The Angioshield Study Feasibility II

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543047
• Other study ID #: TP14-026
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: March 7, 2018

Study information

• Verified date: October 2017
• Source: Neograft Technologies, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 7, 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Angioshield
Angioshield is applied to vein graft to provide Mechanical Support for Vein Grafts Used in CABG Surgery

Locations

Country	Name	City	State
Lithuania	Santariskiu University Hospital	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Neograft Technologies, Incorporated

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Secondary	Safety, (MACE) will be assessed by recording and reporting of adverse events at the 30, 90, and 365 day follow-up visits.		90 and 365 days
Secondary	Patency: Graft patency (via serial CT angiograms) will be measured at the 30, 90, and 365 day follow-up visits.		30, 90 ,and 365 days