Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Angiotech Pharmaceuticals
The primary objective of this study is to determine long term safety of the Lifespan® ePTFE Vascular Graft and Vascular Wrap(TM) Paclitaxel-Eluting Mesh in comparison to the Lifespan® graft alone.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
have been randomized in protocol 012-VWAV06;
have signed and dated an IRB-approved written informed consent to participate in 012-VWAV06 as well as this study;
be willing to comply with all aspects of the evaluation schedule over a period of 60 months post device insertion;
allow representatives of the sponsor, designated Clinical Research Organization (CRO), Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records.
You may not be if
Subjects who withdrew or were withdrawn from study 012-VWAV06.
