The Fibrin Pad Cardiovascular Study
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/14/2018 |
| Start Date: | August 1, 2012 |
| End Date: | September 3, 2013 |
A Randomized, Controlled, Comparative Phase II Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery
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.
EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture
line bleeding in cardiovascular surgery.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
5
sites
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