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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02543047 |
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Date of registration:
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02/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Angioshield Study Feasibility II
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Scientific title:
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THE ANGIOSHIELD STUDY:Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02543047 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Lithuania
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Contacts
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Name:
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Gintaras Kalinauskas, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Santariskiu University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Subject will be eligible for inclusion in the investigation if he/she:
1. is between the ages of 18 and 80 years of age, inclusive
2. requires CABG surgery due to atherosclerotic coronary artery disease with minimum of
two SVGs, one used to bypass a stenosis in the main Right Coronary artery and one used
to bypass a stenosis in the Circumflex artery territory
3. is able to give their informed written consent
4. is willing and able to complete all follow-up visits and procedures
5. is to be treated via a medial sternotomy with cardio-pulmonary bypass during surgery
6. has adequate saphenous veins
7. Is a candidate for transcatheter therapy, PCI
Exclusion Criteria:
Subject will be excluded from participation in the investigation if he/she:
1. is currently enrolled in another clinical investigation
2. is unable to tolerate or comply with required post-surgical medications or imaging
(e.g., anticoagulation regimen; or known allergy to contrast agent)
3. is or may be pregnant or is lactating, or plans to become pregnant in the next 12
months
4. history of a hypercoagulable state
5. has had an acute MI within the last 21 days
6. has had a previous CABG
7. requires emergency surgery
8. has a left ventricular ejection fraction (LVEF) less than 35 %
9. has a target vessel stenosis of less than 75%
10. has a transmural infarct of the target artery territory
11. has a serum creatinine greater than 1.5 mg/dL
12. is having concomitant -surgery of any kind
13. has had previous saphenectomy (See inclusion)
14. has saphenous vein sizes incompatible with treatment range (i.e., <3.5 mm or >5 mm
inner diameter)
15. limb Ischemia or non-healing ulcer
16. has moderate to severe COPD defined as FEV 1 of less than 1 liter
17. has had a CVA in last 90 days
18. has diffuse disease in target vessel with an inadequate anastomotic touchdown site
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Intervention(s)
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Device: Angioshield
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Primary Outcome(s)
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Safety-reported MACE
[Time Frame: 30 days]
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Secondary Outcome(s)
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Safety, (MACE) will be assessed by recording and reporting of adverse events at the 30, 90, and 365 day follow-up visits.
[Time Frame: 90 and 365 days]
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Patency: Graft patency (via serial CT angiograms) will be measured at the 30, 90, and 365 day follow-up visits.
[Time Frame: 30, 90 ,and 365 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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