 Feb 2024
- 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 1 Feb 2024. 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 Aspiration Catheters Family
- ClinicalTrials.gov ID
- NCT05536167
- Acronym / sponsor ID
- ART-ASPI CATHETER-01
- Conditions
- Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- ArthesysIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 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 Aspiration catheters family during percutaneous intervention and/or stenting procedure of vessels in the central and peripheral circulation system, including saphenous vein grafts, to support MDR submission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing PTA/PTCA and/or stenting procedures and presenting thrombus in the central and peripheral circulatory system, including saphenous vein grafts.
Key inclusion criteria (6 listed)
- Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP):
Key exclusion criteria (1 listed)
- Patients will be excluded as per IFU, Hospital standard of care and GCP, also if there 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
successful debris aspiration (macroscopic observation of the retrieved material in the filter) during the procedure.
Safety endpoint
Time frame: up to end of procedure
insertion and retrieval of the catheter up to the treated vessel without complication.
6 secondary outcomes
Performance - TIMI flow grade
Time frame: up to end of procedure
Safety - absence of complications
Time frame: up to end of procedure
Performance - TIMI thrombus grade
Time frame: up to end of procedure
Performance
Time frame: up to end of procedure
Safety - absence of Serious Adverse Event
Time frame: up to end of procedure
Safety - absence of stroke
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 1 Feb 2024.
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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 Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts, 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 6 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 1 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 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 1 Feb 2024.