Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access
NCT ID: NCT01173718
Last Updated: 2013-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
138 participants
INTERVENTIONAL
2010-07-31
2013-02-28
Brief Summary
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\>\> A total of 138 Subjects will be enrolled. Once the study procedure has been successfully completed, cannulation may occur at any time at the Investigator's discretion. \>
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\>\> Subjects will be selected from up to 20 Investigational Sites.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GORE® ACUSEAL Vascular Graft
GORE® ACUSEAL Vascular Graft
Surgical implantation of the GORE® ACUSEAL Vascular Graft for Hemodialysis per the Investigator's standard of practice.
Interventions
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GORE® ACUSEAL Vascular Graft
Surgical implantation of the GORE® ACUSEAL Vascular Graft for Hemodialysis per the Investigator's standard of practice.
Eligibility Criteria
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Inclusion Criteria
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2. Patient is currently on hemodialysis or ready to begin hemodialysis within 30 days following placement of study device. \> \>\>
3. The patient must be able to have the vascular access graft placed in an upper extremity. \>
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4. The patient is 18 years of age or older. \>
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5. The patient has a reasonable expectation of remaining on hemodialysis for 12 months. \>
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6. The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements. \> \>\>
7. The patient or his/her legal guardian is willing to provide informed consent. \>
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Exclusion Criteria
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1. The patient has a documented and unsuccessfully treated ipsilateral central venous stenosis via imaging technique.\>
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2. The patient currently has a known or suspected systemic infection.\>
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3. The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.\>
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4. The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to heparin. \>
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5. The patient is being considered for a live (living donor either related or unrelated to patient) donor kidney transplant.\>
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6. The patient is enrolled in another investigational study.\>
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7. The patient has co-morbid conditions that may limit their ability to comply with study and follow-up requirements.\>
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8. Study device is intended to be used temporarily.\>
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9. The patient has had \>2 previous arteriovenous accesses in treatment arm.\>
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10. Patient is taking Aggrenox®.\>
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11. The patient is in need of, or is scheduled for a different vascular surgical procedure within 30 days of the study procedure.\>
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12. The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone(\>10 mg), cyclosporine, tacrolimus or cyclophosphamide.\>
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13. The patient has a known hypercoagulable or bleeding disorder or requires treatment with warfarin or heparin.\>
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14. Life expectancy is less than 12 months.\>
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15. The patient is pregnant.\>
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16. The patient is a poor compliance risk (i.e. history of IV or oral drug abuse).
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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Marc Glickman, MD
Role: PRINCIPAL_INVESTIGATOR
Sentara Vascular Specialists
References
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Glickman MH, Burgess J, Cull D, Roy-Chaudhury P, Schanzer H. Prospective multicenter study with a 1-year analysis of a new vascular graft used for early cannulation in patients undergoing hemodialysis. J Vasc Surg. 2015 Aug;62(2):434-41. doi: 10.1016/j.jvs.2015.03.020. Epub 2015 May 4.
Other Identifiers
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AVG 08-06
Identifier Type: -
Identifier Source: org_study_id
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