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Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms (PAOCA)

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Capital Medical University

Status

Unknown

Conditions

Printing, Three-Dimensional, Simulation Training

Treatments

Procedure: Printing, Three-Dimensional

Study type

Interventional

Funder types

Other

Identifiers

NCT02977520
TWKY-2016-ZD-01-10

Details and patient eligibility

About

Cerebral aneurysm is one of the main diseases that seriously affect human health. The most important treatment method is surgical clipping and endovascular embolization. Not complete occlusion of the aneurysm is a main risk of recurrence and rebleeding after treatment. This study is focused on the 3D model of cerebral aneurysms and preoperative evaluation. Combined with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In addition, the model can also be used to the young doctor's training, and the patient and their families can be convenient and intuitive understanding of the disease, so as to form a good communication between doctors and patients.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age: 18 years-80 years;
  • Hunt-Hess grade: 0-4;
  • Without other stroke, brain trauma and other neurological disease;
  • Without cerebral hernia;
  • Cystic aneurysm.

Exclusion criteria

  • Age: less than 18 years or above 80 years;
  • Hunt-Hess grade is 5;
  • With serious previous disorder of multiple organ;
  • Acute cerebral hernia;
  • Aneurysms were fusiform or serpentine expansion.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Interventional group
Experimental group
Description:
Obtain the CTA data of cerebral aneurysms and built the 3D printing models. Combined with the 3D model, the neurosurgeon can complete the discussion of preoperative prediction of aneurysms and recognize the adjacent bone, blood vessels, aneurysm directions and so on. In addition, the model can also be used to the young doctor's training, and the patient and their families can be convenient and intuitive understanding of the disease, so as to form a good communication between doctors and patients.
Treatment:
Procedure: Printing, Three-Dimensional
general group
No Intervention group
Description:
Obtain the CTA data of cerebral aneurysms, the neurosurgeon complete the discussion of preoperative prediction of aneurysms.

Trial contacts and locations

1

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Central trial contact

QING HUANG, M.D.; YANLONG HU, M.D.

Data sourced from clinicaltrials.gov

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