SPYRAL DYSTAL Renal Denervation Global Clinical Study

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)

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 Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Intervention / Treatment: Device: Renal Denervation (Symplicity Spyral™)

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany
    • Universitaetsklinikum Erlangen
  • Homburg, Germany
    • Universitaetsklinikum des Saarlandes
  • Leipzig, Germany
    • Herzzentrum Leipzig
• Greece
  • Athens, Greece
    • Hippokration General Hospital of Athens
• United Kingdom
  • Cardiff, United Kingdom
    • University Hospital of Wales
• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Hospital and Clinics
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
  • Texas
    • Dallas, Texas, United States, 75226
      • Baylor Heart & Vascular Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Renal Denervation; Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)	Device: Renal Denervation (Symplicity Spyral™); Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.; Other Names: Renal Denervation; Renal Angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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 Office Systolic Blood Pressure (SBP)		From Baseline (SV2) to 3 months post-procedure
Change in Office Systolic Blood Pressure (SBP)		From Baseline (SV2) to 12 months post-procedure
Change in Diastolic Blood Pressure (DBP) 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 3 month post-procedure
Change in Office Diastolic Blood Pressure (DBP)		From Baseline (SV2) to 12 months post-procedure
Incidence of Achieving Target Office Systolic Blood Pressure (SBP)	Target blood pressure defined as <140 mmHg office Systolic Blood Pressure (SBP)	3 months post-procedure
Incidence of Achieving Target Office Systolic Blood Pressure (SBP)	Target blood pressure defined as <140 mmHg office Systolic Blood Pressure (SBP)	12 months post-procedure
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events	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	From Baseline (SV2) to 12 months post-procedure
Incidence of Myocardial Infarction	Defined as the concurrent documentation of two of the three elements listed below in the appropriate clinical circumstance: Chest pain or ischemic equivalent; New pathologic q waves in at least 2 contiguous ECG leads; Cardiac biomarker elevation by any of the definitions below: Appropriate cardiac enzyme data (respecting top-down hierarchy): CK greater than or equal to 2* URL confirmed by:CKMB > l*URL orin the absence of CKMB: Troponin > l*URL or; in the absence of CK:CKMB > 3*URLIn the absence of CK and CKMB: Troponin > 3*URLIn the absence of CK, CKMB and Troponin, clinical decision based upon clinical scenario	From baseline (SV2) to 12 months post-procedure
Incidence of Stroke		From baseline (SV2) to 12 months post-procedure
Incidence of Renal Artery Re-intervention	Interventional procedure performed on the renal artery following completion of the renal denervation procedure and removal of the guide catheter.	From baseline (SV2) to 12 months post-procedure
Incidence of Major Bleeding According to TIMI Definition	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)	From baseline (SV2) to 12 months post-procedure
Incidence of Increase in Serum Creatinine >50%		From baseline (SV2) to 12 months post-procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Comparison of systolic blood pressure reduction over 24 hours of ABPM between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.	3 months post-procedure
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	Comparison of diastolic blood pressure reduction over 24 hours of ABPM between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.	3 Months post-procedure
Office Systolic Blood Pressure (SBP) Reduction	Comparison of Office Systolic Blood Pressure (SBP) reduction between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.	From Baseline (SV2) to 3 months post-procedure
Office Diastolic Blood Pressure (DBP) Reduction	Comparison of Office Diastolic Blood Pressure (DBP) reduction between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.	From Baseline (SV2) to 3 months post-procedure
Procedural Characteristics: Procedure Time (Minutes)	Comparison of procedural characteristics: total procedure duration (minutes) between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.	Procedure
Procedural Characteristics: Denervation Time (Minutes)	Comparison of the procedural characteristics: total denervation time between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.	Procedure
Procedural Characteristics: Amount of Contrast Used (cc)	Comparison of the procedural characteristics: amount of contrast used (cubic centimeter(cc)) between the SPYRAL DYSTAL study and the SPYRAL HTN-OFF MED study (NCT02439749) who, after a renal angiography according to standard procedures, are treated with the renal denervation procedure.	Procedure

Collaborators and Investigators

• Sponsor: Medtronic Vascular
• Investigators: Principal Investigator: David P Lee, MD, Stanford University; Principal Investigator: Andrew Sharp, MD, University Hospital of Wales

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): December 22, 2022

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Uncontrolled hypertension; Renal denervation
• Additional Relevant MeSH Terms: Hypertension; Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: SPYRAL DYSTAL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes