Peripheral Artery DiseaseNCT04907240
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
An observational study of Peripheral Artery Disease and Popliteal Aneurysm, run by W.L.Gore & Associates at 26 sites in 9 countries.
Trial summary
Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease, Popliteal Aneurysm, Hemodialysis Access
- What is being tested?
- GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Type of treatment
- Medical device
- How many people
- 614 participants
- Where
- 26 sitesin 9 countries
- Study dates
- 9 Oct 2021to Oct 2035
- How long will I take part?
- 10 Years
- 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: All consecutive patients presenting with an indication for endovascular repair of one of the eight indications (iliac, SFA, SFA ISR, VAA, PAA, Trauma/Injury, AV access and others) are eligible for screening for participation in the registry. Only patients who meet all inclusion and no exclusion criteria, and who consent to participate will be enrolled.
Who may be able to join
- Age ≥ 18 years
- Signed informed consent form
- Suitable for endovascular treatment with VSX based on treating physician's best medical judgment
- Willingness of the patient to adhere to institutional standard of care follow-up requirements
Who cannot join
- Non-compliant lesions where full expansion of an angioplasty balloon catheter is not achievable during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.
- Use of the VSX Device in lesions involving a major side branch that may be covered by the endoprosthesis.
- Lesion(s) cannot be treated with available VSX Device sizes per current Instructions for Use (IFU).
- Lesion requires treatment with an altered endoprosthesis or delivery system. (Do not cut the endoprosthesis. The endoprosthesis should only be placed and deployed using the supplied catheter system).
- Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or patient requires enrollment into more than one cohort) (Note: Only the first VSX treatment will be enrolled if concurrent VSX procedures are performed that would require enrollment into more than one cohort).
- Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
Show all 12Show fewer
- Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
- Unable to tolerate antiplatelet therapy.
- Patient has a non-controllable allergy to contrast or the VSX Device components.
- Pregnant or breast-feeding female at time of informed consent signature.
- Life expectancy < 12 months due to comorbidities.
- Patient has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).
Trial locations and contacts
26 sites in 9 countries.
26 sites in 9 countries
France5 sites
Centre Hospitalier Unversitaire d'Angers
Angers, 49933
Centre Hospitalier Regional Universitaire de Brest
Brest, 29200
Hopital Edouard Herriot (HCL)
Lyon, 69002
Hospital Paris Saint-Joseph
Paris, 75014
Clinique RHENA
Strasbourg, 67000
Germany5 sites
Cardioangiologisches Centrum Bethanien
Frankfurt, 60389
Marien Krankenhaus
Hamburg, 22087
University of Heidelberg
Heidelberg, D-69120
Krankenhaus Reinbek St. Adolf-Stift
Reinbek, 21465
University Hospital Tuebingen
Tübingen, 72076
Italy5 sites
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, 60127
Fondazione Poliambulanza
Brescia, 25124
S.C. Chirurgia Vascolare dell'A.O.U. di Modena
Modena, 41124
Ospedale San Giovanni Molinette
Torino, 10126
Dipartimento di Scienze Chirurgiche e Morfologiche
Varese, 21100
United Kingdom3 sites
Southmead Hospital
Bristol, BS10 5NB
Greater Glasgow Health Board
Glasgow, G12 0XH
Queen Elizabeth Hospital
London, SE18 4QH
Netherlands2 sites
Rijnstate
Arnhem, 6800 TA
Medical Center Leeuwarden
Leeuwarden, 8934 AD
Spain2 sites
Hospital Universitari Germans Trias i Pujol
Barcelona, 08916
Alvaro Cunqueiro Hospital
Vigo, 36213
Sweden2 sites
Skane University Hospital
Malmö, SE-205 02
Karolinska University Hospital
Solna, 171 64
About this study
Official title: Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface (VSX) Global Registry
Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Read the detailed description
This is an Observational, prospective, single-arm, multicenter, post-market registry to collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) for one of the following indications: Iliac, Superficial Femoral Artery (SFA), Superficial Femoral Artery In-stent restenosis (SFA ISR), Hemodialysis access (AV access), Visceral artery aneurysms (VAA), Trauma/Injury, Popliteal Artery Aneurysms (PAA), or Other. Approximately 35 sites in Europe will participate and a minimum of 614 patients will be enrolled in this registry. All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) will be included and followed through one year for Trauma/Injury and other; three years for VAA; five years for Iliac, SFA, SFA ISR and AV access and ten years for PAA per institutional standard of care.
