Aneurysm Wall Histology Registry
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01444664 |
Recruitment Status
:
Completed
First Posted
: October 3, 2011
Last Update Posted
: March 24, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Aneurysm | Procedure: Surgical Clipping of Aneurysm | Phase 4 |
To design a registry to evaluate the wall of intracranial aneurysms during open surgical clipping by direct photographic appearance, wall biopsy samples, CSF and blood plasma fluid collection (Interleukins; IL-8/ Matrix Metalloproteinase; MMP-9) for complete evaluation and comparison.
The focus of the registry will be to determine the presence of aneurysmal wall defects, mural clot, atherosclerotic and atheroma, wall permeability and delamination. These findings will then be correlated to the collected CSF and blood values to determine if there is any direct features of the aneurysm wall that would predict any of the reported post embolic syndromes. The collected data can also be correlated to the peroperative imaging, (MRI, CT and Angiogram).
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Aneurysm Wall Histology and Correlation With Cerebrospinal Fluid and Blood Plasma Registry |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Aneurysm |
Procedure: Surgical Clipping of Aneurysm
Surgical clipping of intracranial aneurysm
|
- Histological Change [ Time Frame: an average of 1 day after aneurysm treatment an analysis of the histological sample, CSF sample, and plasma samples will occur ]To determine the relative and absolute differences in histological changes as seen in the tissue samples comparing this to the CSF and blood plasma samples. To also determine if there is any gene expressions that can be utilized as predictive markers in this cohort of patients.
- Treatment related morbidity and mortality [ Time Frame: up to approximately 1 year post treatment ]Secondary analyses will be performed to compare treatment related morbidity and mortality,
- Clinical Outcome [ Time Frame: approximately clinical outcome at 6 months after surgical clipping at routine follow up visit and approximately 12 months after clipping at routine follow up visit if indicated ]clinical outcome at approximately 6 months after surgical clipping at routine follow up visit and approximately 12 months after clipping at routine follow up visit if indicated
- Bleeding Rate [ Time Frame: post treatment during approximate follow up periods 6mo and 12mo clinical follow up ]bleeding rate post treatment.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient > 18 years but < 80 years of age
- Patient with an unruptured Intracranial aneurysm 8mm or larger
- Patient that surgical exposure and clipping will be the primary treatment option
Exclusion Criteria:
- Any patient that has a ruptured intracranial aneurysm
- Any Pediatric patients
-
Any patient presenting with any pre-treatment intracranial lesions
- Vascular malformations
- Hemorrhage
- Normal Pressure Hydrocephalus
- Obstructive Hydrocephalus
- White matter disease
- Tumors
- Trauma
- Other vascular type lesions
- Any meningitis type symptoms
- Medical or surgical co-morbidities such that the patient's life expectancy is less than 1 year
- Inability to obtain consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444664
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
University Of Illinois | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Goodman Campbell | |
Indianapolis, Indiana, United States, 46202 | |
United States, New York | |
Albany Medical Center | |
Albany, New York, United States, 12208-3412 | |
SUNY - Stonybrook University Medical Center | |
Stonybrook, New York, United States, 11794 | |
United States, Oregon | |
Providence Health | |
Portland, Oregon, United States, 97225 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29401 | |
United States, Tennessee | |
Methodist Healthcare - Memphis | |
Memphis, Tennessee, United States, 38104 | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37240 | |
Canada, Ontario | |
Royal University Hospital | |
Saskatoon, Ontario, Canada, S7N OW8 |
Principal Investigator: | Henry Woo | SUNY - Stonybrook | |
Principal Investigator: | Arthur Adam, MD | Baptist Hospital | |
Principal Investigator: | Mike Kelly | Royal University Hospital Foundation |
Publications:
Responsible Party: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT01444664 History of Changes |
Other Study ID Numbers: |
20137 |
First Posted: | October 3, 2011 Key Record Dates |
Last Update Posted: | March 24, 2016 |
Last Verified: | April 2015 |
Additional relevant MeSH terms:
Aneurysm Intracranial Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |