A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the Relay PRO Thoracic Stent-Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

  • This trial is a prospective, multicenter, non-blinded, non-randomized study of the Relay PRO Thoracic Stent-Graft in subjects with Thoracic Aortic Aneurysms (TAAs) and Penetrating Atherosclerotic Ulcers (PAUs)
  • The purpose of this study is to investigate the safety and effectiveness of the Relay PRO Thoracic Stent-Grafts in subjects with aneurysms and PAUs within the descending thoracic aorta.

Post-Approval Study Of Transcarotid Artery Revascularization In Patients With Significant Carotid Artery Disease

Study Overview

  • The ROADSTER 2 Study is an open label, single arm, multi-center post-approval Study for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and who are eligible for treatment with a combination of the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid NPS

Treatment of Breast Fibroadenoma targeted tissue with High Intensity Focused Ultrasound (HIFU): A Pivotal Multi Center Prospective Study

The purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self-breast exams, or they may be found during a routine mammogram. Some are small (less than an inch in size), and others are quite large (the size of a lemon or larger).Several symptoms could be associated to the presence of fibroadenoma.

Prospective, non-randomized, open label clinical study to assess the feasibility of the Bioabsorbable pulmonary valved conduit in subjects undergoing Right Ventricular Outflow Tract (RVOT) reconstruction

This is a multi-center prospective, single-arm, non-randomized, open label study to assess feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations.

Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair (ReChord)

The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).

The LESS GERD Trial For Adults Living with Severe Reflux

Gastroesophageal reflux disease (GERD) is a chronic digestive disease that affects nearly 65 million people in the United States.1 It occurs when stomach acid or stomach contents flow back into your food pipe (esophagus). The backwash (reflux) irritates the lining of your esophagus and causes GERD.2 Frequent and troublesome symptoms may include one or more of the following: heartburn, regurgitation, sleep disruption, vocal impairment, and respiratory complications.

A Randomized Trial Comparing the ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent for Treatment of Superficial Femoral and/or Proximal Popliteal Arteries

This trial will be comparing the Eluvia stent with the Zilver PTX stent in patients with chronic, symptomatic atherosclerosis of the lower extremities. The primary objective of this trial is to evaluate the safety and effectiveness of the ELUVIA Drug-Eluting Vascular Stent System.

Randomized Study of Early Palliative Care Integrated With Standard Oncology Care Versus Standard Oncology Care Alone In Patients With Incurable Lung or Non- Colorectal Gastrointestinal Malignancies

To determine the efficacy of early integrated palliative care on patient reported quality of life at 12 weeks using the FACT in patients with newly diagnosed incurable lung or non-colorectal gastrointestinal cancer