IRB Study Number 21-427
Status Recruiting
Phase Phase 2
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
You may be eligible to take part in this research study if your doctor has told you that your dialysis access circuit has a blockage that is causing an issue with your dialysis sessions and you have been told you will need treatment and have already agreed to having a procedure that may involve an angioplasty (widening of the blood vessel by inflating a small balloon for a short time) and a stent or stent graft (a small mesh tube to support the inner wall of the blood vessel and keep it open). These are routine procedures to improve blood flow in your dialysis access circuit. This study is using a new type of stent graft and catheter to enable your doctor to deliver the stent into the blood vessel that requires treatment. Together they are called the “WRAPSODY Stent Graft System.” This is an investigational (experimental) device. It is not approved by the Food and Drug Administration (FDA).
Inclusion Criteria
Subject has clinical and/or hemodynamic evidence of a venous outflow obstruction or AV fistula or graft dysfunction.
Subject is male or female, with an age ≥ 18 years at date of enrollment.
Subject has a life expectancy ≥ 12 months.
Subject is undergoing chronic hemodialysis
Exclusion Criteria
Subject has any planned major surgical or endovascular procedures (including within the access circuit) within 30 days after the index procedure.
Subject has a known or suspected infection of the hemodialysis access site, systemic infection and/or sepsis.
Subject has a known history of bleeding or clotting disorders.
