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The Angioshield Study Feasibility II

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Angioshield
Sponsored by
Neograft Technologies, Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Santariskiu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Right Region

Left Region

Arm Description

Angioshield will be applied to provide Mechanical Support for Vein Grafts Used in CABG in the right region of the heart

Angioshield will be applied to provide Mechanical Support for Vein Grafts Used in CABG in the left region of the heart

Outcomes

Primary Outcome Measures

Safety-reported MACE
The primary endpoint, 30 day safety, (MACE) will be assessed by recording and reporting of adverse events during surgery and throughout the investigation until the 30-day follow-up visit

Secondary Outcome Measures

Safety, (MACE) will be assessed by recording and reporting of adverse events at the 30, 90, and 365 day follow-up visits.
Patency: Graft patency (via serial CT angiograms) will be measured at the 30, 90, and 365 day follow-up visits.

Full Information

First Posted
September 2, 2015
Last Updated
May 24, 2018
Sponsor
Neograft Technologies, Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02543047
Brief Title
The Angioshield Study Feasibility II
Official Title
THE ANGIOSHIELD STUDY:Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neograft Technologies, Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery.
Detailed Description
The study is designed to investigate the feasibility of using an applied support (Angioshield) to a saphenous vein to be used in Coronary Artery Bypass Surgery. It is a feasibility to determine safety prior to launching a larger pivotal study. The primary endpoint, 30-day safety, will be assessed by recording and reporting of adverse events during surgery and throughout the investigation until the 30-day follow-up visit. The secondary endpoints, long term safety and patency, will be assessed by recording and reporting of adverse events and graft patency (via serial CT angiograms) at the 30, 90, and 365 day follow-up visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Right Region
Arm Type
Active Comparator
Arm Description
Angioshield will be applied to provide Mechanical Support for Vein Grafts Used in CABG in the right region of the heart
Arm Title
Left Region
Arm Type
Active Comparator
Arm Description
Angioshield will be applied to provide Mechanical Support for Vein Grafts Used in CABG in the left region of the heart
Intervention Type
Device
Intervention Name(s)
Angioshield
Intervention Description
Angioshield is applied to vein graft to provide Mechanical Support for Vein Grafts Used in CABG Surgery
Primary Outcome Measure Information:
Title
Safety-reported MACE
Description
The primary endpoint, 30 day safety, (MACE) will be assessed by recording and reporting of adverse events during surgery and throughout the investigation until the 30-day follow-up visit
Time Frame
30 days
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject will be eligible for inclusion in the investigation if he/she: is between the ages of 18 and 80 years of age, inclusive 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 is able to give their informed written consent is willing and able to complete all follow-up visits and procedures is to be treated via a medial sternotomy with cardio-pulmonary bypass during surgery has adequate saphenous veins Is a candidate for transcatheter therapy, PCI Exclusion Criteria: Subject will be excluded from participation in the investigation if he/she: is currently enrolled in another clinical investigation is unable to tolerate or comply with required post-surgical medications or imaging (e.g., anticoagulation regimen; or known allergy to contrast agent) is or may be pregnant or is lactating, or plans to become pregnant in the next 12 months history of a hypercoagulable state has had an acute MI within the last 21 days has had a previous CABG requires emergency surgery has a left ventricular ejection fraction (LVEF) less than 35 % has a target vessel stenosis of less than 75% has a transmural infarct of the target artery territory has a serum creatinine greater than 1.5 mg/dL is having concomitant -surgery of any kind has had previous saphenectomy (See inclusion) has saphenous vein sizes incompatible with treatment range (i.e., <3.5 mm or >5 mm inner diameter) limb Ischemia or non-healing ulcer has moderate to severe COPD defined as FEV 1 of less than 1 liter has had a CVA in last 90 days has diffuse disease in target vessel with an inadequate anastomotic touchdown site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gintaras Kalinauskas, MD
Organizational Affiliation
Santariskiu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santariskiu University Hospital
City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania

12. IPD Sharing Statement

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The Angioshield Study Feasibility II

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