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The Optiflow Patency and Maturation Study (OPEN)

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ClinicalTrials.gov Identifier: NCT01921933
Recruitment Status : Completed
First Posted : August 14, 2013
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):
Bioconnect Systems, Inc

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.

Condition or disease Intervention/treatment Phase
End-stage Kidney Disease End-stage Renal Disease Device: Optiflow Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The "OPEN" Study Optiflow PatEncy and MaturatioN
Study Start Date : February 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.
Other Name: Optiflow Anastomotic Connector




Primary Outcome Measures :
  1. Fistula Maturation [ Time Frame: 90 days ]
    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.

  2. Serious Adverse Events Associated with Arteriovenous Fistula Creation [ Time Frame: 90 days ]
    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 :
  1. Technical success [ Time Frame: 1 day ]
    Technical success rate: An access site that demonstrates physical exam patency through hospital discharge.

  2. Assisted Maturation [ Time Frame: 90 days ]
    Assisted maturation rate: An access site which achieves or maintains maturation following intervening manipulations (surgical or endovascular) designed to promote or reestablish maturation.

  3. Unassisted Maturation [ Time Frame: 90 days ]
    Unassisted fistula maturation rate: An access site that achieves and maintains maturation without any surgical or endovascular intervention designed to promote or reestablish Maturation.

  4. Assisted Patency [ Time Frame: 90 days ]
    Assisted patency rate: An access site which is patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency.

  5. Unassisted Patency [ Time Frame: 90 days ]
    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.

  6. Intervention Rate [ Time Frame: 90 days ]
    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.


Other Outcome Measures:
  1. Time to first cannulation [ Time Frame: Up to 90 days ]
    Elapsed time to first use of access site.

  2. Ultrasound flow [ Time Frame: 90 days ]
    Flow rate of blood through outflow vein

  3. Time To Access Site Abandonment [ Time Frame: Up to 90 days ]
    Elapsed time to abandonment of the access site.

  4. Access Site Related Adverse Events [ Time Frame: 90 days ]
    The number of access related adverse events per subject

  5. Number of Access Site Related Hospitalizations [ Time Frame: 90 days ]
    The number of access site related hospitalizations per subject.

  6. Catheter Utilization [ Time Frame: 90 days ]
    Total number of days a catheter was used before access site maturation per subject.

  7. Total Adverse Events [ Time Frame: 90 days ]
    Total number of adverse events



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921933


Locations
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United States, Ohio
University of Cincinnati - Division of Nephrology
Cincinnati, Ohio, United States, 45267-0585
Sponsors and Collaborators
Bioconnect Systems, Inc

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Responsible Party: Bioconnect Systems, Inc
ClinicalTrials.gov Identifier: NCT01921933     History of Changes
Other Study ID Numbers: BCS_TP1070
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

Keywords provided by Bioconnect Systems, Inc:
End-stage renal disease
ESRD
AVF
Fistulas

Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency