At a glance
ClinicalIndex Comparison RecordN/ACompleted· 128 enrolled
Drug / intervention
Renal Denervation (Symplicity Spyral™)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A clinical study evaluating Renal Denervation (Symplicity Spyral™) for Hypertension and 2 related conditions. Completed, enrolled 128 participants across 8 sites in 4 countries.
Detailed Summary
The objective of this single arm interventional study is to determine if renal denervation performed in the distal main and first order branch renal arteries is as effective in reducing blood pressure as the procedural approach used in the SPYRAL HTN-OFF MED clinical study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension, Vascular Diseases, Cardiovascular Diseases
CountriesGermany, Greece, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedMar 2020
Enrollment StartJun 2020
Primary CompletionDec 2022
TodayJul 2026
First PostedMar 17, 2020
Enrollment StartJun 12, 2020
Primary CompletionDec 22, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.3 years ago
Interventions
Renal Denervation (Symplicity Spyral™)device
Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.