Peripheral Arterial Disease Below The KneePOP-BTKNCT05267548
Investigating the Safety and Clinical Performance of Seven iVascular Devices for Endovascular Intervention in the Popliteal and/or Infrapopliteal Arteries
An observational study of Peripheral Arterial Disease Below The Knee, run by iVascular S.L.U. at 8 sites in Belgium.
Trial summary
The rationale of this study is to confirm and support the clinical safety and performance of the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Catheters, the Luminor 14m and Luminor 18 Drug Coated Balloons, the Angiolite BTK Sirolimus Eluting Peripheral Stent System and the Sergeant Peripheral Support Catheter in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease Below The Knee
- How many people
- 143 participants
- Where
- 8 sitesBelgium
- Study dates
- 30 May 2022to May 2025
- How long will I take part?
- 2 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: In this PMCF minimally invasive medical devices with special dedication towards the interventional cardiovascular field will be used. Indications for which the investigational devices are intended are listed in the protocol. Patients will be selected based on the investigator's assessment and evaluation of the underlying disease. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required assessment or from completing the study. Patients should be geographically stable, willing and able to cooperate in this clinical study, and remain available follow-up.
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 enrolment in the study.
- Target lesion(s) is/are located in the popliteal or infrapopliteal arteries
- Patient is eligible for treatment with the Oceanus 14pro Balloon Catheter and/or the Oceanus 18 Balloon Catheter and/or the Oceanus 35 Balloon Catheter and/or the Luminor 14m DCB and/or the Luminor 18 DCB and/or the Angiolite BTK Sirolimus Eluting Peripheral Stent System and/or the Sergeant Peripheral Support Catheter as described in the 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 procedure.
Trial locations and contacts
8 sites in 1 country.
Mieke Ramsdonck contact
8 sites in 1 country
Belgium8 sites, 8 recruiting
- Recruiting
Imelda Bonheiden
Bonheiden
Dr. Verbist
- Recruiting
Jessa Hasselt
Hasselt
Dr. Lacquet
- Recruiting
Az Groeninge Kortrijk
Kortrijk
Dr. Lerut
- Recruiting
Az Sint Maarten Mechelen
Mechelen
Dr. Noyéz
- Recruiting
HH Mol
Mol
Dr. Berghmans
- Recruiting
Az Damiaan Oostende
Ostend
Dr. Schepers
- Recruiting
RZ Tienen
Tienen
Dr. Keirse
- Recruiting
Az Jan Portaels Vilvoorde
Vilvoorde
Dr. Robijn
About this study
Official title: A Prospective PMCF Study Investigating the Safety and Clinical Performance of the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Catheters, the Luminor 14m and Luminor 18 Drug Coated Balloons, the Angiolite BTK Sirolimus Eluting Peripheral Stent System and the Sergeant Peripheral Support Catheter for the Endovascular Intervention in Popliteal and Infrapopliteal Arteries
The rationale of this study is to confirm and support the clinical safety and performance of the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Catheters, the Luminor 14m and Luminor 18 Drug Coated Balloons, the Angiolite BTK Sirolimus Eluting Peripheral Stent System and the Sergeant Peripheral Support Catheter in a real-word population of 143 patients who underwent an endovascular intervention the popliteal and/or infrapopliteal arteries within standard-of-care (SOC) where at least 1 of the investigational products from iVascular were used.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: Freedom from SAE/SADE
Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) during the procedure and up to 2 years after the procedure (depending on the device that was used).
Measured: 2 years
Primary Efficacy Endpoint: Technical success
Technical success rate defined as successful crossing, introduction and deployment of the Oceanus 14pro Balloon Catheter and/or the Oceanus 18 Balloon Catheter and/or the Oceanus 35 Balloon Catheter and/or the Luminor 14m DCB and/or the Luminor 18 DCB and/or the Angiolite BTK Sirolimus Eluting Peripheral Stent System and/or the Sergeant Peripheral Support Catheter according to the respective IFU and without device related deficiencies.
