Reduction in Volume and Prolonged Shrinkage of Brain Aneurysms After Combined Endovascular Interventions

NCT06541275 | Enrolling By Invitation

• 1 other identifier: 20240718-03
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the long-term effects of combined endovascular interventions in participants over the age of 18 who take endovascular interventions employing endoluminal flow diverter stents, with or without coils, and a hybrid approach of combining bypass anastomosis and parent artery occlusion using the endovascular method to treat their giant symptomatic intracranial aneurysms. The main question it aims to answer is: • How does the methods of endovascular intervention chosen affect the value of the aneurysmal sac shrinkage and volume reduction? Participants underwent endovascular intervention at the hospital will be recruited with further follow-up of 6, 12, and 24 months.

Conditions

Brain Aneurysm

Keywords

brain aneurysm; endovascular flow diverters; neurovascular

Outcome Measures

Primary Outcomes (1)

• A value of the aneurysmal sac shrinkage and volume reduction

  A detailed analysis and interpretation of the results obtained from selective cerebral angiography and MRA post-surgery at 6, 12, and 24 months will be performed on participants who underwent endovascular interventions for giant symptomatic brain aneurysms. The analysis will assess the dynamic volume reduction and sac shrinkage.

  From enrollment to the further follow-up of 6, 12, and 24 months.

Interventions

brain MRI and CT DIAGNOSTIC_TEST

The diagnostic tests will be conducted at 6, 12, and 24 months of follow-up.

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

Study population involves participants who were treated at the Vascular and Functional Neurosurgery Department of the National Centre for Neurosurgery in Astana, Kazahstan.

You may qualify if:

• Participants aged 18 years and older;
• Participants with large and giant intracranial aneurysms and underwent endovascular interventions within the last 5 years (2019-2023).

You may not qualify if:

• Participants under the age of 18;
• Participants with small intracranial aneurysms in the anamnesis and underwent microsurgery.

Sponsors & Collaborators

• National Centre for Neurosurgery, Republic of Kazakhstan: lead

Study Sites (1)

National Centre for Neurosurgery

Astana, 010000, Kazakhstan

Location

Related Publications (10)

• Pasqui E, de Donato G, Molino C, Abu Leil M, Anzaldi MG, Galzerano G, Palasciano G. Residual Aneurysmal Sac Shrinkage Post-Endovascular Aneurysm Repair: The Role of Preoperative Inflammatory Markers. Biomedicines. 2023 Jul 6;11(7):1920. doi: 10.3390/biomedicines11071920.

  PMID: 37509562 RESULT

• Mitsui T, Nakagawa I, Kotsugi M, Park H, Yokoyama S, Myouchin K, Nakase H. Remarkable shrinkage of a thrombosed giant aneurysm by stent-assisted jam-packed coil embolization. Surg Neurol Int. 2021 Jul 6;12:328. doi: 10.25259/SNI_511_2021. eCollection 2021.

  PMID: 34345469 RESULT

• Akiyama R, Ishii A, Kikuchi T, Okawa M, Yamao Y, Abekura Y, Ono I, Sasaki N, Tsuji H, Matsukawa S, Miyamoto S. Predictors of aneurysm shrinkage after flow diversion treatment for internal carotid artery aneurysms: quantitative volume analysis with MRI. Front Neurol. 2023 Dec 21;14:1266460. doi: 10.3389/fneur.2023.1266460. eCollection 2023.

  PMID: 38187156 RESULT

• Makhambetov Y, Kaliyev A, Kikuta KI, Smagulov F, Medetov Y, Kulmirzayev M, Kerimbayev T, Kissamedenov N, Tursynkhan A, Doskaliyev A, Akshulakov S. Early and midterm results of treatment of giant internal carotid artery paraclinoid aneurysms with trapping and flow diverters. Acta Neurochir (Wien). 2019 Sep;161(9):1755-1761. doi: 10.1007/s00701-019-04002-3. Epub 2019 Jul 15.

  PMID: 31309305 RESULT

• Kaliyev A, Makhambetov Y, Medetov Y, Kulmirzayev M, Dusembayev S, Nurimanov C, Kunakbayev B, Akshulakov S. Management of giant internal carotid aneurysm by extracranial-intracranial bypass and flow diverter stent. Br J Neurosurg. 2023 Dec;37(6):1893-1897. doi: 10.1080/02688697.2021.1947974. Epub 2021 Jul 8.

  PMID: 34236251 RESULT

• Dutta G, Singh D, Jagetia A, Srivastava AK, Singh H, Kumar A. Endovascular management of large and giant intracranial aneurysms: Experience from a tertiary care neurosurgery institute in India. J Cerebrovasc Endovasc Neurosurg. 2021 Jun;23(2):99-107. doi: 10.7461/jcen.2021.E2020.08.008. Epub 2021 May 17.

  PMID: 33993689 RESULT

• Lawton MT, Spetzler RF. Surgical management of giant intracranial aneurysms: experience with 171 patients. Clin Neurosurg. 1995;42:245-66.

  PMID: 8846596 RESULT

• Moon E, Park W, Song Y, Lee DH, Ahn JS, Park JC. Mass Effect After Flow Diversion for Unruptured Large and Giant Cavernous or Paraclinoid Internal Carotid Artery Aneurysm. World Neurosurg. 2023 Dec;180:e108-e116. doi: 10.1016/j.wneu.2023.08.129. Epub 2023 Sep 9.

  PMID: 37690582 RESULT

• Lonjon M, Pennes F, Sedat J, Bataille B. Epidemiology, genetic, natural history and clinical presentation of giant cerebral aneurysms. Neurochirurgie. 2015 Dec;61(6):361-5. doi: 10.1016/j.neuchi.2015.08.003. Epub 2015 Dec 1.

  PMID: 26598391 RESULT

• Cagnazzo F, Mantilla D, Rouchaud A, Brinjikji W, Lefevre PH, Dargazanli C, Gascou G, Riquelme C, Perrini P, di Carlo D, Bonafe A, Costalat V. Endovascular Treatment of Very Large and Giant Intracranial Aneurysms: Comparison between Reconstructive and Deconstructive Techniques-A Meta-Analysis. AJNR Am J Neuroradiol. 2018 May;39(5):852-858. doi: 10.3174/ajnr.A5591. Epub 2018 Mar 15.

  PMID: 29545248 RESULT

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 Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Hospital Management Department

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: July 17, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

KA (1)