Cerebral Aneurysm Clinical Trial
— pSPAIN_HPCOfficial 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
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 15, 2025 |
Est. primary completion date | December 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebral aneurysms. - Signed informed consent by the patient or their representative. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario de A Coruña | A Coruña | |
Spain | Hospital Universitari Vall D Hebron | Barcelona | |
Spain | Hospital Universitario de Donostia | Donostia | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario Central de Asturias | Oviedo | |
Spain | Hospital Parc Tauli | Sabadell | |
Spain | Hospital Universitario Miguel Servet | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario Central de Asturias |
Spain,
Aguilar 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. — View Citation
Aguilar 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 (Hagerstown). 2021 Mar 15;20(4):355-363. doi: 10.1093/ons/opaa425. — View Citation
Bonafe 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. — View Citation
Briganti 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. — View Citation
Briganti 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. — View Citation
Cancelliere 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. — View Citation
De 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. — View Citation
Fischer 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. — View Citation
Hellstern V, Aguilar Perez M, Henkes E, Donauer E, Wendl C, Bazner H, Ganslandt O, Henkes H. Use of a p64 MW Flow Diverter with Hydrophilic Polymer Coating (HPC) and Prasugrel Single Antiplatelet Therapy for the Treatment of Unruptured Anterior Circulation Aneurysms: Safety Data and Short-term Occlusion Rates. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1364-1374. doi: 10.1007/s00270-022-03153-8. Epub 2022 May 13. — View Citation
Kadirvel 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. — View Citation
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. — View Citation
Lenz-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. — View Citation
Morais 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. — View Citation
Shapiro 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. — View Citation
Sirakov 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. — View Citation
Tonetti DA, Jankowitz BT, Gross BA. Antiplatelet Therapy in Flow Diversion. Neurosurgery. 2020 Jan 1;86(Suppl 1):S47-S52. doi: 10.1093/neuros/nyz391. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness objective | Evaluation of the effectiveness of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals. | 1 year | |
Primary | Safety Objective | Evaluation of the safety of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals. | 1 year | |
Secondary | Intervention success | Rate of the ability to position the stent in the indicated location. | During the procedure | |
Secondary | Thromboembolic complications | Rate of cerebral thromboembolic complications during the intervention and during patient follow-up. | 1 year | |
Secondary | Hemorrhagic complications | Rate of cerebral and systemic hemorrhagic complications during the intervention and during patient follow-up. | 1 year | |
Secondary | Mortality | Mortality rate during patient follow-up. | 1 year | |
Secondary | 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). |
1 year | |
Secondary | 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. | 1 year | |
Secondary | 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. | 1 year | |
Secondary | 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. | 1 year | |
Secondary | Visible ischemic complications | Rate of visible ischemic complications in MRI during patient follow-up (4-6 months). | 6 months | |
Secondary | 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. | 1 year |
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