Artery DiseaseNCT05902923
Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries
An observational study of Artery Disease, run by iVascular S.L.U. at 6 sites in France.
Trial summary
The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-world population of 209 patients who underwent an endovascular intervention within standard-of-care of the iliacofemoral artery and renal artery, using at least one of the investigational… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Artery Disease
- What is being tested?
- endovascular intervention
- Type of treatment
- Surgery or procedure
- How many people
- 209 participants
- Where
- 6 sitesFrance
- Study dates
- 1 Aug 2023to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Every patient who is eligible for treatment with any of the following devices, can be considered to be included in the study: the Oceanus 18 Balloon Dilatation Catheter and/or the Oceanus 35 Balloon Dilatation Catheter and/or the Luminor 18 Drug Coated Balloon and/or the Luminor 35 Drug Coated Balloon and/or the Restorer Peripheral Stent System and/or the iVolution pro Peripheral Self-Expanding Stent System and/or the iCover Covered Peripheral Stent System and/or the Sergeant Peripheral Support Catheter
Who may be able to join
- Corresponding to the CE-mark indications/contra-indications and according to the IFU of the device.
- Patient is >18 years old.
- Patient understands the nature of the procedure and provides written informed consent prior to enrollment in the study.
- Target lesion(s) is/are located in renal, iliac or femoral arteries.
- Patient is eligible for treatment with the Oceanus 18 Balloon Dilatation Catheter and/or the Oceanus 35 Balloon Dilatation Catheter and/or the Luminor 18 Drug Coated Balloon and/or the Luminor 35 Drug Coated Balloon and/or the Restorer Peripheral Stent System and/or the iVolution pro Peripheral Self-Expanding Stent System and/or the iCover Covered Peripheral Stent System and/or the Sergeant Peripheral Support Catheter as described in IFU for each device.
Who cannot join
- Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices.
- Known contraindication and/or allergy to (a component of) an investigational device.
- Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding.
- Life expectancy of less than 12 months.
- Any planned surgical intervention/procedure within 30 days after the study procedure.
- Any patient considered to be hemodynamically unstable at onset of the procedure.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 5 recruiting
- Active, not recruiting
CH Henri Duffaut
Avignon
- Recruiting
Clinique Synergia Ventoux
Carpentras
Frédéric Verdy
- Recruiting
Polyclinique Inkermann
Niort
Christophe Marchand
- Recruiting
L'Hôpital Privé Des Côtes D'Armor
Plérin
Jean-François Desjardins
- Recruiting
Hôpital d'instruction des Armées Sainte Anne
Toulon
Fabien Beranger
- Recruiting
Hôpital Privé Toulon Hyeres St. Jean
Toulon
Pierre Sarradon
About this study
Official title: A Prospective PMCF Study Investigating the Safety and Clinical Performance of the Oceanus 18 and Oceanus 35 Balloon Dilatation Catheters, the Luminor 18 and Luminor 35 Drug Coated Balloons, the Restorer Peripheral Stent System, the iVolution Pro Peripheral Self-Expanding Stent System, the iCover Covered Peripheral Stent System and the Sergeant Peripheral Support Catheter for Endovascular Interventions.
The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-world population of 209 patients who underwent an endovascular intervention within standard-of-care of the iliacofemoral artery and renal artery, using at least one of the investigational products from iVascular.
- Conditions
- Artery Disease
- Being tested
- endovascular intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular interventionProcedure or surgery
endovascular intervention
| Study group | Role | What they receive |
|---|---|---|
| intervention | All patients in the study will undergo same procedure. The implanted devices can be one of more of the study devices. Receives: Procedure: endovascular intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedeom from SAEs and SADEs (Primary Safety Endpoint)
Freedeom from SAEs and SADEs
Measured: during procedure and up to 2 years after procedure
Technical success rate (Primary Efficacy Endpoint)
Technical success rate defined as ability to cross, introduce and deploy devices based on quantitative scaling by investigators
Measured: during procedure
Secondary outcomes (5)
General physician appraisal of the devices by means of rating scale
General physician appraisal of the devices will be explored based on: 1. Simplicity of handling, 2. Pushability, 3. Trackability, 4. Crossability and 5. Profile
Measured: during procedure
General physician appraisal of the devices by means of rating scale for the Luminor 18, Luminor 35, Oceanus 18 and Oceanus 35
Physician appraisal for the Luminor 18, Luminor 35, Oceanus 18 and Oceanus 35 will be explored based on: 1. Deflation time, 2. Balloon Compliance, 3. Visibility and 4. Balloon refolding
Measured: during procedure
General physician appraisal of the devices by means of rating scale for the Restorer, iVolution pro, iCover
Physician appraisal for the Restorer, iVolution pro, iCover be explored based on: 1. Recoil, 2. Radial force, 3. Ease to canalize the lesion, 4. Stent coverage, 5. Stent graft recrossing and 6. Balloon refusal
Measured: during procedure
General physician appraisal of the devices by means of rating scale for the Sergeant
And physician appraisal for the Sergeant will be explored based on: 1. Trackability over the guide wire, 2. Absence of kinking behaviour, 3. Injection Capacity, 4. Ease of changing guide wires and 5. Ease to canalize the lesion
Measured: during procedure
Explorative endpoint
Freedom from SAEs and SADEs; Freedom from Target Lesion Revascularization
Measured: up to 2 years after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Aug 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 209 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iVascular S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902923
- Sponsor's protocol ID
- FCRE-220209
- Status last verified
- May 2024
- First submitted
- 28 Mar 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective PMCF Study Investigating the Safety and Clinical Performance of the Oceanus 18 and Oceanus 35 Balloon Dilatation Catheters, the Luminor 18 and Luminor 35 Drug Coated Balloons, the Restorer Peripheral Stent System, the iVolution Pro Peripheral Self-Expanding Stent System, the iCover Covered Peripheral Stent System and the Sergeant Peripheral Support Catheter for Endovascular Interventions.
