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

Sponsor
Beijing Luhe Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02977520
Collaborator
(none)
40
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Printing, Three-Dimensional
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Preoperative Assessment and Individualized Operation Optimization of Acute Ruptured Cerebral Aneurysms
Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
May 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interventional group

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.

Procedure: Printing, Three-Dimensional
To establish 3D model of cerebral aneurysms and have preoperative evaluation.
No Intervention: general group

Obtain the CTA data of cerebral aneurysms, the neurosurgeon complete the discussion of preoperative prediction of aneurysms.

Outcome Measures

Primary Outcome Measures

  1. time of operation [1 to 3 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Luhe hospital Beijing Beijing China 101149

Sponsors and Collaborators

  • Beijing Luhe Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing Luhe Hospital
ClinicalTrials.gov Identifier:
NCT02977520
Other Study ID Numbers:
  • TWKY-2016-ZD-01-10
First Posted:
Nov 30, 2016
Last Update Posted:
Nov 30, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms:
Intracranial Aneurysm
Aneurysm

Study Results

No Results Posted as of Nov 30, 2016