SPYRAL DYSTAL Renal Denervation Global Clinical Study

Not Applicable

Completed

Conditions: Hypertension
Vascular Diseases
Cardiovascular Diseases

Interventions: Device: Renal Denervation (Symplicity Spyral™)

Registration Number: NCT04311086

Lead Sponsor: Medtronic Vascular

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 128

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal Denervation	Renal Denervation (Symplicity Spyral™)	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)

Primary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)	From Baseline (SV2) to 12 months post-procedure

Secondary Outcome Measures

Name	Time	Method
Incidence of Increase in Serum Creatinine >50%	From baseline (SV2) to 12 months post-procedure
Change in Office Systolic Blood Pressure (SBP)	From Baseline (SV2) to 12 months post-procedure
Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)	From Baseline (SV2) to 3 months post-procedure
Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)	From Baseline (SV2) to 12 months post-procedure
Change in Office Diastolic Blood Pressure (DBP)	From Baseline (SV2) to 12 months post-procedure
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events	From Baseline (SV2) to 12 months post-procedure	Incidence of the following events: * All-cause mortality * End-stage renal disease (ESRD) * Significant embolic event resulting in end-organ damage * Renal artery perforation requiring intervention * Renal artery dissection requiring intervention * Vascular complications * Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol * New renal artery stenosis \>70%, confirmed by angiography and as determined by the angiographic core lab at 6 months follow up
Incidence of Major Bleeding According to TIMI Definition	From baseline (SV2) to 12 months post-procedure	Intracranial hemorrhage; ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within seven days of the procedure)
Incidence of Achieving Target Office Systolic Blood Pressure (SBP)	12 months post-procedure	Target blood pressure defined as \<140 mmHg office Systolic Blood Pressure (SBP)
Incidence of Renal Artery Re-intervention	From baseline (SV2) to 12 months post-procedure	Interventional procedure performed on the renal artery following completion of the renal denervation procedure and removal of the guide catheter.
Incidence of Myocardial Infarction	From baseline (SV2) to 12 months post-procedure	Defined as the concurrent documentation of two of the three elements listed below in the appropriate clinical circumstance: 1. Chest pain or ischemic equivalent 2. New pathologic q waves in at least 2 contiguous ECG leads 3. Cardiac biomarker elevation by any of the definitions below: Appropriate cardiac enzyme data (respecting top-down hierarchy): 1. CK greater than or equal to 2\* URL confirmed by: * CKMB \> l\URL or in the absence of CKMB: Troponin \> l\URL or 2. in the absence of CK: CKMB \> 3\URL In the absence of CK and CKMB: Troponin \> 3\URL In the absence of CK, CKMB and Troponin, clinical decision based upon clinical scenario
Incidence of Stroke	From baseline (SV2) to 12 months post-procedure

Trial Locations

Locations (8): Herzzentrum Leipzig
🇩🇪
Leipzig, Germany
Stanford Hospital and Clinics
🇺🇸
Stanford, California, United States
Baylor Heart & Vascular Hospital
🇺🇸
Dallas, Texas, United States
Piedmont Heart Institute
🇺🇸
Atlanta, Georgia, United States
Hippokration General Hospital of Athens
🇬🇷
Athens, Greece
Universitaetsklinikum Erlangen
🇩🇪
Erlangen, Germany
Universitaetsklinikum des Saarlandes
🇩🇪
Homburg, Germany
University Hospital of Wales
🇬🇧
Cardiff, United Kingdom