The International PERForator ANeurysm Registry (PERFAN)

NCT06189014 | Unknown

• 1 other identifier: 2023-01778
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this international, multicenter, mixed retrospective-prospective, exploratory, observational study is to establish an international registry to fill the knowledge gap created by the rarity of lenticulostriate and basilar perforator aneurysms and the resulting lack of knowledge about their natural history, diagnostic evaluation, management, and clinical outcomes. Specifically, comparative analyses of outcomes in patients with intracranial perforator aneurysms treated conservatively, endovascularly, and surgically will be performed. The study will also evaluate the size and location of lenticulostriate and basilar intracranial perforator aneurysms, collect information on the specific type of endovascular treatment used, compare patients with predominantly perimesencephalic subarachnoid hemorrhage (SAH) who have a perforator aneurysm to those without, and evaluate spontaneous occlusion in conservatively treated aneurysms. Core lab analysis of these aneurysms on various imaging modalities will be performed at the Inselspital and changes in aneurysm characteristics over time will be documented. In addition, the relationship between baseline characteristics and aneurysm characteristics on the incidence of hemorrhage will be examined. The study will involve approximately 20-30 centers worldwide with an estimated total sample size of 200-300 patients by 2025.

Conditions

Aneurysm, Brain

Keywords

Perforator Aneurysm; Natural History; Treatment Options; Outcomes

Outcome Measures

Primary Outcomes (8)

• mRS at 3 months after initial diagnosis of an intracranial perforator aneurysm

  90 days

• mRS at last follow-up (including time-point of last follow-up after diagnosis)

  Last follow-up, expected to be on average 2 years

• Rupture/re-rupture of the index aneurysm as a time-event outcome

  Date of rupture/re-rupture

• Death during the acute hospital stay

  Until patient discharge, up to 4 weeks

• Death up to 90 days (related to the index aneurysm)

  90 days

• Number of participants with ischemic stroke (imaging based)

  Follow-up, expected to be up to 7 days

• Periprocedural and postprocedural complications in patients submitted to endovascular or surgical treatment

  Peri-/postprocedural, expected to be up to 24 hours

• For patients receiving treatment, assessment of aneurysm occlusion after treatment and available follow-ups

  First follow-up, expected to be within 7 days

Eligibility Criteria

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

Study Population

Patients.

You may qualify if:

• Patients from the Inselspital and from participating centers worldwide, who have been diagnosed or will be diagnosed with one or more lenticulostriate, basilar and/or other intracranial perforator aneurysms (starting from January 1st, 2013).
• Patients aged ≥18 years
• Written informed consent

You may not qualify if:

• Presence of documented written or verbal refusal.
• Aneurysm arising from the middle cerebral artery trunk which does not incorporate a lenticulostriate artery (Vargas Type 1), as they are not perforator aneurysms by strict definition.
• Aneurysm arising from the basilar artery trunk adjacent to a perforating branch but not involving a perforating artery (Satti Type 1), as they are not perforator aneurysms by strict definition.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Institute of Diagnostic and Interventional Neuroradiology, Inselspital Bern

Bern, 3010, Switzerland

RECRUITING

Related Publications (14)

• Elsheikh S, Mohlenbruch M, Seker F, Berlis A, Maurer C, Kocer N, Jamous A, Behme D, Taschner C, Urbach H, Meckel S. Flow Diverter Treatment of Ruptured Basilar Artery Perforator Aneurysms : A Multicenter Experience. Clin Neuroradiol. 2022 Sep;32(3):783-789. doi: 10.1007/s00062-021-01133-y. Epub 2022 Jan 20.

  PMID: 35059755 BACKGROUND

• Gandhi CD, Gilad R, Patel AB, Haridas A, Bederson JB. Treatment of ruptured lenticulostriate artery aneurysms. J Neurosurg. 2008 Jul;109(1):28-37. doi: 10.3171/JNS/2008/109/7/0028.

  PMID: 18590430 BACKGROUND

• Granja MF, Monteiro A, Agnoletto GJ, Jamal S, Sauvageau E, Aghaebrahim A, Hanel R. A systematic review of non-trunk basilar perforator aneurysms: is it worth chasing the small fish? J Neurointerv Surg. 2020 Apr;12(4):412-416. doi: 10.1136/neurintsurg-2019-015311. Epub 2019 Oct 9.

  PMID: 31597686 BACKGROUND

• Hinojosa-Gonzalez DE, Ferrigno AS, Martinez HR, Farias JS, Caro-Osorio E, Figueroa-Sanchez JA. Aneurysms of the Lenticulostriate Artery: A Systematic Review. World Neurosurg. 2021 Jan;145:471-479.e10. doi: 10.1016/j.wneu.2020.08.160. Epub 2020 Sep 2.

