The Optiflow Patency and Maturation Study

NCT01921933 | Completed DMC

• 1 other identifier: BCS_TP1070
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End-stage Kidney Disease; End-stage Renal Disease

Keywords

End-stage renal disease; ESRD; AVF; Fistulas

Outcome Measures

Primary Outcomes (2)

• Fistula Maturation

  The primary performance endpoint is the maturation percentage rate at 90 days. Maturation is defined as an access site intended for dialysis needle cannulation which achieves a diameter of greater or equal to 4 mm and blood flow greater or equal to 500 mL/min as measured via duplex ultrasound.

  90 days

• Serious Adverse Events Associated with Arteriovenous Fistula Creation

  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. All patients will be followed for safety for the duration of the study.

  90 days

Secondary Outcomes (6)

• Technical success

  1 day

• Assisted Maturation

  90 days

• Unassisted Maturation

  90 days

• Assisted Patency

  90 days

• Unassisted Patency

  90 days

Other Outcomes (7)

• Time to first cannulation

  Up to 90 days

• Ultrasound flow

  90 days

• Time To Access Site Abandonment

  Up to 90 days

Study Arms (1)

Optiflow

EXPERIMENTAL

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.

Device: Optiflow

Interventions

Optiflow DEVICE

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.

Also known as: Optiflow Anastomotic Connector

Optiflow

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female (verified with a urine/blood pregnancy test, for women of reproductive age).
• Life expectancy of at least one year, per the investigator's opinion.
• Diagnosed with ESRD or chronic kidney disease requiring dialysis.
• Planned upper extremity autogenous arteriovenous fistula.
• Planned anastomosis is an end of vein to side of artery configuration.
• AVF target artery and vein inner diameters are greater or equal to 3.0 mm and less than or equal to 7.0 mm as determined by pre-operative ultrasound and confirmed intra-operatively.
• Patient is available and willing to return for follow-up visits during the duration of the study.

You may not qualify if:

• Patient, or their legal representative, is willing and able to provide informed consent.
• Known bleeding diathesis or coagulation disorder.
• Documented or suspected central venous stenosis.
• Uncontrolled hypotension with systolic blood pressures \< 100 mg Hg at the time of screening.
• Peripheral white blood cell count \< 1.5 K/mm3 or platelet count \< 75,000 cells/mm3.
• Body Mass Index (BMI) \> 42.
• Transposition of the access vein is anticipated within the 90 day follow-up interval.
• Receiving anticoagulant therapy for non-cardiac indications.
• Evidence or history of an active or suspected infection within one month of screening.
• Scheduled kidney transplant within six months of enrollment.
• History of ≥ 2 AVF and/or synthetic access graft failures.
• History of steal syndrome from a previous hemodialysis vascular access which required intervention or abandonment.
• Current participation in another clinical trial (excluding retrospective studies or studies not requiring a consent form).
• Anticipated surgery requiring general anesthesia during the course of follow-up.
• A history of substance abuse.

Sponsors & Collaborators

• Bioconnect Systems, Inc: lead

Study Sites (1)

University of Cincinnati - Division of Nephrology

Cincinnati, Ohio, 45267-0585, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 14, 2013
• Study Start: February 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

US (1)