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Trial record 1 of 1 for:    A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
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Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03645681
Recruitment Status : Active, not recruiting
First Posted : August 24, 2018
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
InnAVasc Medical, Inc.

Brief Summary:
The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD). The InnAVasc AVG is implanted and used similar to other standard of care dialysis grafts currently on the market. However, the InnAVasc AVG has been uniquely designed to potentially allow for immediate needle access (same day as implant surgery as opposed to 2-4 weeks of waiting), to potentially reduce excessive bleeding from the graft after dialysis, and it may provide protection from improper or missed needle cannulation attempts.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Renal Dialysis Device: InnAVasc arteriovenous graft surgical implant Not Applicable

Detailed Description:

The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD). The InnAVasc AVG is implanted and used similar to other standard of care dialysis grafts currently on the market. However, the InnAVasc AVG has been uniquely designed to potentially allow for immediate needle access (same day as implant surgery as opposed to 2-4 weeks of waiting), to potentially reduce excessive bleeding from the graft after dialysis, and it may provide protection from improper or missed needle cannulation attempts.

This clinical investigation is a prospective, multi-center, single arm, non-randomized study. Participants with ESRD who require hemodialysis and are suitable for an AVG for hemodialysis access will be eligible for inclusion in the study. Suitable participants will be implanted with an InnAVasc AVG in the forearm or upper arm using standard vascular surgical techniques. The graft will be placed in a "straight" (soft "C") configuration in the upper arm, or looped configuration in the forearm (forearm loop) or upper arm (axillary loop). Twenty-six (26) participants will be enrolled to be implanted with the InnAVasc AVG from up to 7 investigational sites in the United States.

The primary effectiveness endpoint of secondary graft patency will be assessed at 6 months but the total study duration is 24 months. The primary safety endpoint will include characterization of dialysis graft adverse events over 6 months. It is hypothesized that the InnAVasc AVG will provide a secondary patency rate similar to the current standard of care dialysis access grafts on the market, but will have the potential to reduce needle cannulation-related adverse events and complications.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients will be implanted with an InnAVasc AVG in the forearm or upper arm using standard vascular surgical techniques. There are two model versions of the InnAVasc Graft. The looped model and the straight model. The graft will be placed in a "straight" (soft "C") configuration in the upper arm, or looped configuration in the forearm (forearm loop) or upper arm (axillary loop).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: InnAVasc AVG treatment
Patients will be surgically implanted with an InnAVasc AVG in the forearm or upper arm using standard vascular surgical techniques. The graft will be placed in a "straight" (soft "C") configuration in the upper arm, or looped configuration in the forearm (forearm loop) or upper arm (axillary loop).
Device: InnAVasc arteriovenous graft surgical implant
An InnAVasc AVG will be surgically implanted into the upper arm or forearm of enrolled participants




Primary Outcome Measures :
  1. Secondary patency of InnAVasc AVG [ Time Frame: at 6 months ]
    Secondary patency is defined as the time from placement of the AVG to abandonment, including surgical or endovascular interventions designed to reestablish AVG patency

  2. Incidence of adverse events of special interest related to InnAVasc AVG [ Time Frame: through 6 months ]
    1. Infection of the study device;
    2. Pseudoaneurysm formation at any point along the access circuit requiring surgical/endovascular intervention, including thrombin injection and compression (pseudoaneurysms that occur at sites of needle cannulation, but which are small enough to be observed without intervention, do not trigger this element of the AESI endpoint);
    3. Bleeding from the study graft requiring surgical or endovascular intervention or ≥2-unit blood transfusion;
    4. Hematoma from the study graft requiring surgical or endovascular intervention;
    5. Seroma from the study graft requiring surgical or endovascular intervention;
    6. Thrombosis of the study graft.


Secondary Outcome Measures :
  1. Functional patency of InnAVasc AVG [ Time Frame: 3, 6, 12, 18, and 24 months ]
    InnAVasc AVG patent and usable for hemodialysis as defined by: AV access that can be cannulated with two dialysis needles for at least 75% of dialysis sessions within a 4- week period to achieve the prescribed dialysis

  2. Time to successful cannulation of the InnAVasc AVG [ Time Frame: Over the first 2 months post implant ]
    Time from the index procedure to the first 2- needle dialysis session through the InnAVasc AVG

  3. Proportion achieving sustained use [ Time Frame: 6, 12, and 24 months ]
    Proportion achieving sustained use of 3 months, 6, months, 12 months, 18 months, and 24 months. Sustained use is a period of time in which the study graft is used for consecutive dialysis sessions without the requirement for alternative hemodialysis vascular access to allow for renal replacement therapy. A sustained use period can be achieved at any time throughout the study period of 24 months.


Other Outcome Measures:
  1. Primary patency rate of InnAVasc AVG [ Time Frame: 3, 6, 12, 18 and 24 months ]
    Time from placement to first thrombosis, or intervention to restore or maintain patency

  2. Assisted primary patency rate of InnAVasc AVG [ Time Frame: 3, 6, 12, 18 and 24 months ]
    Time from placement to first intervention to maintain patency

  3. Days of dialysis catheter in situ [ Time Frame: 3, 6, 12, 18 and 24 months ]
    Cumulative number of days an enrolled participant has a central venous catheter in place

  4. Incidence of individual adverse events [ Time Frame: 3, 6, 12, 18 and 24 months ]
    Frequency of all adverse events experience by each participant

  5. Change from baseline of patient reported outcomes measures / experience measures [ Time Frame: 3, 6, 12, 18 and 24 months ]
    Participants will complete a survey designed to assess issues around cannulation of dialysis access, technical issues, pain, anxiety.

  6. Health Economics derived from collected study data [ Time Frame: 3, 6, 12, 18 and 24 months ]
    1. Overall cost to create and maintain arteriovenous (AV) access
    2. Catheter related costs
    3. Cost of AV access related complications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with ESRD who are not, or who are no longer, candidates for creation of an autologous AV fistula and therefore need placement of an AV graft to start or maintain hemodialysis therapy;
  • Age 18 to 80 years old, inclusive;
  • Suitable anatomy for implantation of upper arm "straight" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow);
  • For patients NOT on Coumadin / warfarin, international normalized ratio (INR) ≤1.5;
  • Able and willing to give informed consent;
  • Anticipated life expectancy of at least 1 year.

Additional inclusion criteria on Day 0 (intraoperative):

  • Both vessels have been exposed and are deemed appropriate for implantation implantation (i.e. based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow and is safely clampable (i.e. artery has lack of significant calcification); and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction).

Exclusion Criteria:

  • History or evidence of severe cardiac disease (New York Heart Association [NYHA] Functional Class III or IV), myocardial infarction within 6 months prior to enrollment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina;
  • Diabetes with a hemoglobin A1c (HbA1c) > 10%
  • For upper arm straight configuration, antecubital fossa crease to axillary crease distance < 18 cm.
  • History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e. arterial inflow insufficient to support hemodialysis access);
  • Known or suspected central vein stenosis or obstruction on the side of planned graft implantation;
  • In the opinion of the investigator, baseline hypotension, or history of frequent hypotensive episodes during dialysis that puts the patient at increased risk of graft thrombosis;
  • In the opinion of the investigator, uncontrolled hypertension;
  • Baseline hemoglobin <8 g/dL;
  • Baseline platelet count <100,000 or >500,000 cells/mm3;
  • Documented history of stroke within 6 months prior to enrollment;
  • Treatment with any investigational drug or device within 30 days prior to enrollment;
  • Female patients who are pregnant, intending to become pregnant, nursing or intending to breastfeed during the study (pregnancy test may only be omitted, if patient is post-menopausal or has a documented history of hysterectomy);
  • History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin;
  • Immunodeficiency, including documented history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) or patients receiving immunosuppressive therapy for treatment of an acute inflammatory event or autoimmune flare. Chronic immunosuppressive therapy is acceptable;
  • Documented or suspected hypercoagulable state;
  • Bleeding diathesis, other than that associated with ESRD;
  • Documented history of heparin-induced thrombocytopenia (HIT);
  • Active local or systemic infection as documented from the medical history or bloodwork / blood culture data. If the infection resolves, the subject must be at least one-week post resolution of that infection before implantation;
  • Scheduled renal transplant within 6 months;
  • Any other condition which in the judgment of the investigator would preclude adequate evaluation

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): NCT03645681


Locations
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United States, California
California Institute of Renal Research
San Diego, California, United States, 92123
United States, Michigan
Michigan Vascular Center
Flint, Michigan, United States, 48507
United States, Mississippi
Greenwood Leflore Hospital
Greenwood, Mississippi, United States, 38930
United States, South Carolina
Dialysis Access Institute at the Regional Medical Center
Orangeburg, South Carolina, United States, 29118-1498
United States, Texas
Cardiothoracic and Vascular Surgeons
Austin, Texas, United States, 78756
Baylor Heart and Vascular Hospital
Dallas, Texas, United States, 75226
United States, Virginia
Inova Health Care Service
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
InnAVasc Medical, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Study Director: Shawn M Gage, PA-C InnAVasc Medical, Inc.

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Responsible Party: InnAVasc Medical, Inc.
ClinicalTrials.gov Identifier: NCT03645681    
Other Study ID Numbers: CSP-1001
2R44DK108488-02 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by InnAVasc Medical, Inc.:
Vascular Access
Hemodialysis Access
End Stage Renal Disease
Kidney Failure
Hemodialysis
Arteriovenous Graft
AVG
Cannulation
Quick Sealing dialysis graft
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases