SPYRAL DYSTAL Renal Denervation Global Clinical Study

Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04311086
• Other study ID #: SPYRAL DYSTAL
• Status: Completed
• Phase: N/A
• Start date: June 12, 2020
• Est. completion date: December 22, 2022

Study information

• Verified date: April 2024
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitaetsklinikum Erlangen	Erlangen
Germany	Universitaetsklinikum des Saarlandes	Homburg
Germany	Herzzentrum Leipzig	Leipzig
Greece	Hippokration General Hospital of Athens	Athens
United Kingdom	University Hospital of Wales	Cardiff
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Baylor Heart & Vascular Hospital	Dallas	Texas
United States	Stanford Hospital and Clinics	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Countries where clinical trial is conducted

United States,  Germany,  Greece,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)		From Baseline (SV2) to 3 months post-procedure
Secondary	Change in Office Systolic Blood Pressure (SBP)		From Baseline (SV2) to 3 months post-procedure
Secondary	Change in Office Systolic Blood Pressure (SBP)		From Baseline (SV2) to 12 months post-procedure
Secondary	Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)		From Baseline (SV2) to 3 months post-procedure
Secondary	Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)		From Baseline (SV2) to 12 months post-procedure
Secondary	Change in Office Diastolic Blood Pressure (DBP)		From Baseline (SV2) to 3 month post-procedure
Secondary	Change in Office Diastolic Blood Pressure (DBP)		From Baseline (SV2) to 12 months post-procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	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 or; in the absence of CKMB: Troponin > l*URL or; 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	From baseline (SV2) to 12 months post-procedure
Secondary	Incidence of Stroke		From baseline (SV2) to 12 months post-procedure
Secondary	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
Secondary	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
Secondary	Incidence of Increase in Serum Creatinine >50%		From baseline (SV2) to 12 months post-procedure