SPYRAL DYSTAL Renal Denervation Global Clinical Study
Completed · Not applicable
Conditions studied: Hypertension, Vascular Diseases, Cardiovascular Diseases
In brief
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.
Key facts
- Study ID
- NCT04311086
- Run by
- Medtronic Vascular
- People needed
- 128
- Starts
- 2020-06-12
- Expected to finish
- 2022-12-22
- Last updated by the study team
- 2024-04-17
Who can join
Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg after being off medications.
- Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and < 170 mmHg.
- Individual is willing to discontinue current antihypertensive medications
You may not qualify if…
- Individual has estimated glomerular filtration rate (eGFR) of <45.
- Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
- Individual has one or more episodes of orthostatic hypotension.
- Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
- Individual has primary pulmonary hypertension.
- Individual is pregnant, nursing or planning to become pregnant.
- Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment.
- Individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time.
- Individual works night shifts.
Where it is running
- Stanford Hospital and Clinics — Stanford, California, United States
- Piedmont Heart Institute — Atlanta, Georgia, United States
- Baylor Heart & Vascular Hospital — Dallas, Texas, United States
- Universitaetsklinikum Erlangen — Erlangen, Germany
- Universitaetsklinikum des Saarlandes — Homburg, Germany
- Herzzentrum Leipzig — Leipzig, Germany
- Hippokration General Hospital of Athens — Athens, Greece
- University Hospital of Wales — Cardiff, United Kingdom
Full record on ClinicalTrials.gov
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