- ClinicalTrials.gov ID
- NCT05902923
- Acronym / sponsor ID
- FCRE-220209
- Conditions
- Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 209 participants (estimated)
- Lead sponsor
- iVascular S.L.U.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 15 Jun 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.
The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-world population of 209 patients who underwent an endovascular intervention within standard-of-care of the iliacofemoral artery and renal artery, using at least one of the investigational products from iVascular.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | – | Procedure: endovascular interventionAll patients in the study will undergo same procedure. The implanted devices can be one of more of the study devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient who is eligible for treatment with any of the following devices, can be considered to be included in the study: the Oceanus 18 Balloon Dilatation Catheter and/or the Oceanus 35 Balloon Dilatation Catheter and/or the Luminor 18 Drug Coated Balloon and/or the Luminor 35 Drug Coated Balloon and/or the Restorer Peripheral Stent System and/or the iVolution pro Peripheral Self-Expanding Stent System and/or the iCover Covered Peripheral Stent System and/or the Sergeant Peripheral Support Catheter
Key inclusion criteria (5 listed)
- Corresponding to the CE-mark indications/contra-indications and according to the IFU of the device.
- Patient is >18 years old.
- Patient understands the nature of the procedure and provides written informed consent prior to enrollment in the study.
- Target lesion(s) is/are located in renal, iliac or femoral arteries.
- Patient is eligible for treatment with the Oceanus 18 Balloon Dilatation Catheter and/or the Oceanus 35 Balloon Dilatation Catheter and/or the Luminor 18 Drug Coated Balloon and/or the Luminor 35 Drug Coated Balloon and/or the Restorer Peripheral Stent System and/or the iVolution pro Peripheral Self-Expanding Stent System and/or the iCover Covered Peripheral Stent System and/or the Sergeant Peripheral Support Catheter as described in IFU for each device.
Key exclusion criteria (6 listed)
- Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices.
- Known contraindication and/or allergy to (a component of) an investigational device.
- Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding.
- Life expectancy of less than 12 months.
- Any planned surgical intervention/procedure within 30 days after the study procedure.
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 |
|---|---|---|
| endovascular interventionendovascular intervention | Procedure or surgery | intervention |
Primary outcome
Freedeom from SAEs and SADEs (Primary Safety Endpoint)
Time frame: during procedure and up to 2 years after procedure
Freedeom from SAEs and SADEs
Technical success rate (Primary Efficacy Endpoint)
Time frame: during procedure
Technical success rate defined as ability to cross, introduce and deploy devices based on quantitative scaling by investigators
5 secondary outcomes
General physician appraisal of the devices by means of rating scale
Time frame: during procedure
General physician appraisal of the devices by means of rating scale for the Luminor 18, Luminor 35, Oceanus 18 and Oceanus 35
Time frame: during procedure
General physician appraisal of the devices by means of rating scale for the Restorer, iVolution pro, iCover
Time frame: during procedure
General physician appraisal of the devices by means of rating scale for the Sergeant
Time frame: during procedure
Explorative endpoint
Time frame: up to 2 years after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Artery Disease, run by iVascular S.L.U. at 6 sites 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mieke Ramsdonck (+32 479 64 37 60, mieke.ramsdonck@fcre.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedeom from SAEs and SADEs (Primary Safety Endpoint) (time frame: during procedure and up to 2 years after 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 8 May 2024.