Cerebral AneurysmpSPAIN_HPCNCT06201598
Prospective, Single-Arm, Multicenter Study to Evaluate the Effectiveness and Safety of Endovascular Treatment in Patients With Cerebral Aneurysms Using P64 and P48 Flow-Diverter Stents
An observational study of Cerebral Aneurysm and Thromboembolic Disease, run by Hospital Universitario Central de Asturias at 11 sites in Spain.
Trial summary
The use of flow-diverting stents for the endovascular treatment of cerebral aneurysms has proven to be effective and efficient in several clinical studies, leading to its widespread adoption. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Aneurysm, Thromboembolic Disease
- What is being tested?
- Group 1 - Intervention 1
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 11 sitesSpain
- Study dates
- 12 Jan 2024to 15 Dec 2025
- 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: The study will include all patients with intracranial aneurysms or dissections suitable for endovascular treatment with a flow-diverting device, who attend the participating hospitals.
Who may be able to join
- Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebral aneurysms.
- Signed informed consent by the patient or their representative.
Who cannot join
- Patients under 18 years of age.
- Absence of signed informed consent by the patient or their representative.
- Known, medically untreatable allergy to iodinated contrast.
- Pregnant women or those breastfeeding.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Spain11 sites, 11 recruiting
- Recruiting
Hospital Universitario de A Coruña
A Coruña, 15006
- Recruiting
Hospital Universitari Germans Trias I Pujol
Badalona, 08916
- Recruiting
Hospital Universitari Vall D Hebron
Barcelona, 08035
- Recruiting
Hospital Universitario de Burgos
Burgos, 09006
- Recruiting
Hospital Universitario de Donostia
Donostia / San Sebastian, 20014
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Regional Universitario de Malaga
Málaga, 29010
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, 33006
- Recruiting
Hospital Parc Tauli
Sabadell, 08208
- Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
The use of flow-diverting stents for the endovascular treatment of cerebral aneurysms has proven to be effective and efficient in several clinical studies, leading to its widespread adoption. Devices with a higher number of filaments have a greater flow-diverting effect and less variation when there are changes in the caliber of the underlying vessel or in curved vessels. However, ischemic complications secondary to their implantation have been reported, prompting the development of various strategies to reduce their thrombogenicity. Phenox is the only company to date that has developed an anti-thrombogenic coating, known as HPC (Hydrophilic Polymer Coating), which, when applied to the p64 MW HPC and p48 MW HPC devices, has shown to reduce the likelihood of thromboembolic complications associated with their implantation.
Read the detailed description
The goal of this study is to evaluate the effectiveness and safety of endovascular treatment for cerebral aneurysms using the flow-diverting stents p64MW (flow modulation device) HPC and p48MW HPC in the routine clinical practice of several Spanish hospitals. It is therefore an observational study, carried out with devices already commercialized. The success rate of the intervention, the rate of hemorrhagic and thromboembolic complications, as well as variables related to the clinical and radiological follow-up of patients over a 12-month period, will be analyzed.
- Conditions
- Cerebral Aneurysm, Thromboembolic Disease
- Being tested
- Group 1 - Intervention 1
- Keywords
- Cerebral aneurysm, Flow-diverting stents, Thrombogenicity, p64 MW HPC, p48 MW HPC
- Medical subject headings
- Intracranial Aneurysm, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 - Intervention 1Device
Endovascular treatment of cerebral aneurysms through the implantation of p64MW HPC and p48MW HPC devices.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with p64MW HPC and p48MW HPC | Patients with intracranial aneurysms or dissections undergoing endovascular treatment with p64MW HPC and p48MW HPC flow-diverting devices. Receives: Device: Group 1 - Intervention 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness objective
Evaluation of the effectiveness of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.
Measured: 1 year
Safety Objective
Evaluation of the safety of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.
Measured: 1 year
Secondary outcomes (10)
Intervention success
Rate of the ability to position the stent in the indicated location.
Measured: During the procedure
Thromboembolic complications
Rate of cerebral thromboembolic complications during the intervention and during patient follow-up.
Measured: 1 year
Hemorrhagic complications
Rate of cerebral and systemic hemorrhagic complications during the intervention and during patient follow-up.
Measured: 1 year
Mortality
Mortality rate during patient follow-up.
Measured: 1 year
Clinical evolution of the patient using the National Institutes of Health Stroke Scale (NIHSS) and the Modified Rankin Scale (MRS).
NIHSS at 24 hours and at discharge (range 0-42, with higher scores indicating greater stroke severity).
MRS at 24 hours, at discharge, at 4-6 months and 12 months post-treatment (range 0-6, from no symptoms to dead, for the evaluation of neurological functional disability).
Measured: 1 year
Intimal hyperplasia
Rate of intimal hyperplasia within the stent leading to a luminal stenosis of over 50%, assessed through digital angiography at 4-6 months and 12 months post-treatment.
Measured: 1 year
Thromboembolic complications with a single antiplatelet drug
Rate of thromboembolic complications during the intervention and patient follow-up in cases where a single antiplatelet drug is administered.
Measured: 1 year
Intimal hyperplasia with a single antiplatelet drug
Rate of intimal hyperplasia within the stent leading to a luminal stenosis of over 50% in cases where a single antiplatelet drug is administered, assessed through digital angiography at 4-6 months and 12 months post-treatment.
Measured: 1 year
Visible ischemic complications
Rate of visible ischemic complications in MRI during patient follow-up (4-6 months).
Measured: 6 months
Aneurysm occlusion
Aneurysm occlusion rate assessed through digital angiography at 6 and 12 months post-intervention, according to the O'Kelly-Marotta (OKM) occlusion scale.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start12 Jan 2024
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Cerebral AneurysmStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Central de Asturias
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Vega Valdes, Hospital Universitario Central de Asturias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201598
- Sponsor's protocol ID
- 2023.014
- Acronym
- pSPAIN_HPC
- Status last verified
- Nov 2024
- First submitted
- 15 Dec 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kallmes DF, Ding YH, Dai D, Kadirvel R, Lewis DA, Cloft HJ. A new endoluminal, flow-disrupting device for treatment of saccular aneurysms. Stroke. 2007 Aug;38(8):2346-52. doi: 10.1161/STROKEAHA.106.479576. Epub 2007 Jul 5.
PubMed 17615366Kadirvel R, Ding YH, Dai D, Rezek I, Lewis DA, Kallmes DF. Cellular mechanisms of aneurysm occlusion after treatment with a flow diverter. Radiology. 2014 Feb;270(2):394-9. doi: 10.1148/radiol.13130796. Epub 2013 Oct 28.
PubMed 24086073Cancelliere NM, Nicholson P, Radovanovic I, Mendes KM, Orru E, Krings T, Pereira VM. Comparison of intra-aneurysmal flow modification using optical flow imaging to evaluate the performance of Evolve and Pipeline flow diverting stents. J Neurointerv Surg. 2020 Aug;12(8):814-817. doi: 10.1136/neurintsurg-2019-015696. Epub 2020 Apr 21.
PubMed 32317371Shapiro M, Raz E, Becske T, Nelson PK. Variable porosity of the pipeline embolization device in straight and curved vessels: a guide for optimal deployment strategy. AJNR Am J Neuroradiol. 2014 Apr;35(4):727-33. doi: 10.3174/ajnr.A3742. Epub 2013 Sep 26.
PubMed 24072622Briganti F, Leone G, Marseglia M, Cicala D, Caranci F, Maiuri F. p64 Flow Modulation Device in the treatment of intracranial aneurysms: initial experience and technical aspects. J Neurointerv Surg. 2016 Feb;8(2):173-80. doi: 10.1136/neurintsurg-2015-011743. Epub 2015 Apr 20.
PubMed 25895510Fischer S, Aguilar-Perez M, Henkes E, Kurre W, Ganslandt O, Bazner H, Henkes H. Initial Experience with p64: A Novel Mechanically Detachable Flow Diverter for the Treatment of Intracranial Saccular Sidewall Aneurysms. AJNR Am J Neuroradiol. 2015 Nov;36(11):2082-9. doi: 10.3174/ajnr.A4420. Epub 2015 Aug 13.
