Coronary Artery DiseaseNCT05543096
PMCF Study for Cardiology Access Procedures
An observational study of Coronary Artery Disease, run by Cordis US Corp. at 8 sites in 2 countries.
Trial summary
This Post-market clinical follow-up (PMCF) study is designed as retrospective, multi-center study to collect real-life data. A multi-center design is used to ensure a representative sample of the physicians who have performed the procedure and to provide a reasonable enrolment period for the required data to be… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Adroit Guiding Catheter, Cordis Transradial Access Devices, Cordis Diagnostic Catheters, Cordis Guidewires
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 23 May 2022to 7 Sep 2022
- 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: Diseased patients with CAD who underwent a PCI within standard-of-care (SOC) of the coronary arterial vessel. In this PMCF minimally invasive medical devices will be used. Indications for which the study devices are intended are listed in section 3.1. Patients will be selected based on the investigator's assessment and evaluation of the underlying disease retrospective. The patient's medical condition should have been stable, with no underlying medical condition which would prevent them from undergoing the required endovascular intervention at the time of procedure. The total sample size for this PMCF study is 200 patients, divided over up to 20 sites, throughout an enrolment period of 6 months.
Who may be able to join
- Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for percutaneous coronary intervention (PCI).
- Patient is >18 years old at the conduction of the procedure.
- Patient is eligible for treatment with Adroit Guiding Catheter Cordis Transradial Access Devices
- RAIN Sheath
- Avanti Plus Transradial Kit Cordis Diagnostic Cathheters
- Super Torque
Show all 17Show fewer
- Super Torque MB
- Super Torque Plus
- Infiniti 4F
- Infiniti 5F/6F
- Tempo 4F
- Tempo Aqua
- High Flow
- Pigtail Straightener Cordis Guidewires
- ATW
- Stabilizer
- Wizdom as described in the IFU for each device.
Who cannot join
- Anatomy or size of vessels that did not allow appropriate usage of the study devices, following IFU of the study devices.
- Known contraindication and/or allergy to (a component of) an study device as described in the IFU of the devices.
- Women who were pregnant or lactating at the time of the procedure.
- Any patient who was hemodynamically unstable at onset of procedure.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Austria6 sites
Kepler Universitätsklinikum GmbH
Linz
Ordensklinikum Linz GmbH
Linz
ST. Poelten
Sankt Pölten
Klinik Favoriten
Vienna
Klinik Floridsdorf
Vienna
Klinikum Wels Grieskirchen
Wels
About this study
Official title: A Retrospective PMCF Study Evaluating the Safety and Clinical Performance of the Adroit Guiding Catheter, the Cordis Transradial Access Devices (RAIN Sheath and Avanti Plus Transradial Kit), the Cordis Diagnostic Catheters (Super Torque, Super Torque MB, Super Torque Plus, Infiniti 4F, Infiniti 5F/6F, Tempo 4F, Tempo Aqua, High Flow and Pigtail Straightener) and the Cordis Guidewires (ATW, Stabilizer and Wizdom) for Percutaneous Coronary Interventions.
This Post-market clinical follow-up (PMCF) study is designed as retrospective, multi-center study to collect real-life data.
A multi-center design is used to ensure a representative sample of the physicians who have performed the procedure and to provide a reasonable enrolment period for the required data to be collected.
The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-word population of 200 patients who underwent an endovascular intervention within standard-of-care (SOC) where at least 1 of the products (named above) from Cordis US Corp were used.
Read the detailed description
Treatment of coronary artery disease (CAD) is dependent on percutaneous coronary intervention (PCI). PCI includes a group of minimally invasive (non-surgical) procedures to treat narrowing of the coronary arteries and therefore restore arterial blood flow. PCI techniques have significantly improved over time1 and requires cardiac catherterization and an experienced physician. In the field of catheters, there are a variety of options from Diagnostic Catheters, Guiding Catheters, Guidewires or even Transradial Acces Devices1-5.
All devices have different advantages and disadvantages and an appropriate selection is a requirement for successful angioplasty of coronary artery lesions2,3. Which device to choose depends on the anatomy of the vessel, the type of lesion and the technique used for the treatment. The different Catheters and Access Devices (Diagnostic Catheters, Guiding Catheters, Guidewires and Transradial Acces Devices) have proven their functionality and safety over the years and have become widely accepted supportive devices for the treatment of coronary atery disease. For example, the technical sucess for Diagnostic Catheters is high with about 95% technical success and about 100% procedural succes6-17.
In this regard, the purpose of the current post market surveillance trial is to assess the safety and efficacy of different devices from Cordis (Adroit Guiding Catheter, Cordis Transradial Access Devices, Cordis Diagnostic Cathheters, and Cordis Guidewires). The devices under investigation in the current study are the Adroit Guiding Catheter, Cordis Transradial Access Devices (RAIN Sheath and Avanti Plus Transradial Kit), Cordis Diagnostic Cathheters (Super Torque, Super Torque MB, Super Torque Plus, Infiniti 4F, Infiniti 5F/6F, Tempo 4F, Tempo Aqua, High Flow and Pigtail Straightener), Cordis Guidewires (ATW, Stabilizer, Wizdom), which are described in detail in section 3.1.
