Peripheral vascular interventions are minimally invasive options for the treatment of patients with peripheral arterial disease (PAD). Unfortunately, the effects of this procedure are short-term and there remains a high rate (40-70%) of restenosis (re-narrowing of the arteries). The purpose of this research study is to determine if the use of the catheter for the delivery of the study drug called paclitaxel, will prevent re-narrowing of the blockage of an artery to be treated in the leg.
The purpose of this study is to collect measurements related to the body such as blood pressure, the amount of oxygen in the blood, and heart rhythm recordings. Findings from this study may be used to help design new device-based monitoring technologies in the future.
Continuous blood pressure readings will be obtained during standard of care heart catheterization procedures that include the use of an arterial blood pressure line. Continuous readings of oxygen saturation and ECG will also be obtained. Participants will consist of subjects aged ? 18 years who are scheduled to undergo a cath-lab (cath-lab, percutaneous coronary intervention or equivalent) procedure that includes the use of an arterial blood pressure line.
This is a clinical study looking at the effectiveness and safety of a new device call The Paradise System to use for renal denervation in patients who have mild to resistant hypertension. The study is divided into two groups, those on one to two anti hypertensive medications and those on three or more. For those only taking one or two medications, they will stop their current blood pressure medication while monitoring their blood pressure. Those who are taking 3 or more blood pressure medications will stop their current medication regime and be given one of two combination medications while monitoring their blood pressure. In each of the groups have the patients, if and when they continue to meet study inclusion criteria, will be randomized to undergo a renal denervation procedure using the new system vs no procedure. Their assignment will not be made known to them. All groups will be follow up to 3 years but for patients who did not initially have the procedure will be allowed to do so after one year. The goal of the renal denervation is to lower blood pressure by using ultrasound waves to heat and disable the nerves surrounding the blood vessels leading to the kidneys. It is believed these nerves may be too active in patients with high blood pressure.