BridgeMD
New treatment option for End Stage Kidney Disease (ESRD)
Official title STARgraft (10401) Pilot
ClinicalTrials.gov ID: NCT07555717
What this study is testing
- What it's testing
- This study is a single site, prospective, single arm evaluation of the safety and effectiveness of the Healionics STARgraft (10401) hemodialysis access graft. The study is enrolling patients with End Stage Renal Disease (ESRD) requiring hemodialysis via a prosthetic vascular graft.
- Time commitment: about 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 and older
You may be able to join if
- Adult patients, 18 years or older.
- Patient has given informed consent to participate in the trial.
- Stated willingness to comply with all trial procedures and availability for the duration of the trial.
- Able to effectively communicate with trial personnel.
- Indicated patient population (end stage renal disease).
You likely can't join if
- Unable or unlikely to comply with trial protocol and/or follow-up.
- Pregnancy.
- Previous history of Peritoneal Dialysis treatment within the last 2 months
- Central venous catheter located on same side as intended implant location.
- Clinical morbid obesity (BMI \> 40).
- Anatomical limitations, including issues discovered intraoperatively during vessel exposure.
See the full eligibility criteria
- Adult patients, 18 years or older.
- Patient has given informed consent to participate in the trial.
- Stated willingness to comply with all trial procedures and availability for the duration of the trial.
- Able to effectively communicate with trial personnel.
- Indicated patient population (end stage renal disease).
- Candidate for a new AV graft placed in the upper arm and judged to need dialysis within 2 months. Patient may have a failed access at a different anatomical location.
- Life expectancy judged to be at least 2 years with consideration of patient frailty.
- Axillary vein approximately 7 mm in diameter or greater.
- Brachial artery approximately 4 mm in diameter or greater.
- Acceptable cardiac risk level (cardiac output ≥ 3.5 l/min, pulmonary artery pressure ≤ 50 mmHg, and ejection fraction ≥ 40%).
- Systolic blood pressure equal to or greater than 120 mmHg.
- Absence of central venous stenosis downstream from implant site confirmed with ultrasound and/or venogram.
- Unable or unlikely to comply with trial protocol and/or follow-up.
- Pregnancy.
- Previous history of Peritoneal Dialysis treatment within the last 2 months
- Central venous catheter located on same side as intended implant location.
- Clinical morbid obesity (BMI \> 40).
- Anatomical limitations, including issues discovered intraoperatively during vessel exposure.
- Immunodeficiency syndrome.
- History of hypercoagulation or bleeding disorders.
- Elevated platelet count \> 1 million per microliter of blood.
- History of heparin-induced thrombocytopenia syndrome
- Medically confirmed stenosis or compromised valves in the veins downstream of the implant site.
- Inadequate arterial flow or pressure proximal to the implant site.
- Currently participating in another investigational drug or device trial which may clinically interfere with any endpoints of this trial.
- Fever greater than 38°C.
- Known allergic reaction to silicone, or untreatable allergy to imaging contrast materials.
- Confirmed or suspected bacterial, viral or parasitic infection within 8 weeks prior to graft implant, or ongoing symptoms.
- Uncontrolled or poorly controlled diabetes.
- History or evidence of severe cardiac disease.
- Any other condition which, in the judgment of the Investigator, would preclude adequate evaluation or impact patient safety or trial conduct.
The study team makes the final eligibility decision.
Where it's taking place
- Asunción, Paraguay
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 study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Asunción, Paraguay. 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.