Post-market Clinical Study to Confirm Safety and Performance of PuraStat® Absorbable Haemostatic Material for the Management of Bleeding in Vascular Surgery.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Patients who have been previously treated with PuraStat®
Subject who is able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained
Subject, who, in the opinion of the Clinical Investigator, is able to understand this clinical study, cooperate with the study procedures and is willing to return for the required post-treatment follow-up
Main exclusion criteria:
Presence or sequelae of coagulation disorder
Known allergy or hypersensitivity to any component of PuraStat®
Concurrent participation in another clinical trial with a medical device or a medicinal product
Pregnant or interested in becoming pregnant during the duration of the study, or breast feeding