SPYRAL-DYSTAL
Research type
Research Study
Full title
Global Clinical Study of Renal Denervation in the distal main and first order branch renal arteries using the Symplicity Spyral multi-electrode renal denervation system (SPYRAL DYSTAL)
IRAS ID
277219
Contact name
Andrew Sharp
Contact email
Sponsor organisation
Medtronic Bakken Research Center
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 2 months, 30 days
Research summary
Research Summary
The purpose of this study is to evaluate whether we can reduce the complexity of the renal denervation procedure by treating certain parts of your renal arteries. We will then compare the results of this adapted technique to a prior trial that we have already completed, called the SPYRAL HTN-OFF MED study. In the SPYRAL HTN-OFF MED study, patients had an average of 44 ablations per patient. In this study a comparison was done between two patient groups, one where patients underwent the renal denervation procedure and second where they didn’t. It showed that patients who received the renal denervation procedure, on average, had a decrease in sitting blood pressure (office blood pressure) during hospital visits and also a drop in 24-hour blood pressure measured during a normal day of activity. Additionally, there were no major complications in both groups throughout the 3 months.
Summary of results
High blood pressure is a global health problem. Previous research has shown that renal denervation treatment with the Symplicity Spyral(tm) renal denervation system (Medtronic) is effective in lowering blood pressure in subjects with high blood pressure without using medication. The purpose of this study is to determine if renal denervation treatment in very specific areas of the renal arteries (blood vessels from the kidneys) and its branches, produces similar results to those demonstrated in previous research.
There were 128 subjects enrolled to treat 56 in the SPYRAL DYSTAL study. These 56 subjects were treated in 9 hospitals located in EU and USA. Results in these subjects were compared to the Renal Denervation Group of the SPYRAL HTN-OFF MED Pivotal study.
There were no reported deaths in this study and the incidence of Major Adverse Events occurring through 1-month was 3.6% (2/56) with no additional subjects experiencing endpoint events through 12-months. Renal function was maintained to 12 months.
The SPYRAL DYSTAL procedural approach significantly reduced the procedure time, denervation time, and amount of contrast used per subject compared to SPYRAL HTN-OFF MED Pivotal study.
The SPYRAL DYSTAL study demonstrated that renal denervation when performed in the distal main and first order branch renal arteries was as safe and effective in reducing blood pressure up to 12 months as the procedural approach used in the SPYRAL HTN-OFF MED Pivotal study.
REC name
Wales REC 1
REC reference
20/WA/0141
Date of REC Opinion
7 Aug 2020
REC opinion
Further Information Favourable Opinion