Measured: During procedure
Secondary outcomes (4)
Physician Appraisal
General physician appraisal of the devices will be explored based on
- Simplicity of handling
- Pushability
- Trackability
- Crossability
- Profile Physician appraisal of the Luminor 14m and Luminor 18 Drug Coated Balloon Dilatation Catheters and the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Dilatation Catheters will be explored based on
- Deflation time 2. Balloon Compliance 3. Visibility 4. Balloon refolding Physician appraisal for the Angiolite BTK Sirolimus Eluting Peripheral Stent System will be explored based on
- Recoil
- Radial force
- Ease to canalize the lesion
- Stent coverage
- Stent graft recrossing
- Balloon refusal And physician appraisal for the Sergeant Peripheral Support Catheter will be explored based on
- Trackability over the guide wire 2. Absence of kinking behaviour 3. Injection Capacity 4. Ease of changing guide wires 5. Ease to canalize the lesion
Measured: During procedure
Freedom from SAE
Freedom from SAE post-procedure and after 30 days, 1 year and 2 years (depending on the device that was used)
Measured: 2 years
Freedom from SADE
Freedom from SADE post-procedure and after 30 days, 1 year and 2 years (depending on the device that was used)
Measured: 2 years
Freedom from TLR
Freedom from Target Lesion Revascularization post-procedure and after 30 days, 1 year and 2 years (depending on the device that was used), defined as freedom from a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start30 May 2022
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease Below The KneeStudies 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
- 143 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- iVascular S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FCRE (Foundation for Cardiovascular Research and Education)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267548
- Sponsor's protocol ID
- FCRE-211206
- Acronym
- POP-BTK
- Status last verified
- Feb 2023
- First submitted
- 24 Feb 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. 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 14pro, Oceanus 18 and Oceanus 35 Balloon Catheters, the Luminor 14m and Luminor 18 Drug Coated Balloons, the Angiolite BTK Sirolimus Eluting Peripheral Stent System and the Sergeant Peripheral Support Catheter for the Endovascular Intervention in Popliteal and Infrapopliteal Arteries
- ClinicalTrials.gov ID
- NCT05267548
- Acronym / sponsor ID
- POP-BTK / FCRE-211206
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- iVascular S.L.U.Industry (pharma, biotech, devices)
- Collaborators
- FCRE (Foundation for Cardiovascular Research and Education)
- Study start
- 30 May 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 4 Mar 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 rationale of this study is to confirm and support the clinical safety and performance of the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Catheters, the Luminor 14m and Luminor 18 Drug Coated Balloons, the Angiolite BTK Sirolimus Eluting Peripheral Stent System and the Sergeant Peripheral Support Catheter in a real-word population of 143 patients who underwent an endovascular intervention the popliteal and/or infrapopliteal arteries within standard-of-care (SOC) where at least 1 of the investigational products from iVascular were used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this PMCF minimally invasive medical devices with special dedication towards the interventional cardiovascular field will be used. Indications for which the investigational devices are intended are listed in the protocol. Patients will be selected based on the investigator's assessment and evaluation of the underlying disease. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required assessment or from completing the study. Patients should be geographically stable, willing and able to cooperate in this clinical study, and remain available follow-up.
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 enrolment in the study.
- Target lesion(s) is/are located in the popliteal or infrapopliteal arteries
- Patient is eligible for treatment with the Oceanus 14pro Balloon Catheter and/or the Oceanus 18 Balloon Catheter and/or the Oceanus 35 Balloon Catheter and/or the Luminor 14m DCB and/or the Luminor 18 DCB and/or the Angiolite BTK Sirolimus Eluting Peripheral Stent System and/or the Sergeant Peripheral Support Catheter as described in the 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.
Primary outcome
Primary Safety Endpoint: Freedom from SAE/SADE
Time frame: 2 years
Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) during the procedure and up to 2 years after the procedure (depending on the device that was used).
Primary Efficacy Endpoint: Technical success
Time frame: During procedure
Technical success rate defined as successful crossing, introduction and deployment of the Oceanus 14pro Balloon Catheter and/or the Oceanus 18 Balloon Catheter and/or the Oceanus 35 Balloon Catheter and/or the Luminor 14m DCB and/or the Luminor 18 DCB and/or the Angiolite BTK Sirolimus Eluting Peripheral Stent System and/or the Sergeant Peripheral Support Catheter according to the respective IFU and without device related deficiencies.
4 secondary outcomes
Physician Appraisal
Time frame: During procedure
Freedom from SAE
Time frame: 2 years
Freedom from SADE
Time frame: 2 years
Freedom from TLR
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Peripheral Arterial Disease Below The Knee
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Active, not recruiting
A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease Below the Knee (STAND)
Peripheral Arterial Disease
Active, not recruiting
A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee
Peripheral Arterial Disease
Not yet recruiting
IVUS Guidance in BTK Interventions
Chronic Limb-Threatening Ischemia
Active, not recruitingObservational study
An All-Comers Observational Study of the MicroStent™ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
Peripheral Arterial Disease, Critical Lower Limb Ischemia
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.
Mieke Ramsdonck contact
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease Below The Knee, run by iVascular S.L.U. at 8 sites in Belgium.
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: status not confirmed, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mieke Ramsdonck (mieke.ramsdonck@FCRE.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint: Freedom from SAE/SADE (time frame: 2 years). 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 3 Feb 2023.