The Fibrin Pad CV Phase III Study

Completed · Phase 3

Conditions studied: Cardiovascular Disease

In brief

The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.

Key facts

Study ID

NCT02040428

Run by

Ethicon, Inc.

People needed

156

Starts

2014-01-01

Expected to finish

2015-09-01

Last updated by the study team

2017-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass. Subjects in Japan between ≥18 and <20 years of age will require consent by the subject's legal representative
• Subjects must be willing to participate in the study and provide written informed consent.
• Presence of an appropriate Target Bleeding Site (TBS) along the anastomotic suture line, involving a synthetic aortic graft, as identified intra-operatively by the investigator;

You may not qualify if…

• Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
• Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 60 day follow up period after surgery.
• Female subjects who are pregnant or nursing.
• TBS is from a large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ Fibrin Sealant Patch to blood flow and/or pressure during absorption of the product;
• TBS with major arterial bleeding requiring suture or mechanical ligation;
• TBS involves an expanded polytetrafluoroethylene (ePTFE) graft
• TBS within an actively infected field;
• Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
• Subjects with any intra-operative findings identified by the investigator that may preclude conduct of the study procedure;

Where it is running

• Clinical Investigation Site #15 — Atlanta, Georgia, United States
• Clinical Investigation Site #14 — Indianapolis, Indiana, United States
• Clinical Investigation Site #16 — Baltimore, Maryland, United States
• Clinical Investigation Site #21 — Bethesda, Maryland, United States
• Clinical Investigation Site #17 — St Louis, Missouri, United States
• Clinical Investigation Site #10 — Paterson, New Jersey, United States
• Clinical Investigation Site #12 — New York, New York, United States
• Clinical Investigation Site #20 — Philadelphia, Pennsylvania, United States
• Clinical Investigation Site #18 — Houston, Texas, United States
• Clinical Investigation Site #72 — Camperdown, New South Wales, Australia
• Clinical Investigation Site #73 — Sydney, New South Wales, Australia
• Clinical Investigation Site #71 — Brisbane, Queensland, Australia
• Clinical Investigation Site #74 — Bedford Park, South Australia, Australia
• Clinical Investigation Site #70 — Melbourne, Victoria, Australia
• Clinical Investigation Site #40 — Ghent, Belgium
• Clinical Investigation Site #82 — Kanagawa, Isehara-shi, Japan
• Clinical Investigation Site #81 — Saitama, Saitama-shi, Japan
• Clinical Investigation Site #80 — Osaka, Suita-shi, Japan
• Clinical Investigation Site #33 — Bristol, England, United Kingdom
• Clinical Investigation Site #35 — Cottingham, England, United Kingdom
• Clinical Investigation Site #34 — Manchester, England, United Kingdom
• Clinical Investigation Site #32 — Aberdeen, Scotland, United Kingdom
• Clinical Investigation Site #31 — Clydebank, Scotland, United Kingdom
• Clinical Investigation Site #30 — Edinburgh, Scotland, United Kingdom

Full record on ClinicalTrials.gov

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