The Angioshield Study Feasibility II

NCT02543047 | Completed DMC

• 1 other identifier: TP14-026
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Right Region

ACTIVE COMPARATOR

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

Device: Angioshield

Left Region

ACTIVE COMPARATOR

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

Device: Angioshield

Interventions

Angioshield DEVICE

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

Left Region; Right Region

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 saphenous vein sizes incompatible with treatment range (i.e., \<3.5 mm or \>5 mm inner diameter)
• limb Ischemia or non-healing ulcer

Sponsors & Collaborators

• Neograft Technologies, Incorporated: lead

Study Sites (1)

Santariskiu University Hospital

Vilnius, LT-08661, Lithuania

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Gintaras Kalinauskas, MD

  Santariskiu University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2015
• First Posted: September 7, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 7, 2018
• Last Updated: May 25, 2018

Record last verified: 2017-10

Locations

LI (1)