18 Clinical Trials for Various Conditions
The objective of this post-market clinical follow-up study is to evaluate the clinical outcomes of patients receiving PhotoFix as a patch within a vascular repair or reconstruction procedure.
Complications of hemodialysis access are the most frequent single reason for hospitalization among patients with End Stage Renal Disease (ESRD). Uremia, and particularly uremia in patients with diabetes, is a state of increased oxidative stress. The central hypothesis to be tested by this project is that oxidative stress is a major (and modifiable) trigger for vascular access complications. We hope to slow or reduce rates of stenosis, thrombosis and access complications by giving Vitamin E supplementation to patients being treated by hemodialysis.
The goal of this observational study is to increase the understanding of the safety and performance of Merit Medical's HeRO Graft System (HeRO) and Super HeRO Adaptor and Support Seal System (Super HeRO) devices. This study includes adults that are being treated with one of these devices as part of their regular medical care for maintaining long-term dialysis access when all other dialysis access options have failed. If participants in the study are not seen for a standard of care clinic visit during the 4 visit timepoints over 2 years, the participant will be followed by phone to check their current health and dialysis status.
This is a prospective, randomized, multi-center clinical trial for chronic kidney disease (CKD) patients referred for creation of a new arteriovenous fistula (AVF) in order to assess the safety and effectiveness of SelfWrap, a bioabsorbable perivascular wrap.
This is a prospective, multi-center, single-arm study designed to assess the safety and performance of the Pristine™ Long-Term Hemodialysis Catheter.
Vascular access is considered the Achilles heel of the dialysis patient. It constitutes the largest single cause of morbidity in the chronic hemodialysis population, accounting for over 25% of hospitalizations at an estimated cost in the US of at least one billion dollars annually. Currently, complication free survival of vascular access ranges between 30-50% a year and multiple investigative efforts in this area have been initiated and are directed at prolonging the functional life of vascular accesses. It is not well established whether intervention prior to overt malfunction or thrombosis of the vascular access could reduce these complications and thereby improve the functional longevity of the access. Moreover, once accesses at potential risk are identified, it is not well established which method of intervention, Surgery vs. Angioplasty vs. Expectant Management, is superior in terms of clinical and financial outcome. The proposed study aims to determine whether early intervention of a vascular access determined to be at risk of malfunction and thrombosis improves the long term outcome and, specifically, which means of intervention is preferred.
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. Primary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months. Participants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.
Hemodialysis represents a life line of patients with end stage renal disease, who are commonly maintained on hemodialysis through catheters. Prolonged exposure to these catheters eventually damages the walls of veins, which results in stenosis at the local site. This condition is called central venous stenosis (CVS) and affects number of patients on hemodialysis in the United States and can compromise the dialysis efficacy. The current diagnostic modality for CVS is venography, which has several limitations. This study proposes to examine intravenous ultrasound (IVUS) as a potentially superior modality, which will provide additional information.
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.
The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG. The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the creation of vascular access for dialysis.
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access.
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access
This will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly. The target sample size will include enrollment of 270 patients over a period of 5 years. The creation of an autologous arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of the study.
The aim of this phase 1 study is to determine the role of autologous adipose derived mesenchymal stem cells in the reduction of hemodialysis arteriovenous fistula failure when applied during the time of surgical creation.
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.
The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.
The Boston Scientific ACCESS trial seeks to study the safety and to evaluate the success of the Fusion™ Vascular Access Graft for patients in need of early vascular access for hemodialysis.
The objective of this study is to evaluate efficacy and safety outcomes following use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects undergoing surgical creation of an AV fistula for vascular access (index procedure).