Cardiovascular Diseases, Hypertension, Vascular Diseases
Conditions
Keywords
Uncontrolled hypertension, Renal denervation
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.
Interventions
Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
Sponsors
Medtronic Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) | From Baseline (SV2) to 3 months post-procedure | — |
| Incidence of Achieving Target Office Systolic Blood Pressure (SBP) | 3 months post-procedure | Target blood pressure defined as \<140 mmHg office Systolic Blood Pressure (SBP) |
| 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 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 | — |
| 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 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 Increase in Serum Creatinine >50% | 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 Office Systolic Blood Pressure (SBP) | From Baseline (SV2) to 3 months post-procedure | — |
| Change in Office Diastolic Blood Pressure (DBP) | From Baseline (SV2) to 3 month post-procedure | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Office Systolic Blood Pressure (SBP) Reduction | From Baseline (SV2) to 3 months post-procedure | 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. |
| Office Diastolic Blood Pressure (DBP) Reduction | From Baseline (SV2) to 3 months post-procedure | 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. |
| Procedural Characteristics: Procedure Time (Minutes) | Procedure | 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. |
| Procedural Characteristics: Denervation Time (Minutes) | Procedure | 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. |
| Procedural Characteristics: Amount of Contrast Used (cc) | Procedure | 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. |
| 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 | 3 months post-procedure | 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. |
| 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 | 3 Months post-procedure | 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. |
Countries
Germany, Greece, United Kingdom, United States
Participant flow
Pre-assignment details
Comparison of this 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 have been made for several end points and noted in the descriptions.
Participants by arm
| Arm | Count |
|---|---|
| Renal Denervation Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
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. | 56 |
| Total | 56 |
Baseline characteristics
| Characteristic | Renal Denervation |
|---|---|
| Age, Continuous | 56.3 Years STANDARD_DEVIATION 9.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 27 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment Germany | 14 participants |
| Region of Enrollment Greece | 7 participants |
| Region of Enrollment Italy | 6 participants |
| Region of Enrollment United Kingdom | 5 participants |
| Region of Enrollment United States | 24 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 56 |
| other Total, other adverse events | 38 / 56 |
| serious Total, serious adverse events | 7 / 56 |
Outcome results
Primary
Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: From Baseline (SV2) to 12 months post-procedure
Population: Subjects with evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) | -16.6 mmHg | Standard Deviation 10.6 |
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
Time frame: From Baseline (SV2) to 12 months post-procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Renal Denervation | Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events | All Cause Mortality | 0 Participants |
| Renal Denervation | Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events | End-stage renal disease (ESRD) | 0 Participants |
| Renal Denervation | Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events | Significant embolic event resulting in end-organ damage | 2 Participants |
| Renal Denervation | Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events | Significant Embolic Event, Kidney | 2 Participants |
| Renal Denervation | Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events | Renal artery perforation requiring intervention | 0 Participants |
| Renal Denervation | Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events | Renal artery dissection requiring intervention | 0 Participants |
| Renal Denervation | Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events | Vascular complications | 0 Participants |
| Renal Denervation | Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events | Hospitalization for hypertensive crisis | 0 Participants |
| Renal Denervation | Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events | New renal artery stenosis >70% | 0 Participants |
Secondary
Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: From Baseline (SV2) to 12 months post-procedure
Population: Subjects with evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) | -11.2 mmHg | Standard Deviation 8.2 |
Secondary
Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: From Baseline (SV2) to 3 months post-procedure
Population: Subjects with evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Diastolic Blood Pressure (DBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) | -1.1 mmHg | Standard Deviation 7.5 |
Secondary
Change in Office Diastolic Blood Pressure (DBP)
Time frame: From Baseline (SV2) to 12 months post-procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Office Diastolic Blood Pressure (DBP) | -9.8 mmHg | Standard Deviation 10.8 |
Secondary
Change in Office Diastolic Blood Pressure (DBP)
Time frame: From Baseline (SV2) to 3 month post-procedure
Population: Subjects with evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Office Diastolic Blood Pressure (DBP) | -4.1 mmHg | Standard Deviation 8.5 |
Secondary
Change in Office Systolic Blood Pressure (SBP)
Time frame: From Baseline (SV2) to 12 months post-procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Office Systolic Blood Pressure (SBP) | -20.3 mmHg | Standard Deviation 16.3 |
Secondary
Change in Office Systolic Blood Pressure (SBP)
Time frame: From Baseline (SV2) to 3 months post-procedure
Population: Subjects with evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Office Systolic Blood Pressure (SBP) | -9.0 mmHg | Standard Deviation 13.9 |
Secondary
Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
Time frame: From Baseline (SV2) to 3 months post-procedure
Population: Subjects with evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Renal Denervation | Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) | -1.4 mmHg | Standard Deviation 10 |
Secondary
Incidence of Achieving Target Office Systolic Blood Pressure (SBP)
Target blood pressure defined as \<140 mmHg office Systolic Blood Pressure (SBP)
Time frame: 3 months post-procedure
Population: Subjects with evaluable data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Incidence of Achieving Target Office Systolic Blood Pressure (SBP) | 8 Participants |
Secondary
Incidence of Achieving Target Office Systolic Blood Pressure (SBP)
Target blood pressure defined as \<140 mmHg office Systolic Blood Pressure (SBP)
Time frame: 12 months post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Incidence of Achieving Target Office Systolic Blood Pressure (SBP) | 27 Participants |
Secondary
Incidence of Increase in Serum Creatinine >50%
Time frame: From baseline (SV2) to 12 months post-procedure
Population: Subjects with evaluable data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Incidence of Increase in Serum Creatinine >50% | 0 Participants |
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)
Time frame: From baseline (SV2) to 12 months post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Incidence of Major Bleeding According to TIMI Definition | 0 Participants |
Secondary
Incidence of Myocardial Infarction
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
Time frame: From baseline (SV2) to 12 months post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Incidence of Myocardial Infarction | 0 Participants |
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.
Time frame: From baseline (SV2) to 12 months post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Incidence of Renal Artery Re-intervention | 0 Participants |
Secondary
Incidence of Stroke
Time frame: From baseline (SV2) to 12 months post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Renal Denervation | Incidence of Stroke | 0 Participants |
Post Hoc
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.
Time frame: From Baseline (SV2) to 12 months post-procedure
Population: 56 Subjects from the SPYRAL DYSTAL study and 171 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with Office DBP change as dependent variable. Treatment and baseline Office DBP as independent variables. In subjects with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Denervation | Office Diastolic Blood Pressure (DBP) Reduction | SPYRAL DYSTAL | -9.8 mmHg | Standard Deviation 10.8 |
| Renal Denervation | Office Diastolic Blood Pressure (DBP) Reduction | SPYRAL HTN-OFF MED | -10.7 mmHg | Standard Deviation 8.8 |
Comparison: Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.p-value: >0.05ANCOVA
Other Pre-specified
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.
Time frame: From Baseline (SV2) to 3 months post-procedure
Population: 55 Subjects from the SPYRAL DYSTAL study and 170 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with Office DBP change as dependent variable. Treatment and baseline Office DBP as independent variables. In subjects with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Denervation | Office Diastolic Blood Pressure (DBP) Reduction | SPYRAL DYSTAL | -4.1 mmHg | Standard Deviation 8.5 |
| Renal Denervation | Office Diastolic Blood Pressure (DBP) Reduction | SPYRAL HTN-OFF MED | -5.0 mmHg | Standard Deviation 8.3 |
Comparison: Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.p-value: >0.05ANCOVA
Other Pre-specified
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.
Time frame: From Baseline (SV2) to 3 months post-procedure
Population: 55 Subjects from the SPYRAL DYSTAL study and 170 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with Office SBP change as dependent variable. Treatment and baseline Office SBP as independent variables. In subjects with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Denervation | Office Systolic Blood Pressure (SBP) Reduction | SPYRAL DYSTAL | -9.0 mmHg | Standard Deviation 13.9 |
| Renal Denervation | Office Systolic Blood Pressure (SBP) Reduction | SPYRAL HTN-OFF MED | -9.4 mmHg | Standard Deviation 14.8 |
Comparison: Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustmentp-value: >0.05ANCOVA
Post Hoc
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.
Time frame: From Baseline (SV2) to 12 months post-procedure
Population: 56 Subjects from the SPYRAL DYSTAL study and 171 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with Office SBP change as dependent variable. Treatment and baseline Office SBP as independent variables. In subjects with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Denervation | Office Systolic Blood Pressure (SBP) Reduction | SPYRAL DYSTAL | -20.3 mmHg | Standard Deviation 16.3 |
| Renal Denervation | Office Systolic Blood Pressure (SBP) Reduction | SPYRAL HTN-OFF MED | -21.3 mmHg | Standard Deviation 14.2 |
Comparison: Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.p-value: >0.05ANCOVA
Other Pre-specified
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.
