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

Cerebral Aneurysm Clinical Trial

— pSPAIN_HPC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06201598
• Other study ID #: 2023.014
• Status: Recruiting
• Start date: January 12, 2024
• Est. completion date: December 15, 2025

Study information

• Verified date: January 2024
• Source: Hospital Universitario Central de Asturias
• Contact: PEDRO VEGA VALDES, MD, PhD
• Phone: 0034985108000
• Email: peveval[@]yahoo.es
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm
• Thromboembolic Disease
• Thromboembolism

Intervention

Device:
• Group 1 - Intervention 1
Endovascular treatment of cerebral aneurysms through the implantation of p64MW HPC and p48MW HPC devices.

Locations

Country	Name	City	State
Spain	Hospital Universitario de A Coruña	A Coruña
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Parc Tauli	Sabadell

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Central de Asturias

Country where clinical trial is conducted

Spain, 

References & Publications (16)

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

Outcome

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