Clinical trial NCT04311086: SPYRAL DYSTAL Renal Denervation Global Clinical Study
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Vascular Diseases
Cardiovascular Diseases
Keywords: Uncontrolled hypertension
Renal denervation
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2020-03-17
Enrollment: 128
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: From Baseline (SV2) to 12 months post-procedure
Secondary outcomes:
measure: Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: From Baseline (SV2) to 3 months post-procedure
measure: Change in Office Systolic Blood Pressure (SBP)
timeFrame: From Baseline (SV2) to 3 months post-procedure
measure: Change in Office Systolic Blood Pressure (SBP)
timeFrame: From Baseline (SV2) to 12 months post-procedure
measure: Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: From Baseline (SV2) to 3 months post-procedure
measure: Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
timeFrame: From Baseline (SV2) to 12 months post-procedure
measure: Change in Office Diastolic Blood Pressure (DBP)
timeFrame: From Baseline (SV2) to 3 month post-procedure
measure: Change in Office Diastolic Blood Pressure (DBP)
timeFrame: From Baseline (SV2) to 12 months post-procedure
measure: Incidence of Achieving Target Office Systolic Blood Pressure (SBP)
timeFrame: 3 months post-procedure
measure: Incidence of Achieving Target Office Systolic Blood Pressure (SBP)
timeFrame: 12 months post-procedure
measure: Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events
timeFrame: From Baseline (SV2) to 12 months post-procedure
measure: Incidence of Myocardial Infarction
timeFrame: From baseline (SV2) to 12 months post-procedure
measure: Incidence of Stroke
timeFrame: From baseline (SV2) to 12 months post-procedure
measure: Incidence of Renal Artery Re-intervention
timeFrame: From baseline (SV2) to 12 months post-procedure
measure: Incidence of Major Bleeding According to TIMI Definition
timeFrame: From baseline (SV2) to 12 months post-procedure
measure: Incidence of Increase in Serum Creatinine >50%
timeFrame: From baseline (SV2) to 12 months post-procedure
Other outcomes:
measure: Reduction in Systolic Blood Pressure (SBP) Over 24 Hours of ABPM as Measured With 24- Ambulatory Blood Pressure Monitor (ABPM) at 3 Months Post-procedure From Baseline
timeFrame: 3 months post-procedure
measure: Reduction in Diastolic Blood Pressure (DBP) Over 24 Hours as Measured With 24-Ambulatory Blood Pressure Monitor (ABPM) at 3 Months Post-procedure From Baseline
timeFrame: 3 Months post-procedure
measure: Office Systolic Blood Pressure (SBP) Reduction
timeFrame: From Baseline (SV2) to 3 months post-procedure
measure: Office Diastolic Blood Pressure (DBP) Reduction
timeFrame: From Baseline (SV2) to 3 months post-procedure
measure: Procedural Characteristics: Procedure Time (Minutes)
timeFrame: Procedure
measure: Procedural Characteristics: Denervation Time (Minutes)
timeFrame: Procedure
measure: Procedural Characteristics: Amount of Contrast Used (cc)
timeFrame: Procedure
Locations:
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Dallas
country: United States
facility: Baylor Heart & Vascular Hospital
state: Texas
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
city: Homburg
country: Germany
facility: Universitaetsklinikum des Saarlandes
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
city: Athens
country: Greece
facility: Hippokration General Hospital of Athens
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
Study officials:
affiliation: Stanford University
name: David P Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Wales
name: Andrew Sharp, MD
role: PRINCIPAL_INVESTIGATOR
References: