Phase
Condition
Claudication
Atherosclerosis
Cardiovascular Disease
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Subject must meet all of the following criteria to be eligible for treatment in the Study:
The subject must be equal or greater than 18 years old.
The subject must be scheduled for the surgical placement of a synthetic (i.e.,PTFE/Dacron) vascular graft or patch for large vessel repair/arterialreconstruction/hemodialysis access/arteriotomy.
The subject has no child bearing potential or has a negative serum or urine pregnancytest within 7 days of the index procedure.
The subject is willing and able to be contacted for the follow up visits at 6 weeks (± 7 days) and 3 months (± 7 days).
The subject or guardian must provide written informed consent using a form that isreviewed and approved by the IRB.
Exclusion
Exclusion Criteria: Subjects will be excluded from the Study if any of the following criteria are met:
The subject has a known hypersensitivity or contraindication to heparin, bovine orseafood products.
The subject has a history of bleeding diathesis or coagulopathy, or will refuse bloodtransfusions.
The subject is currently enrolled in this, or another investigational device or drugtrial (IDE or IND) that has not completed the required follow-up period. Note:Extended follow-up trials for products that were investigational but are currentlycommercially available are not considered investigational trials.
Study Design
Study Description
Connect with a study center
Greenville Memorial Hospital
Greenville, South Carolina 29615
United StatesSite Not Available
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