- Conditions
- Peripheral Artery Disease, Popliteal Aneurysm, Hemodialysis Access, Visceral Artery Aneurysms, Trauma Injury
- Being tested
- GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Keywords
- Viabahn, EVAR, Propaten, Iliac, SFA, SFA ISR, AV access, VAA, PAA, Trauma, Injury
- Medical subject headings
- Peripheral Arterial Disease, Popliteal Artery Aneurysm, Accidental Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)Device
Intent to treat with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) in the treatment of Peripheral Artery Disease as part of routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Iliac | Subjects with de novo or restenotic lesions in the iliac arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) Receives: Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) | |
| Superficial Femoral Artery (SFA) | Subjects with de novo or restenotic lesions in the SFA and proximal popliteal arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) Receives: Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) | |
| Superficial Femoral Artery (SFA) In-Stent Restenosis (ISR) | Subjects with in-stent restenosis lesions in the SFA and proximal popliteal arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) Receives: Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) | |
| AV access | Subjects with stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access graft and in the venous outflow of dialysis access circuits, including the central veins treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) Receives: Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) | |
| Popliteal Artery Aneurysms | Subjects with popliteal artery aneurysms treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) Receives: Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) | |
| Trauma/Injury | Subjects with traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries) treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) Receives: Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) | |
| Visceral Artery Aneurysms | Subjects with isolated visceral artery aneurysms treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) Receives: Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) | |
| Others | Subjects treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) but do not fit any of the cohorts listed above. Receives: Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Device-Related Serious Adverse Events (SAE)
No adverse event that is deemed to be device-related and serious assessed by the investigator by cohort
Measured: 12 month
Secondary outcomes (14)
Freedom from Device-Related Serious Adverse Events (SAE) for patients treated specifically with PAHR09-13
Equivalent device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface devices with catalogue numbers PAHR09-13.
No adverse event that is deemed to be device-related and serious assessed by the investigator by cohort
Measured: 36 months
Freedom from Target Lesion Revascularization (TLR) for patients treated specifically with PAHR09-13
Equivalent device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface devices with catalogue numbers PAHR09-13.
No surgical or percutaneous revascularization procedure of the original treated lesion
Measured: 36 months
Primary patency for subjects treated in iliac
Blood flow through the target lesion without the need for repeat surgical or endovascular procedures
Measured: 60 months
Freedom from major amputation for subjects treated in iliac
No amputation above the level of the ankle of the treated index limb
Measured: 60 months
Freedom from Target Lesion Revascularization (TLR) for subjects treated in SFA de novo / restenotic and SFA ISR
No surgical or percutaneous revascularization procedure of the original treated lesion
Measured: 60 months
Freedom from major amputations for subjects treated in SFA de novo / restenotic and SFA ISR
No amputation above the level of the ankle of the treated index limb
Measured: 60 months
Access secondary patency for subjects treated in Hemodialysis Access
Blood flow through the original treated lesion with the use of an additional or secondary surgical or endovascular procedures after occlusion occurs, with freedom from device related abandonment.
Secondary access patency is maintained if the patient can still dialyze through the access but has abandoned it for some other reason such as a transplant
Measured: 60 months
Freedom from death of any cause for subjects treated in Hemodialysis Access
Patient is free from death of any cause (is alive)
Measured: 60 months
Primary Patency for subjects treated in PAA
Blood flow through the target lesion without the need for repeat surgical or endovascular procedures
Measured: 120 months
Limb Salvage for subjects treated in PAA
Absence of an amputation above the level of the ankle of the index limb
Measured: 120 months
Primary Patency for subjects treated in VAA
Blood flow through the target lesion without the need for repeat surgical or endovascular procedures
Measured: 36 months
Device-related thrombosis for subjects treated in VAA
Stent thrombosis deemed to be device-related as assessed by the Investigator.
Measured: 36 months
Treated Lesion Primary patency for subjects treated in Trauma-Injury
Blood flow through the target lesion without the need for repeat surgical or endovascular procedures
Measured: 12 months
Device-related thrombosis for subjects treated in Trauma-Injury
Stent thrombosis deemed to be device-related as assessed by the Investigator.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start9 Oct 2021
- Primary completionOct 2026 (estimated)
- Study completionOct 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- 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
- 614 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel Reijnen, MD, PhD, Principal investigator, Rijnstate Hospital, Arnhem, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907240
- Sponsor's protocol ID
- VSX 20-03
- Status last verified
- Aug 2026
- First submitted
- 25 May 2021
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Reijnen MMPJ, Mezes P, Tigkiropoulos K. One-Year Clinical Outcomes of a Self-Expanding Covered Stent for Aortoiliac Occlusive Disease. J Endovasc Ther. 2025 Dec 26:15266028251399582. doi: 10.1177/15266028251399582. Online ahead of print.
PubMed 41451903
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface (VSX) Global Registry
- ClinicalTrials.gov ID
- NCT04907240
- Acronym / sponsor ID
- VSX 20-03
- Conditions
- Peripheral Artery Disease, Popliteal Aneurysm, Hemodialysis Access, Visceral Artery Aneurysms, Trauma Injury
- Keywords
- Viabahn, EVAR, Propaten, Iliac, SFA, SFA ISR, AV access, VAA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 614 participants (estimated)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2035 (estimated)
- First posted
- 28 May 2021 (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.
Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Detailed description
This is an Observational, prospective, single-arm, multicenter, post-market registry to collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) for one of the following indications: Iliac, Superficial Femoral Artery (SFA), Superficial Femoral Artery In-stent restenosis (SFA ISR), Hemodialysis access (AV access), Visceral artery aneurysms (VAA), Trauma/Injury, Popliteal Artery Aneurysms (PAA), or Other. Approximately 35 sites in Europe will participate and a minimum of 614 patients will be enrolled in this registry. All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) will be included and followed through one year for Trauma/Injury and other; three years for VAA; five years for Iliac, SFA, SFA ISR and AV access and ten years for PAA per institutional standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Iliac | – | Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)Subjects with de novo or restenotic lesions in the iliac arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) |
| Superficial Femoral Artery (SFA) | – | Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)Subjects with de novo or restenotic lesions in the SFA and proximal popliteal arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) |
| Superficial Femoral Artery (SFA) In-Stent Restenosis (ISR) | – | Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)Subjects with in-stent restenosis lesions in the SFA and proximal popliteal arteries treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) |
| AV access | – | Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)Subjects with stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access graft and in the venous outflow of dialysis access circuits, including the central veins treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) |
| Popliteal Artery Aneurysms | – | Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)Subjects with popliteal artery aneurysms treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) |
| Trauma/Injury | – | Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)Subjects with traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries) treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) |
| Visceral Artery Aneurysms | – | Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)Subjects with isolated visceral artery aneurysms treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) |
| Others | – | Device: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)Subjects treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) but do not fit any of the cohorts listed above. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients presenting with an indication for endovascular repair of one of the eight indications (iliac, SFA, SFA ISR, VAA, PAA, Trauma/Injury, AV access and others) are eligible for screening for participation in the registry. Only patients who meet all inclusion and no exclusion criteria, and who consent to participate will be enrolled.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Signed informed consent form
- Suitable for endovascular treatment with VSX based on treating physician's best medical judgment
- Willingness of the patient to adhere to institutional standard of care follow-up requirements
Key exclusion criteria (12 listed)
- Non-compliant lesions where full expansion of an angioplasty balloon catheter is not achievable during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.
- Use of the VSX Device in lesions involving a major side branch that may be covered by the endoprosthesis.
- Lesion(s) cannot be treated with available VSX Device sizes per current Instructions for Use (IFU).
- Lesion requires treatment with an altered endoprosthesis or delivery system. (Do not cut the endoprosthesis. The endoprosthesis should only be placed and deployed using the supplied catheter system).
- Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or patient requires enrollment into more than one cohort) (Note: Only the first VSX treatment will be enrolled if concurrent VSX procedures are performed that would require enrollment into more than one cohort).
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 |
|---|---|---|
| GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)Intent to treat with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) in the treatment of Peripheral Artery Disease as part of routine clinical practice. | Device | AV access, Iliac, Others, Popliteal Artery Aneurysms, Superficial Femoral Artery (SFA), Superficial Femoral Artery (SFA) In-Stent Restenosis (ISR), Trauma/Injury, Visceral Artery Aneurysms |
Primary outcome
Freedom from Device-Related Serious Adverse Events (SAE)
Time frame: 12 month
No adverse event that is deemed to be device-related and serious assessed by the investigator by cohort
14 secondary outcomes
Freedom from Device-Related Serious Adverse Events (SAE) for patients treated specifically with PAHR09-13
Time frame: 36 months
Freedom from Target Lesion Revascularization (TLR) for patients treated specifically with PAHR09-13
Time frame: 36 months
Primary patency for subjects treated in iliac
Time frame: 60 months
Freedom from major amputation for subjects treated in iliac
Time frame: 60 months
Freedom from Target Lesion Revascularization (TLR) for subjects treated in SFA de novo / restenotic and SFA ISR
Time frame: 60 months
Freedom from major amputations for subjects treated in SFA de novo / restenotic and SFA ISR
Time frame: 60 months
Access secondary patency for subjects treated in Hemodialysis Access
Time frame: 60 months
Freedom from death of any cause for subjects treated in Hemodialysis Access
Time frame: 60 months
Primary Patency for subjects treated in PAA
Time frame: 120 months
Limb Salvage for subjects treated in PAA
Time frame: 120 months
Primary Patency for subjects treated in VAA
Time frame: 36 months
Device-related thrombosis for subjects treated in VAA
Time frame: 36 months
Treated Lesion Primary patency for subjects treated in Trauma-Injury
Time frame: 12 months
Device-related thrombosis for subjects treated in Trauma-Injury
Time frame: 12 months
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 20 Aug 2026.
- Results publication: PubMed 41451903Reijnen MMPJ, Mezes P, Tigkiropoulos K. One-Year Clinical Outcomes of a Self-Expanding Covered Stent for Aortoiliac Occlusive Disease. J Endovasc Ther. 2025 Dec 26:15266028251399582. doi: 10.1177/15266028251399582. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Michel Reijnen, MD, PhD principal investigator
Rijnstate Hospital, Arnhem, The Netherlands
26 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease and Popliteal Aneurysm, run by W.L.Gore & Associates at 26 sites in 9 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 4 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France, Germany, Italy, United Kingdom, Netherlands and 4 more countries. 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?
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?
Freedom from Device-Related Serious Adverse Events (SAE) (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04907240, which also lists 1 linked publication.
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 20 Aug 2026.