  PMID: 32889194 BACKGROUND

• Lu GD, Zhao LB, Jia ZY, Liu S. Micro-guidewire electrocoagulation for the treatment of intracranial aneurysms that are inaccessible by microcatheterization: a case series and review of the literature. J Neurointerv Surg. 2023 Dec;15(12):1229-1233. doi: 10.1136/jnis-2022-019355. Epub 2022 Oct 25.

  PMID: 36283807 BACKGROUND

• Ma H, Zhao R, Fang Y, Li Q, Yang P, Huang Q, Xu Y, Hong B, Liu JM. Endovascular electrothrombosis: A promising alternative for basilar artery perforator aneurysm treatment. Interv Neuroradiol. 2021 Aug;27(4):511-515. doi: 10.1177/1591019920987913. Epub 2021 Jan 12.

  PMID: 33435781 BACKGROUND

• Mutlu U, Kortman H, Boukrab I. A giant basilar artery perforator aneurysm. Radiol Case Rep. 2022 Jan 14;17(3):911-913. doi: 10.1016/j.radcr.2021.12.034. eCollection 2022 Mar.

  PMID: 35069959 BACKGROUND

• Roccatagliata L, Pileggi M, Cianfoni A, Gralla J. Ruptured lenticulostriate artery aneurysm: a report of a case treated with endovascular embolisation. BMJ Case Rep. 2020 Oct 7;13(10):e236649. doi: 10.1136/bcr-2020-236649.

  PMID: 33028571 BACKGROUND

• Shlobin NA, Cantrell DR, Ansari SA, Hurley MC, Shaibani A, Jahromi BS, Potts MB. Conservative Management and Natural History of Ruptured Basilar Perforator Artery Aneurysms: Two Cases and Literature Review. World Neurosurg. 2020 Jun;138:218-222. doi: 10.1016/j.wneu.2020.03.042. Epub 2020 Mar 16.

  PMID: 32194275 BACKGROUND

• Vargas J, Walsh K, Turner R, Chaudry I, Turk A, Spiotta A. Lenticulostriate aneurysms: a case series and review of the literature. J Neurointerv Surg. 2015 Mar;7(3):194-201. doi: 10.1136/neurintsurg-2013-010969. Epub 2014 Feb 26.

  PMID: 24574545 BACKGROUND

• Wu Y, Li Z, Yang D, Wu T, Chen A, Dai C, Zhu Q. Spontaneous subarachnoid hemorrhage caused by ruptured aneurysm of basilar trunk perforator: a case report and literature review. Chin Neurosurg J. 2022 Jun 10;8(1):14. doi: 10.1186/s41016-022-00281-5.

  PMID: 35681227 BACKGROUND

• Young M, Schaible P, Asi K, Schaible K. Ruptured Distal Medial Lenticulostriate Artery Aneurysm Treated With Transcortical-Transventricular Approach. Cureus. 2021 Jul 5;13(7):e16186. doi: 10.7759/cureus.16186. eCollection 2021 Jul.

  PMID: 34367793 BACKGROUND

• Kumagawa T, Otani N, Kakei Y, Negishi H, Suma T, Yoshino A. Ruptured Basilar Artery Perforator Aneurysm Definitely Diagnosed with Intraoperative Microsurgical Findings: Case Report and Literature Review. NMC Case Rep J. 2023 Jan 16;10:1-7. doi: 10.2176/jns-nmc.2022-0184. eCollection 2023.

  PMID: 36778213 BACKGROUND

• van Gijn J, Rinkel GJ. Subarachnoid haemorrhage: diagnosis, causes and management. Brain. 2001 Feb;124(Pt 2):249-78. doi: 10.1093/brain/124.2.249.

  PMID: 11157554 BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Study Officials

• Tomas Dobrocky, PD, MD

  Institute of Diagnostic and Interventional Neuroradiology, Inselspital Bern

  PRINCIPAL INVESTIGATOR

• Johannes Kaesmacher, Prof, MD, PhD

  Institute of Diagnostic and Interventional Neuroradiology, Inselspital Bern

  PRINCIPAL INVESTIGATOR

• Bettina L. Serrallach, MD

  Institute of Diagnostic and Interventional Neuroradiology, Inselspital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas Dobrocky, PD, MD

CONTACT

+41 31 63 2 68 81; perfan@insel.ch

Bettina L. Serrallach, MD

CONTACT

+41 31 63 2 78 69; perfan@insel.ch

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: January 3, 2024
• Study Start: November 9, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)