N/A N=128 Treatment

SPYRAL DYSTAL Renal Denervation Global Clinical Study

Hypertension · Vascular Diseases · Cardiovascular Diseases

Bottom Line

View on ClinicalTrials.gov: NCT04311086 ↗

Enrolled (actual)

128

Serious AEs

12.5%

Results posted

Apr 2024

Primary outcome: Primary: Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) — -16.6 mmHg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Renal Denervation (Symplicity Spyral™) (Device)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Medtronic Vascular
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)	-1.4	—
SECONDARY Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)	-1.4	—
SECONDARY Change in Office Systolic Blood Pressure (SBP)	-20.3	—
SECONDARY Change in Office Systolic Blood Pressure (SBP)	-20.3	—
SECONDARY Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)	-11.2	—
SECONDARY Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)	-11.2	—
SECONDARY Change in Office Diastolic Blood Pressure (DBP)	-9.8	—
SECONDARY Change in Office Diastolic Blood Pressure (DBP)	-9.8	—
SECONDARY Incidence of Achieving Target Office Systolic Blood Pressure (SBP)	27	—
SECONDARY Incidence of Achieving Target Office Systolic Blood Pressure (SBP)	27	—
SECONDARY Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events	0; 0; 2; 2; 0; 0	—
SECONDARY Incidence of Myocardial Infarction	—	—
SECONDARY Incidence of Stroke	—	—
SECONDARY Incidence of Renal Artery Re-intervention	—	—
SECONDARY Incidence of Major Bleeding According to TIMI Definition	—	—
SECONDARY Incidence of Increase in Serum Creatinine >50%	—	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04311086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.