The Fibrin Pad Cardiovascular Study

Completed · Phase 2

Conditions studied: Cardiovascular Disease

In brief

This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.

Key facts

Study ID

NCT01681030

Run by

Ethicon, Inc.

People needed

42

Starts

2012-08-01

Expected to finish

2013-09-03

Last updated by the study team

2018-06-12

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 must be willing to participate in the study and provide written informed consent.

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 30 day follow up period after surgery.
• Female subjects who are pregnant or nursing.

Where it is running

• Clinical Investigation Site #5 — Indianapolis, Indiana, United States
• Clinical Investigation Site #6 — Kansas City, Missouri, United States
• Clinical Investigation Site #4 — Camden, New Jersey, United States
• Clinical Investigation Site #1 — Paterson, New Jersey, United States
• Clinical Investigation Site #3 — New York, New York, United States
• Clinical Investigation Site #2 — New York, New York, United States

Full record on ClinicalTrials.gov

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