The kidneys are an important regulator of blood pressure. Previous research has shown that disrupting the nerves (denervate) of the kidney may successfully decrease blood pressure. In the past, one technique that was used to treat severe high blood pressure was a surgical procedure to cut these nerves. However, this surgery is no longer commonly performed. Another approach to disrupting these nerves is to use the Beta-Cath 3.5F system to deliver a small amount of radiation to the treatment zone. The Beta-Cath 3.5F System (Novoste) is currently approved in the United States to deliver ion dose therapy to re-narrowings that form in the coronary arteries in the heart. This trial is assessing the safety of treating patients with the Beta-Cath 3.5F System (Novoste) to denervate the nerves around the kidney to help control blood pressure in patients with uncontrolled hypertension. 1. Renal artery brachytherapy with beta-emitting source is safe. 2. Renal artery brachytherapy with beta-emitting source can reduce systolic/diastolic blood pressure via renal denervation mechanism within 6 months post treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
2
Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.
Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Safety-renal Artery Brachytherapy With Beta-emitting Source is Any Need for Renal Artery Intervention to Treat Renal Artery Injury Induced by the Catheter of Radiation Within 6 Months
The primary safety endpoint for renal artery brachytherapy with beta-emitting source is any need for renal artery intervention to treat renal artery injury induced by the catheter of radiation within 6 months
Time frame: up to 6 months post procedure
Efficacy- Renal Artery Brachytherapy With Beta-emitting Source is Decrease in Systolic and Diastolic Blood Pressure of ≥10 mmHg at Six Months Following the Procedure.
The primary efficacy endpoint for renal artery brachytherapy with beta-emitting source is decrease in systolic and diastolic blood pressure of ≥10 mmHg at six months following the procedure.
Time frame: up to 6 months post procedure
Angiographic
The angiographic endpoint is defined as late loss at 6 months by offline quantitative coronary angiography (QCA)
Time frame: up to 6 months post procedure
Effects on Blood Pressure
Short term effects of renal artery brachytherapy on blood pressure
Time frame: up to 6 months post procedure
Safety-renal Artery Dissection or Perforation Requiring Intervention, and Serious Groin Complications Specifically.
Acute procedural safety; renal artery dissection or perforation requiring intervention, and serious groin complications specifically.
Time frame: up to 24 months post procedure
eGFR or New Stenosis
Estimated glomerular filtration rate (eGFR) drop \>25% or new renal artery stenosis \> 60% confirmed by angiogram at six months following renal artery brachytherapy procedure.
Time frame: up to 6 months post procedure
Medication Changes
Any changes made in the patients' blood pressure medication regimen throughout the 24 month duration. Specifically, 1. Additions, changes and cessation of medications 2. Dosage changes throughout the follow up duration
Time frame: up to 24 months post procedure
Serious Adverse Events
Rate of any serious adverse events or device-related adverse events
Time frame: up to 24 months post procedure
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