Personalized Treatment Planning in Intracranial Aneurysm Surgeries.

NCT05324605 | Completed

• 1 other identifier: 3 D
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who will undergo a intracranial aneurysm (IA) surgery are educated concerning their disease and the surgical procedure.The objective of this study is to explore the advantages of conventional, virtual reality and 3D stereolithographic models for patient and resident education in the treatment of lAs.

Conditions

Aneurysm Cerebral

Outcome Measures

Primary Outcomes (1)

• accuracy of the planned intervention and clip placement.

  Assessment of the 3D models regarding the accuracy of the planned intervention. In specific the following surgical steps are evaluated and assessed during aneurysm clipping and compared to the ideal preoperative forecast based on the 3D model (GRF\_clip anticipation): Temporary clips: (1) number of temporary clips; (2) left- or right-handed application; (3) position on parent artery; (4) length of the clip; (5) shape of the clip. Permanent clips: (6) number of permanent clips; (7) left- or right-handed application; (8) length of the clip; (9) shape of the clip.

  6 months post interventional

Secondary Outcomes (1)

• patient education

  6 months post interventional

Interventions

Questionnaire and use of 3 D tools PROCEDURE

Resulting computer tomography(CT) results are transferred to a 3 D projection. Patients will be asked to wear 3 D glasses to be able visualizing the diagnosed vascular pathology. The physician will explain the disaese and treatment. The patient is ask to fill out a questionnaire post 3D consulting

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

The study population are patient with a age \>18 years, diagnosed with a intracranial aneurysma , requiring surgery. The eligibility is evaluated and prior surgery, preoperative assessment by CTA and 3D-DSA have been performed. After screening a non routine consultation with the 3 D method visualization is scheduled. Finally, patients will be scheduled for surgery according to our standard procedure.

You may not qualify if:

• Patients with ruptured or mycotic IA are not considered. Furthermore, patients elected for IA surgery that are younger than 18 years old, as well as patients who are unable to give informed consent (e.g. neurological impairments) will not be included.

Sponsors & Collaborators

• Prof. Dr. med. Serge Marbacher: lead
• Kantonsspital Aarau: collaborator

Study Sites (1)

Kantonsspital Aarau AG

Aarau, Canton of Aargau, 5001, Switzerland

Location

Related Publications (7)

• Vlak MH, Algra A, Brandenburg R, Rinkel GJ. Prevalence of unruptured intracranial aneurysms, with emphasis on sex, age, comorbidity, country, and time period: a systematic review and meta-analysis. Lancet Neurol. 2011 Jul;10(7):626-36. doi: 10.1016/S1474-4422(11)70109-0.

  PMID: 21641282 BACKGROUND

• Andereggen L, Gralla J, Andres RH, Weber S, Schroth G, Beck J, Widmer HR, Reinert M, Raabe A, Peterhans M. Stereolithographic models in the interdisciplinary planning of treatment for complex intracranial aneurysms. Acta Neurochir (Wien). 2016 Sep;158(9):1711-20. doi: 10.1007/s00701-016-2892-3. Epub 2016 Jul 14.

  PMID: 27416860 BACKGROUND

• Kimura T, Morita A, Nishimura K, Aiyama H, Itoh H, Fukaya S, Sora S, Ochiai C. Simulation of and training for cerebral aneurysm clipping with 3-dimensional models. Neurosurgery. 2009 Oct;65(4):719-25; discussion 725-6. doi: 10.1227/01.NEU.0000354350.88899.07.

  PMID: 19834377 BACKGROUND

• Russin J, Babiker H, Ryan J, Rangel-Castilla L, Frakes D, Nakaji P. Computational Fluid Dynamics to Evaluate the Management of a Giant Internal Carotid Artery Aneurysm. World Neurosurg. 2015 Jun;83(6):1057-65. doi: 10.1016/j.wneu.2014.12.038. Epub 2014 Dec 22.

  PMID: 25541083 BACKGROUND

• Slichter SJ. Platelet transfusion therapy. Hematol Oncol Clin North Am. 1990 Feb;4(1):291-311.

  PMID: 2179213 BACKGROUND

• Tanabe J, Ishikawa T, Moroi J, Sakata Y, Hadeishi H. Impact of Right-Sided Aneurysm, Rupture Status, and Size of Aneurysm on Perforator Infarction Following Microsurgical Clipping of Posterior Communicating Artery Aneurysms with a Distal Transsylvian Approach. World Neurosurg. 2018 Mar;111:e905-e911. doi: 10.1016/j.wneu.2018.01.002. Epub 2018 Jan 8.

  PMID: 29325945 BACKGROUND

• Roszelle BN, Babiker MH, Hafner W, Gonzalez LF, Albuquerque FC, Frakes DH. In vitro and in silico study of intracranial stent treatments for cerebral aneurysms: effects on perforating vessel flows. J Neurointerv Surg. 2013 Jul;5(4):354-60. doi: 10.1136/neurintsurg-2012-010322. Epub 2012 Jun 26.

  PMID: 22735859 BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 12, 2022
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)