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The Optiflow Patency and Maturation Study (OPEN)

Primary Purpose

End-stage Kidney Disease, End-stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optiflow
Sponsored by
Bioconnect Systems, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Kidney Disease focused on measuring End-stage renal disease, ESRD, AVF, Fistulas

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • Patient is able and willing to follow a daily aspirin and/or other anticoagulation/antiplatelet regimen not including warfarin (see exclusion criteria).
  • Patient, or their legal representative, is willing and able to provide informed consent.

Exclusion Criteria:

  • 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.
  • Anticipated to be non-compliant with medical care or study requirements based on investigator judgment.
  • Need for immunosuppressive therapy at a dose greater than the equivalent of prednisone 10 mg per day.

Sites / Locations

  • University of Cincinnati - Division of Nephrology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Optiflow

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Technical success
Technical success rate: An access site that demonstrates physical exam patency through hospital discharge.
Assisted Maturation
Assisted maturation rate: An access site which achieves or maintains maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation.
Unassisted Maturation
Unassisted fistula maturation rate: An access site that achieves and maintains maturation without any surgical or endovascular intervention designed to promote or reestablish Maturation.
Assisted Patency
Assisted patency rate: An access site which is patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency.
Unassisted Patency
Unassisted patency rate: An access site that maintains patency without any surgical or endovascular intervention designed to maintain or reestablish blood flow in the access site.
Intervention Rate
Intervention rate: The number of occurrences that a subject's access site is surgically or endovascularly operated on to maintain or reestablish blood flow in the access site.

Full Information

First Posted
August 9, 2013
Last Updated
January 11, 2016
Sponsor
Bioconnect Systems, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01921933
Brief Title
The Optiflow Patency and Maturation Study
Acronym
OPEN
Official Title
The "OPEN" Study Optiflow PatEncy and MaturatioN
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioconnect Systems, Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Kidney Disease, End-stage Renal Disease
Keywords
End-stage renal disease, ESRD, AVF, Fistulas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optiflow
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Optiflow
Other Intervention Name(s)
Optiflow Anastomotic Connector
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fistula Maturation
Description
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.
Time Frame
90 days
Title
Serious Adverse Events Associated with Arteriovenous Fistula Creation
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Technical success
Description
Technical success rate: An access site that demonstrates physical exam patency through hospital discharge.
Time Frame
1 day
Title
Assisted Maturation
Description
Assisted maturation rate: An access site which achieves or maintains maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation.
Time Frame
90 days
Title
Unassisted Maturation
Description
Unassisted fistula maturation rate: An access site that achieves and maintains maturation without any surgical or endovascular intervention designed to promote or reestablish Maturation.
Time Frame
90 days
Title
Assisted Patency
Description
Assisted patency rate: An access site which is patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency.
Time Frame
90 days
Title
Unassisted Patency
Description
Unassisted patency rate: An access site that maintains patency without any surgical or endovascular intervention designed to maintain or reestablish blood flow in the access site.
Time Frame
90 days
Title
Intervention Rate
Description
Intervention rate: The number of occurrences that a subject's access site is surgically or endovascularly operated on to maintain or reestablish blood flow in the access site.
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Time to first cannulation
Description
Elapsed time to first use of access site.
Time Frame
Up to 90 days
Title
Ultrasound flow
Description
Flow rate of blood through outflow vein
Time Frame
90 days
Title
Time To Access Site Abandonment
Description
Elapsed time to abandonment of the access site.
Time Frame
Up to 90 days
Title
Access Site Related Adverse Events
Description
The number of access related adverse events per subject
Time Frame
90 days
Title
Number of Access Site Related Hospitalizations
Description
The number of access site related hospitalizations per subject.
Time Frame
90 days
Title
Catheter Utilization
Description
Total number of days a catheter was used before access site maturation per subject.
Time Frame
90 days
Title
Total Adverse Events
Description
Total number of adverse events
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Patient is able and willing to follow a daily aspirin and/or other anticoagulation/antiplatelet regimen not including warfarin (see exclusion criteria). Patient, or their legal representative, is willing and able to provide informed consent. Exclusion Criteria: 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. Anticipated to be non-compliant with medical care or study requirements based on investigator judgment. Need for immunosuppressive therapy at a dose greater than the equivalent of prednisone 10 mg per day.
Facility Information:
Facility Name
University of Cincinnati - Division of Nephrology
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States

12. IPD Sharing Statement

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The Optiflow Patency and Maturation Study

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