NCT01921933

The Optiflow Patency and Maturation Study

The "OPEN" Study Optiflow PatEncy and MaturatioN

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Bioconnect Systems, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the performance and safety of the Optiflow Anastomotic Connector (Optiflow) when used to facilitate the creation of autogenous arteriovenous fistula (AVF) anastomoses.

Detailed description

The investigation is designed as a multi-center, prospective, single-arm, clinical study of the Optiflow performance and safety in a maximum of 180 subjects which includes one (1) roll-in subjects per investigator (maximum of 36 roll-in subjects). Subjects will be followed at 14 days post-procedure, 42 days post-procedure, and 90 days post-procedures. Results will be compared to a pre-established performance goal. Up to fifteen (15) investigational sites will participate in the investigational study. The primary performance endpoint is the overall maturation percentage rate at 90 days. Maturation is defined as an access site which achieves a diameter of greater or equal to 4 mm and blood flow greater or equal t0 500 mL/min as measured via duplex ultrasound. The primary safety endpoint is a composite endpoint of serious adverse events known to be associated with arteriovenous fistula anastomosis surgical procedures through 90 days.

Conditions

• End-stage Kidney Disease
• End-stage Renal Disease

Interventions

Type	Name	Description
DEVICE	Optiflow	The Optiflow device will be implanted in the upper extremity of Adult end-stage renal disease (ESRD) patients requiring creation of an upper extremity autogenous arteriovenous fistula for dialysis access.

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-10-01
• Completion: 2016-01-01
• First posted: 2013-08-14
• Last updated: 2016-01-12

Locations

1 site across 1 country: United States