The Optiflow Patency and Maturation Study

End-stage Renal Disease Clinical Trial

— OPEN  

Official title:

The "OPEN" Study Optiflow PatEncy and MaturatioN

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921933
• Other study ID #: BCS_TP1070
• Status: Completed
• Phase: N/A
• First received: August 9, 2013
• Last updated: January 11, 2016
• Start date: February 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Bioconnect Systems, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-stage Kidney Disease
• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	University of Cincinnati - Division of Nephrology	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Bioconnect Systems, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to first cannulation	Elapsed time to first use of access site.	Up to 90 days	No
Other	Ultrasound flow	Flow rate of blood through outflow vein	90 days	No
Other	Time To Access Site Abandonment	Elapsed time to abandonment of the access site.	Up to 90 days	No
Other	Access Site Related Adverse Events	The number of access related adverse events per subject	90 days	Yes
Other	Number of Access Site Related Hospitalizations	The number of access site related hospitalizations per subject.	90 days	Yes
Other	Catheter Utilization	Total number of days a catheter was used before access site maturation per subject.	90 days	No
Other	Total Adverse Events	Total number of adverse events	90 days	Yes
Primary	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	No
Primary	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	Yes
Secondary	Technical success	Technical success rate: An access site that demonstrates physical exam patency through hospital discharge.	1 day	No
Secondary	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.	90 days	No
Secondary	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.	90 days	No
Secondary	Assisted Patency	Assisted patency rate: An access site which is patent after intervening manipulations (surgical or endovascular) intended to promote or reestablish patency.	90 days	No
Secondary	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.	90 days	No
Secondary	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.	90 days	No