Status:
UNKNOWN
Clinical Evaluation of LeGoo™ Internal Vessel Occluder Versus Traditional Vessel Loops
Lead Sponsor:
Pluromed, Inc.
Conditions:
Off Pump Coronary Artery Bypass Surgery
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
The primary purpose of this study is to demonstrate the clinical safety and efficacy of LeGoo™ in comparison to a standard vessel occlusion method (i.e. vessel loops). Although LeGoo™ is suitable for ...
Detailed Description
The purpose of this study is to evaluate the clinical efficacy of LeGoo™ as compared to a traditional vessel loop. LeGoo is a device that is intended to be used during surgical procedures to temporari...
Eligibility Criteria
Inclusion
- Subjects undergoing elective off pump coronary artery bypass (OPCAB) surgery where the surgeon prospectively plans to use a vascular occlusion device.
- \>70% proximal stenosis of at least one target coronary artery, other than left main
- Age: between the ages 18 -79 years
- Gender: male and female
- Subject is willing and able to participate in a clinical research study and provides informed consent.
- Subject is able and willing to participate in required follow-up procedures.
Exclusion
- Previous cardiac surgery.
- Left ventricular dysfunction (EF \<40%)
- \>50% of left main coronary artery stenosis
- Subjects with a logistic EuroScore equal to or greater than 10% as calculated by the euroscore.org calculator
- Emergent Surgery: Subjects undergoing surgery before the start of the next working day following catheterization
- Creatinine \> 200 µmol/L
- Bilirubin \> 21 µmol/L
- Subjects with chronic pulmonary disease \[ FEV1 \< 45% \]
- Any subject who is deemed by the investigator, for any reason, not suitable or able to participate in a clinical research study.
- Pregnant women. Women of childbearing age will require a pregnancy test within 10 days of the operation and will be excluded if the result is positive.
- Women who are lactating.
- Subjects who have undergone other investigational therapy within 30 days prior to the operation or who are scheduled to receive investigational therapy within six months of the operation.
- Subjects suspected to have one intra-myocardial artery among the coronary arteries to be bypassed during that surgery.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00985634
Start Date
September 1 2008
End Date
March 1 2010
Last Update
September 28 2009
Active Locations (1)
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1
Klinik fur Herzchirurgie Herzzentrum Leipzig
Leipzig, Germany