Time frame: Procedure
Population: 56 Subjects from the SPYRAL DYSTAL study and 178 Subjects from the SPYRAL HTN-OFF MED study (NCT02439749) with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Denervation | Procedural Characteristics: Amount of Contrast Used (cc) | SPYRAL DYSTAL | 172.8 (cubic centimeter(cc)) | Standard Deviation 76.6 |
| Renal Denervation | Procedural Characteristics: Amount of Contrast Used (cc) | SPYRAL HTN-OFF MED | 207.8 (cubic centimeter(cc)) | Standard Deviation 96.1 |
Other Pre-specified
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.
Time frame: Procedure
Population: 56 Subjects from the SPYRAL DYSTAL study and 182 Subjects from the SPYRAL HTN-OFF MED study (NCT02439749).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Denervation | Procedural Characteristics: Denervation Time (Minutes) | SPYRAL DYSTAL | 35.9 Minutes | Standard Deviation 13.8 |
| Renal Denervation | Procedural Characteristics: Denervation Time (Minutes) | SPYRAL HTN-OFF MED | 59.7 Minutes | Standard Deviation 24.3 |
Other Pre-specified
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.
Time frame: Procedure
Population: 56 Subjects from the SPYRAL DYSTAL study and 182 Subjects from the SPYRAL HTN-OFF MED study (NCT02439749).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Denervation | Procedural Characteristics: Procedure Time (Minutes) | SPYRAL DYSTAL | 67.3 Minutes | Standard Deviation 20.6 |
| Renal Denervation | Procedural Characteristics: Procedure Time (Minutes) | SPYRAL HTN-OFF MED | 99.3 Minutes | Standard Deviation 36.2 |
Post Hoc
Reduction in Diastolic Blood Pressure (DBP) Over 24 Hours as Measured With 24-Ambulatory Blood Pressure Monitor (ABPM) at 12 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.
Time frame: 12 months post-procedure
Population: 46 Subjects from the SPYRAL DYSTAL study and 146 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with 24-hr DBP change as dependent variable. Treatment and baseline 24-hr DBP as independent variables. In subjects with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Denervation | Reduction in Diastolic Blood Pressure (DBP) Over 24 Hours as Measured With 24-Ambulatory Blood Pressure Monitor (ABPM) at 12 Months Post-procedure From Baseline | SPYRAL DYSTAL | -11.2 mmHg | Standard Deviation 8.2 |
| Renal Denervation | Reduction in Diastolic Blood Pressure (DBP) Over 24 Hours as Measured With 24-Ambulatory Blood Pressure Monitor (ABPM) at 12 Months Post-procedure From Baseline | SPYRAL HTN-OFF MED | -10.2 mmHg | Standard Deviation 8.2 |
p-value: <0.05ANCOVA
Other Pre-specified
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.
Time frame: 3 Months post-procedure
Population: 53 Subjects from the SPYRAL DYSTAL study and 153 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with 24-hr DBP change as dependent variable. Treatment and baseline 24-hr DBP as independent variables. In subjects with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Denervation | 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 | SPYRAL DYSTAL | -1.1 mmHg | Standard Deviation 7.5 |
| Renal Denervation | 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 | SPYRAL HTN-OFF MED | -3.5 mmHg | Standard Deviation 6.7 |
Comparison: Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.p-value: >0.05ANCOVA
Post Hoc
Reduction in Systolic Blood Pressure (SBP) Over 24 Hours of ABPM as Measured With 24-Ambulatory Blood Pressure Monitor (ABPM) at 12 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.
Time frame: 12 months post-procedure
Population: 46 Subjects from the SPYRAL DYSTAL study and 146 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with 24-hr SBP change as dependent variable. Treatment and baseline 24-hr SBP as independent variables. In subjects with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Denervation | Reduction in Systolic Blood Pressure (SBP) Over 24 Hours of ABPM as Measured With 24-Ambulatory Blood Pressure Monitor (ABPM) at 12 Months Post-procedure From Baseline | SPYRAL DYSTAL | -16.6 mmHg | Standard Deviation 10.6 |
| Renal Denervation | