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

NCT06201598 | Recruiting

• 1 other identifier: 2023.014
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Cerebral Aneurysm; Thromboembolic Disease

Keywords

Cerebral aneurysm; Flow-diverting stents; Thrombogenicity; p64 MW HPC; p48 MW HPC

Outcome Measures

Primary Outcomes (2)

• Effectiveness objective

  Evaluation of the effectiveness of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.

  1 year

• Safety Objective

  Evaluation of the safety of treating cerebral aneurysms with p64MW HPC and p48MW HPC devices in several Spanish hospitals.

  1 year

Secondary Outcomes (10)

• Intervention success

  During the procedure

• Thromboembolic complications

  1 year

• Hemorrhagic complications

  1 year

• Mortality

  1 year

• Clinical evolution of the patient using the National Institutes of Health Stroke Scale (NIHSS) and the Modified Rankin Scale (MRS).

  1 year

Study Arms (1)

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.

Device: Group 1 - Intervention 1

Interventions

Group 1 - Intervention 1 DEVICE

Endovascular treatment of cerebral aneurysms through the implantation of p64MW HPC and p48MW HPC devices.

Patients treated with p64MW HPC and p48MW HPC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Patients over 18 years old with incidental, symptomatic, and/or ruptured cerebral aneurysms.
• Signed informed consent by the patient or their representative.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Central de Asturias: lead

Study Sites (11)

Hospital Universitario de A Coruña

A Coruña, 15006, Spain

RECRUITING

Hospital Universitari Germans Trias I Pujol

Badalona, 08916, Spain

RECRUITING

Hospital Universitari Vall D Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario de Burgos

Burgos, 09006, Spain

RECRUITING

Hospital Universitario de Donostia

Donostia / San Sebastian, 20014, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Regional Universitario de Malaga

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, 33006, Spain

RECRUITING

Hospital Parc Tauli

Sabadell, 08208, Spain

RECRUITING

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

Related Publications (16)

• 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.

  PMID: 17615366 BACKGROUND

• 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.

  PMID: 24086073 BACKGROUND

• 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.

  PMID: 32317371 BACKGROUND

• 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.

  PMID: 24072622 BACKGROUND

• 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.

  PMID: 25895510 BACKGROUND

• 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.

  PMID: 26272970 BACKGROUND

• 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.

  PMID: 28236050 BACKGROUND

• 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.

  PMID: 27439887 BACKGROUND

• 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. 2021 Mar 15;20(4):355-363. doi: 10.1093/ons/opaa425.

  PMID: 33469666 BACKGROUND

• 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.

  PMID: 32506988 BACKGROUND

• 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.

  PMID: 28488025 BACKGROUND

• 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.

  PMID: 31399749 BACKGROUND

• 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.

  PMID: 34782399 BACKGROUND

• 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.

  PMID: 31838537 BACKGROUND

• 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.

  PMID: 30039502 BACKGROUND

• 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.

  PMID: 35562486 BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm; Thromboembolism

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Central Study Contacts

PEDRO VEGA VALDES, MD, PhD

CONTACT

0034985108000; peveval@yahoo.es

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PEDRO VEGA VALDES

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 11, 2024
• Study Start: January 12, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (11)