PubMed 26272970Morais R, Mine B, Bruyere PJ, Naeije G, Lubicz B. Endovascular treatment of intracranial aneurysms with the p64 flow diverter stent: mid-term results in 35 patients with 41 intracranial aneurysms. Neuroradiology. 2017 Mar;59(3):263-269. doi: 10.1007/s00234-017-1786-2. Epub 2017 Feb 24.
PubMed 28236050Briganti F, Leone G, Ugga L, Marseglia M, Macera A, Manto A, Delehaye L, Resta M, Resta M, Burdi N, Nuzzi NP, Divenuto I, Caranci F, Muto M, Solari D, Cappabianca P, Maiuri F. Mid-term and long-term follow-up of intracranial aneurysms treated by the p64 Flow Modulation Device: a multicenter experience. J Neurointerv Surg. 2017 Jan;9(1):70-76. doi: 10.1136/neurintsurg-2016-012502. Epub 2016 Jul 20.
PubMed 27439887Aguilar Perez M, Henkes E, Hellstern V, Serna Candel C, Wendl C, Bazner H, Ganslandt O, Henkes H. Endovascular Treatment of Anterior Circulation Aneurysms With the p64 Flow Modulation Device: Mid- and Long-Term Results in 617 Aneurysms From a Single Center. Oper Neurosurg. 2021 Mar 15;20(4):355-363. doi: 10.1093/ons/opaa425.
PubMed 33469666De Beule T, Boulanger T, Heye S, van Rooij WJ, van Zwam WH, Stockx L. p64 flow diverter: Results in 108 patients from a single center. Interv Neuroradiol. 2021 Feb;27(1):51-59. doi: 10.1177/1591019920932048. Epub 2020 Jun 6.
PubMed 32506988Aguilar Perez M, Bhogal P, Henkes E, Ganslandt O, Bazner H, Henkes H. In-stent Stenosis after p64 Flow Diverter Treatment. Clin Neuroradiol. 2018 Dec;28(4):563-568. doi: 10.1007/s00062-017-0591-y. Epub 2017 May 9.
PubMed 28488025Sirakov S, Sirakov A, Bhogal P, Penkov M, Minkin K, Ninov K, Hristov H, Karakostov V, Raychev R. The p64 Flow Diverter-Mid-term and Long-term Results from a Single Center. Clin Neuroradiol. 2020 Sep;30(3):471-480. doi: 10.1007/s00062-019-00823-y. Epub 2019 Aug 9.
PubMed 31399749Bonafe A, Perez MA, Henkes H, Lylyk P, Bleise C, Gascou G, Sirakov S, Sirakov A, Stockx L, Turjman F, Petrov A, Roth C, Narata AP, Barreau X, Loehr C, Berlis A, Pierot L, Mis M, Goddard T, Clifton A, Klisch J, Walesa C, Dall'Olio M, Spelle L, Clarencon F, Yakovlev S, Keston P, Nuzzi NP, Dima S, Wendl C, Willems T, Schramm P. Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device. J Neurointerv Surg. 2022 Sep;14(9):898-903. doi: 10.1136/neurintsurg-2021-017809. Epub 2021 Nov 15.
PubMed 34782399Tonetti DA, Jankowitz BT, Gross BA. Antiplatelet Therapy in Flow Diversion. Neurosurgery. 2020 Jan 1;86(Suppl 1):S47-S52. doi: 10.1093/neuros/nyz391.
PubMed 31838537Lenz-Habijan T, Bhogal P, Peters M, Bufe A, Martinez Moreno R, Bannewitz C, Monstadt H, Henkes H. Hydrophilic Stent Coating Inhibits Platelet Adhesion on Stent Surfaces: Initial Results In Vitro. Cardiovasc Intervent Radiol. 2018 Nov;41(11):1779-1785. doi: 10.1007/s00270-018-2036-7. Epub 2018 Jul 23.
