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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ACTIVE_NOT_RECRUITING
30 participants
OBSERVATIONAL
2022-05-11
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Impella 5.5 with SmartAssist Supported OPCABG
Subjects will undergo insertion of an axillary or ascending aortic Impella 5.5 with SmartAssist, followed by Impella-supported OPCABG using a sternotomy approach with shunting of the coronary arteries to achieve myocardial protection.
Eligibility Criteria
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Inclusion Criteria
* Ejection fraction ≤ 35%
* Symptomatic three vessel Coronary Artery Disease with target vessels that are amenable to bypass (as determined by the operating surgeon) or Left main disease
* Adequate Distal target caliber (as determined by the PI or operating surgeon)
Exclusion Criteria
* Patients with cardiogenic shock who require a period of short-term mechanical circulatory support
* Patients with mechanical aortic valve
* Patients with previous median sternotomy
* Patients with evidence of non-viability on preoperative cardiac MRI or CT scan
* Insufficient conduit
* BMI over 50
* Suspected or known pregnancy
18 Years
ALL
No
Sponsors
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Abiomed Inc.
INDUSTRY
Lucian Archambault Durham III
OTHER
Responsible Party
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Lucian Archambault Durham III
Lucian Durham, MD, PhD
Principal Investigators
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Lucian A Durham, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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37481
Identifier Type: -
Identifier Source: org_study_id
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