Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2015-10-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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Fusion oxygenation system
Fusion oxygenation machine will be used during the operation.
fusion oxygenation system
The fusion oxygenation system is a novel design of the pump oxygenator used in cardiopulmonary bypass, integrating multiple new engineering concepts that have altered its performance profile.
Affinity oxygenation system
Affinity oxygenation machine will be used during the operation.
Affinity oxygenation system
The affinity oxygenation system is the classical pump oxygenator used in cardiopulmonary bypass surgeries
Peripheral vascular procedure
No oxygenation machine will be used in this group
No interventions assigned to this group
percutaneous coronary intervention
No oxygenation machine will be used in this group
No interventions assigned to this group
Interventions
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fusion oxygenation system
The fusion oxygenation system is a novel design of the pump oxygenator used in cardiopulmonary bypass, integrating multiple new engineering concepts that have altered its performance profile.
Affinity oxygenation system
The affinity oxygenation system is the classical pump oxygenator used in cardiopulmonary bypass surgeries
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing elective peripheral vascular surgical procedures under general anesthesia
* Patients undergoing elective percutaneous coronary intervention will serve as control groups
Exclusion Criteria
* Left ventricular ejection fraction less than 30%
* CABG with concomitant procedure
* Previous stroke or documented neurological disorder
* High grade (\>70%) unilateral or bilateral carotid stenosis
* Contraindication to MRI testing.
18 Years
75 Years
ALL
No
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Oz Shapira
DIRECTOR OF THE DEPARTMENT OF CARDIOTHORACIC SURGERY
Principal Investigators
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Oz Shapira, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Central Contacts
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Other Identifiers
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0033-15-HMO
Identifier Type: -
Identifier Source: org_study_id
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