PubMed 30039502
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-Arm, Multicenter Study to Evaluate the Effectiveness and Safety of Endovascular Treatment in Patients With Cerebral Aneurysms Using P64 and P48 Flow-Diverter Stents
- ClinicalTrials.gov ID
- NCT06201598
- Acronym / sponsor ID
- pSPAIN_HPC / 2023.014
- Conditions
- Cerebral Aneurysm, Thromboembolic Disease
- Keywords
- Cerebral aneurysm, Flow-diverting stents, Thrombogenicity, p64 MW HPC, p48 MW HPC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Universitario Central de AsturiasUniversity, hospital or other
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 11 Jan 2024 (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 use of flow-diverting stents for the endovascular treatment of cerebral aneurysms has proven to be effective and efficient in several clinical studies, leading to its widespread adoption. Devices with a higher number of filaments have a greater flow-diverting effect and less variation when there are changes in the caliber of the underlying vessel or in curved vessels. However, ischemic complications secondary to their implantation have been reported, prompting the development of various strategies to reduce their thrombogenicity. Phenox is the only company to date that has developed an anti-thrombogenic coating, known as HPC (Hydrophilic Polymer Coating), which, when applied to the p64 MW HPC and p48 MW HPC devices, has shown to reduce the likelihood of thromboembolic complications associated with their implantation.
Detailed description
The goal of this study is to evaluate the effectiveness and safety of endovascular treatment for cerebral aneurysms using the flow-diverting stents p64MW (flow modulation device) HPC and p48MW HPC in the routine clinical practice of several Spanish hospitals. It is therefore an observational study, carried out with devices already commercialized. The success rate of the intervention, the rate of hemorrhagic and thromboembolic complications, as well as variables related to the clinical and radiological follow-up of patients over a 12-month period, will be analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with p64MW HPC and p48MW HPC | – | Device: Group 1 - Intervention 1Patients with intracranial aneurysms or dissections undergoing endovascular treatment with p64MW HPC and p48MW HPC flow-diverting devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include all patients with intracranial aneurysms or dissections suitable for endovascular treatment with a flow-diverting device, who attend the participating hospitals.
Key inclusion criteria (2 listed)
- Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebral aneurysms.
- Signed informed consent by the patient or their representative.
Key exclusion criteria (4 listed)
- Patients under 18 years of age.
- Absence of signed informed consent by the patient or their representative.
- Known, medically untreatable allergy to iodinated contrast.
- Pregnant women or those breastfeeding.
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 |
|---|---|---|
| Group 1 - Intervention 1Endovascular treatment of cerebral aneurysms through the implantation of p64MW HPC and p48MW HPC devices. | Device | Patients treated with p64MW HPC and p48MW HPC |
Primary outcome
Effectiveness objective
Time frame: 1 year
Evaluation of the effectiveness of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.
Safety Objective
Time frame: 1 year
Evaluation of the safety of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.
10 secondary outcomes
Intervention success
Time frame: During the procedure
Thromboembolic complications
Time frame: 1 year
Hemorrhagic complications
Time frame: 1 year
Mortality
Time frame: 1 year
Clinical evolution of the patient using the National Institutes of Health Stroke Scale (NIHSS) and the Modified Rankin Scale (MRS).
Time frame: 1 year
Intimal hyperplasia
Time frame: 1 year
Thromboembolic complications with a single antiplatelet drug
Time frame: 1 year
Intimal hyperplasia with a single antiplatelet drug
Time frame: 1 year
Visible ischemic complications
Time frame: 6 months
Aneurysm occlusion
Time frame: 1 year
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 22 Nov 2024.
- Background: PubMed 17615366Kallmes DF, Ding YH, Dai D, Kadirvel R, Lewis DA, Cloft HJ. A new endoluminal, flow-disrupting device for treatment of saccular aneurysms. Stroke. 2007 Aug;38(8):2346-52. doi: 10.1161/STROKEAHA.106.479576. Epub 2007 Jul 5.
- Background: PubMed 24086073Kadirvel R, Ding YH, Dai D, Rezek I, Lewis DA, Kallmes DF. Cellular mechanisms of aneurysm occlusion after treatment with a flow diverter. Radiology. 2014 Feb;270(2):394-9. doi: 10.1148/radiol.13130796. Epub 2013 Oct 28.
- Background: PubMed 32317371Cancelliere NM, Nicholson P, Radovanovic I, Mendes KM, Orru E, Krings T, Pereira VM. Comparison of intra-aneurysmal flow modification using optical flow imaging to evaluate the performance of Evolve and Pipeline flow diverting stents. J Neurointerv Surg. 2020 Aug;12(8):814-817. doi: 10.1136/neurintsurg-2019-015696. Epub 2020 Apr 21.
