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Tests treatment safety and results for End Stage Renal Disease (ESRD)
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
ClinicalTrials.gov ID: NCT04671771
What this study is testing
- What it's testing
- The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are: Primary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Pre-Operative Patients must meet the following criteria at screening in order to be scheduled for a procedure and potentially enrolled in the study:
- Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy;
- Age 18 to 90 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);
- Ability to continue or commence antiplatelet therapy post graft implant (anticoagulation medication is acceptable if the subject is required to take...
You likely can't join if
- Patients will be excluded from the study at screening if they exhibit any of the following exclusion criteria:
- History or evidence of severe cardiac disease (i.e., debilitating heart failure, or high risk of MI) in the opinion of the investigator which may...
- Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations);
- For upper arm straight configuration, an 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...
- Known or suspected central vein stenosis or obstruction on the side of planned graft implantation;
See the full eligibility criteria
Who can join
- Pre-Operative Patients must meet the following criteria at screening in order to be scheduled for a procedure and potentially enrolled in the study:
- Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy;
- Age 18 to 90 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);
- Ability to continue or commence antiplatelet therapy post graft implant (anticoagulation medication is acceptable if the subject is required to take an anticoagulant for a baseline medical condition);
- Able and willing to give informed consent;
- Anticipated life expectancy of at least 1 year. Intra-Operative Both vessels have been exposed and are deemed appropriate for implantation (i.e., based on the surgeon's opinion, artery is of adequate size, has adequate...
What rules you out
- Patients will be excluded from the study at screening if they exhibit any of the following exclusion criteria:
- History or evidence of severe cardiac disease (i.e., debilitating heart failure, or high risk of MI) in the opinion of the investigator which may preclude participation in and completion of the study;
- Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations);
- For upper arm straight configuration, an 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;
- Baseline hypotension or history of frequent hypotensive episodes during dialysis that, in the opinion of the investigator, puts the patient at increased risk of graft thrombosis;
- Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness);
- Baseline hemoglobin \<7 g/dL;
- Baseline platelet count \ 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...
- 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...
- Documented or suspected hypercoagulable condition;
- 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...
- Scheduled renal transplant within 6 months;
- Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and how well it works of the IG;
- Patient is unable or unwilling to complete all required follow-up assessments and questionnaires.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Augusta, Georgia, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Newark, New Jersey, United States
- New York, New York, United States
- The Bronx, New York, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Raleigh, North Carolina, United States
- Sayre, Pennsylvania, United States
- Greenville, South Carolina, United States
- Orangeburg, South Carolina, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Sarasota, Florida, United States; Tampa, Florida, United States; Augusta, Georgia, United States; Louisville, Kentucky, United States; Baltimore, Maryland, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.