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The Boston Scientific ACCESS Trial

2014-08-27 03:47:22 | BioPortfolio

Summary

The Boston Scientific ACCESS trial seeks to study the safety and to evaluate the success of the Fusion™ Vascular Access Graft for patients in need of early vascular access for hemodialysis.

Description

The Boston Scientific ACCESS trial seeks to study the safety and to evaluate the success of the Fusion™ Vascular Access Graft for patients in need of early vascular access for hemodialysis. The primary objective is to demonstrate that secondary patency at 6 months for the Fusion™ Vascular Access Graft is not less than an objective performance criterion (OPC) minus a clinically relevant margin (δ). The OPC represents secondary patency at 6 months for the standard of care access grafts.

The secondary safety endpoint is the occurrence of CEC-adjudicated device or procedure related adverse events through 24 months post implant procedure, or through discharge for patients with unsuccessful device implantation. Secondary efficacy endpoints include:primary patency; primary assisted patency; ability to revise a failed graft; early access capability; time to hemostasis.

Subjects will undergo a thorough medical assessment and physical examination pre-procedure and will be assessed peri-procedure. Enrolled subjects with a device implanted will be evaluated at 1, 6, 12, 18 and 24 months post implant procedure.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Renal Disease

Intervention

vascular access graft implantation

Location

Long Beach VA Medical Center
Long Beach
California
United States
90822

Status

Active, not recruiting

Source

Maquet Cardiovascular

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:47:22-0400

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PubMed Articles [23205 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

Obstruction of flow in biological or prosthetic vascular grafts.

An immunological attack mounted by a graft against the host because of tissue incompatibility when immunologically competent cells are transplanted to an immunologically incompetent host; the resulting clinical picture is that of GRAFT VS HOST DISEASE.

The clinical entity characterized by anorexia, diarrhea, loss of hair, leukopenia, thrombocytopenia, growth retardation, and eventual death brought about by the GRAFT VS HOST REACTION.

The immune responses of a host to a graft. A specific response is GRAFT REJECTION.

Devices to be inserted into veins or arteries for the purpose of carrying fluids into or from a peripheral or central vascular location. They may include component parts such as catheters, ports, reservoirs, and valves. They may be left in place temporarily for therapeutic or diagnostic purposes.

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