- Conditions
- Coronary Artery Disease
- Being tested
- Adroit Guiding Catheter, Cordis Transradial Access Devices, Cordis Diagnostic Catheters, Cordis Guidewires
- Keywords
- Cardiology
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adroit Guiding Catheter, Cordis Transradial Access Devices, Cordis Diagnostic Catheters, Cordis GuidewiresDevice
Observation
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint: Freedom from Serious Adverse Events and Serious Adverse Device Effects
Freedom from SAEs and SADEs during the procedure and up to 30 days after the procedure
Measured: 30 days after procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Adroit Guiding Catheter according to the IFU and without device related deficiencies
Measured: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Transradial Access Device RAIN Sheath according to the IFU and without device related deficiencies
Measured: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Transradial Access Device Avanti Plus Transradial Kit according to the IFU and without device related deficiencies
Measured: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Super Torque according to the IFU and without device related deficiencies
Measured: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Super Torque MB according to the IFU and without device related deficiencies
Measured: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Super Torque Plus according to the IFU and without device related deficiencies
Measured: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Infiniti 4F according to the IFU and without device related deficiencies
Measured: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Infiniti 5F/6F according to the IFU and without device related deficiencies
Measured: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Tempo 4F according to the IFU and without device related deficiencies
Measured: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Tempo Aqua according to the IFU and without device related deficiencies
Measured: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter High FLow according to the IFU and without device related deficiencies
Measured: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Pigtail Straightener according to the IFU and without device related deficiencies
Measured: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Guidewire ATW according to the IFU and without device related deficiencies
Measured: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Guidewire Stabilizer according to the IFU and without device related deficiencies
Measured: 30 days post procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Guidewire Wizdom according to the IFU and without device related deficiencies
Measured: 30 days post procedure
Secondary outcomes (9)
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Vista Brite Tip Guiding Catheter according to the respective IFU and without device related deficiencies
Measured: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis vascular access device RAILWAY Shealthless Access System according to the respective IFU and without device related deficiencies
Measured: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis vascular access device Avanti+ according to the respective IFU and without device related deficiencies
Measured: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis vascular access device Brite - Tip according to the respective IFU and without device related deficiencies
Measured: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis vascular access device Vista Brite IG according to the respective IFU and without device related deficiencies
Measured: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis vascular access device Vessel Dilator according to the respective IFU and without device related deficiencies
Measured: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis vascular closure device MynxGrip according to the respective IFU and without device related deficiencies
Measured: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis vascular closure device Mynx Control according to the respective IFU and without device related deficiencies
Measured: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Technical success rate defined as successful crossing, introduction and deployment of Cordis Guidewire Emerald according to the respective IFU and without device related deficiencies.
Measured: 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start23 May 2022
- Primary completion31 Aug 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FCRE (Foundation for Cardiovascular Research and Education)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543096
- Sponsor's protocol ID
- FCRE-220111_Cardio
- Status last verified
- Jul 2023
- First submitted
- 29 Jun 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective PMCF Study Evaluating the Safety and Clinical Performance of the Adroit Guiding Catheter, the Cordis Transradial Access Devices (RAIN Sheath and Avanti Plus Transradial Kit), the Cordis Diagnostic Catheters (Super Torque, Super Torque MB, Super Torque Plus, Infiniti 4F, Infiniti 5F/6F, Tempo 4F, Tempo Aqua, High Flow and Pigtail Straightener) and the Cordis Guidewires (ATW, Stabilizer and Wizdom) for Percutaneous Coronary Interventions.
- ClinicalTrials.gov ID
- NCT05543096
- Acronym / sponsor ID
- FCRE-220111_Cardio
- Conditions
- Coronary Artery Disease
- Keywords
- Cardiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Collaborators
- FCRE (Foundation for Cardiovascular Research and Education)
- Study start
- 23 May 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 16 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.
This Post-market clinical follow-up (PMCF) study is designed as retrospective, multi-center study to collect real-life data.
A multi-center design is used to ensure a representative sample of the physicians who have performed the procedure and to provide a reasonable enrolment period for the required data to be collected.
The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-word population of 200 patients who underwent an endovascular intervention within standard-of-care (SOC) where at least 1 of the products (named above) from Cordis US Corp were used.
Detailed description
Treatment of coronary artery disease (CAD) is dependent on percutaneous coronary intervention (PCI). PCI includes a group of minimally invasive (non-surgical) procedures to treat narrowing of the coronary arteries and therefore restore arterial blood flow. PCI techniques have significantly improved over time1 and requires cardiac catherterization and an experienced physician. In the field of catheters, there are a variety of options from Diagnostic Catheters, Guiding Catheters, Guidewires or even Transradial Acces Devices1-5.
All devices have different advantages and disadvantages and an appropriate selection is a requirement for successful angioplasty of coronary artery lesions2,3. Which device to choose depends on the anatomy of the vessel, the type of lesion and the technique used for the treatment. The different Catheters and Access Devices (Diagnostic Catheters, Guiding Catheters, Guidewires and Transradial Acces Devices) have proven their functionality and safety over the years and have become widely accepted supportive devices for the treatment of coronary atery disease. For example, the technical sucess for Diagnostic Catheters is high with about 95% technical success and about 100% procedural succes6-17.
In this regard, the purpose of the current post market surveillance trial is to assess the safety and efficacy of different devices from Cordis (Adroit Guiding Catheter, Cordis Transradial Access Devices, Cordis Diagnostic Cathheters, and Cordis Guidewires). The devices under investigation in the current study are the Adroit Guiding Catheter, Cordis Transradial Access Devices (RAIN Sheath and Avanti Plus Transradial Kit), Cordis Diagnostic Cathheters (Super Torque, Super Torque MB, Super Torque Plus, Infiniti 4F, Infiniti 5F/6F, Tempo 4F, Tempo Aqua, High Flow and Pigtail Straightener), Cordis Guidewires (ATW, Stabilizer, Wizdom), which are described in detail in section 3.1.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diseased patients with CAD who underwent a PCI within standard-of-care (SOC) of the coronary arterial vessel. In this PMCF minimally invasive medical devices will be used. Indications for which the study devices are intended are listed in section 3.1. Patients will be selected based on the investigator's assessment and evaluation of the underlying disease retrospective. The patient's medical condition should have been stable, with no underlying medical condition which would prevent them from undergoing the required endovascular intervention at the time of procedure. The total sample size for this PMCF study is 200 patients, divided over up to 20 sites, throughout an enrolment period of 6 months.
Key inclusion criteria (17 listed)
- Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for percutaneous coronary intervention (PCI).
- Patient is >18 years old at the conduction of the procedure.
- Patient is eligible for treatment with Adroit Guiding Catheter Cordis Transradial Access Devices
Key exclusion criteria (4 listed)
- Anatomy or size of vessels that did not allow appropriate usage of the study devices, following IFU of the study devices.
- Known contraindication and/or allergy to (a component of) an study device as described in the IFU of the devices.
- Women who were pregnant or lactating at the time of the procedure.
- Any patient who was hemodynamically unstable at onset of 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 |
|---|---|---|
| Adroit Guiding Catheter, Cordis Transradial Access Devices, Cordis Diagnostic Catheters, Cordis GuidewiresObservation | Device | – |
Primary outcome
Primary Safety Endpoint: Freedom from Serious Adverse Events and Serious Adverse Device Effects
Time frame: 30 days after procedure
Freedom from SAEs and SADEs during the procedure and up to 30 days after the procedure
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Time frame: 30 days post procedure
Technical success rate defined as successful crossing, instroduction and deployment of Adroit Guiding Catheter according to the IFU and without device related deficiencies
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Time frame: 30 days post procedure
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Transradial Access Device RAIN Sheath according to the IFU and without device related deficiencies
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Time frame: 30 days post procedure
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Transradial Access Device Avanti Plus Transradial Kit according to the IFU and without device related deficiencies
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Time frame: 30 days post procedure
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Super Torque according to the IFU and without device related deficiencies
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Time frame: 30 days post procedure
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Super Torque MB according to the IFU and without device related deficiencies
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Time frame: 30 days post procedure
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Super Torque Plus according to the IFU and without device related deficiencies
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Time frame: 30 days post procedure
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Infiniti 4F according to the IFU and without device related deficiencies
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Time frame: 30 days post procedure
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Infiniti 5F/6F according to the IFU and without device related deficiencies
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Time frame: 30 days post procedure
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Tempo 4F according to the IFU and without device related deficiencies
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Time frame: 30 days post procedure
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Tempo Aqua according to the IFU and without device related deficiencies
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Time frame: 30 days post procedure
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter High FLow according to the IFU and without device related deficiencies
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Time frame: 30 days post procedure
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Diagnostic Cathheter Pigtail Straightener according to the IFU and without device related deficiencies
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Time frame: 30 days post procedure
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Guidewire ATW according to the IFU and without device related deficiencies
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Time frame: 30 days post procedure
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Guidewire Stabilizer according to the IFU and without device related deficiencies
Primary Efficacy Endpoint: Successful crossing, instroduction and deployment
Time frame: 30 days post procedure
Technical success rate defined as successful crossing, instroduction and deployment of Cordis Guidewire Wizdom according to the IFU and without device related deficiencies
9 secondary outcomes
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Time frame: 30 days post procedure
Secondary Efficacy Endpoint: Successful crossing, introduction and deployment
Time frame: 30 days post 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 28 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Cordis US Corp. at 8 sites in 2 countries.
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 17 inclusion and 4 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 28 Jul 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 Austria, 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?
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?
Primary Safety Endpoint: Freedom from Serious Adverse Events and Serious Adverse Device Effects (time frame: 30 days after procedure). The study lists 16 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 28 Jul 2023.