- Background: PubMed 24072622Shapiro M, Raz E, Becske T, Nelson PK. Variable porosity of the pipeline embolization device in straight and curved vessels: a guide for optimal deployment strategy. AJNR Am J Neuroradiol. 2014 Apr;35(4):727-33. doi: 10.3174/ajnr.A3742. Epub 2013 Sep 26.
- Background: PubMed 25895510Briganti F, Leone G, Marseglia M, Cicala D, Caranci F, Maiuri F. p64 Flow Modulation Device in the treatment of intracranial aneurysms: initial experience and technical aspects. J Neurointerv Surg. 2016 Feb;8(2):173-80. doi: 10.1136/neurintsurg-2015-011743. Epub 2015 Apr 20.
- Background: PubMed 26272970Fischer S, Aguilar-Perez M, Henkes E, Kurre W, Ganslandt O, Bazner H, Henkes H. Initial Experience with p64: A Novel Mechanically Detachable Flow Diverter for the Treatment of Intracranial Saccular Sidewall Aneurysms. AJNR Am J Neuroradiol. 2015 Nov;36(11):2082-9. doi: 10.3174/ajnr.A4420. Epub 2015 Aug 13.
- Background: PubMed 28236050Morais R, Mine B, Bruyere PJ, Naeije G, Lubicz B. Endovascular treatment of intracranial aneurysms with the p64 flow diverter stent: mid-term results in 35 patients with 41 intracranial aneurysms. Neuroradiology. 2017 Mar;59(3):263-269. doi: 10.1007/s00234-017-1786-2. Epub 2017 Feb 24.
- Background: PubMed 27439887Briganti F, Leone G, Ugga L, Marseglia M, Macera A, Manto A, Delehaye L, Resta M, Resta M, Burdi N, Nuzzi NP, Divenuto I, Caranci F, Muto M, Solari D, Cappabianca P, Maiuri F. Mid-term and long-term follow-up of intracranial aneurysms treated by the p64 Flow Modulation Device: a multicenter experience. J Neurointerv Surg. 2017 Jan;9(1):70-76. doi: 10.1136/neurintsurg-2016-012502. Epub 2016 Jul 20.
- Background: PubMed 33469666Aguilar Perez M, Henkes E, Hellstern V, Serna Candel C, Wendl C, Bazner H, Ganslandt O, Henkes H. Endovascular Treatment of Anterior Circulation Aneurysms With the p64 Flow Modulation Device: Mid- and Long-Term Results in 617 Aneurysms From a Single Center. Oper Neurosurg. 2021 Mar 15;20(4):355-363. doi: 10.1093/ons/opaa425.
- Background: PubMed 32506988De Beule T, Boulanger T, Heye S, van Rooij WJ, van Zwam WH, Stockx L. p64 flow diverter: Results in 108 patients from a single center. Interv Neuroradiol. 2021 Feb;27(1):51-59. doi: 10.1177/1591019920932048. Epub 2020 Jun 6.
- Background: PubMed 28488025Aguilar Perez M, Bhogal P, Henkes E, Ganslandt O, Bazner H, Henkes H. In-stent Stenosis after p64 Flow Diverter Treatment. Clin Neuroradiol. 2018 Dec;28(4):563-568. doi: 10.1007/s00062-017-0591-y. Epub 2017 May 9.
- Background: PubMed 31399749Sirakov S, Sirakov A, Bhogal P, Penkov M, Minkin K, Ninov K, Hristov H, Karakostov V, Raychev R. The p64 Flow Diverter-Mid-term and Long-term Results from a Single Center. Clin Neuroradiol. 2020 Sep;30(3):471-480. doi: 10.1007/s00062-019-00823-y. Epub 2019 Aug 9.
- 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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Aneurysm and Thromboembolic Disease, run by Hospital Universitario Central de Asturias at 11 sites in Spain.
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 2 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: looking for participants now, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. 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 PEDRO VEGA VALDES, MD, PhD (0034985108000 ext. 39116, peveval@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness objective (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT06201598, which also lists 16 linked publications.
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 22 Nov 2024.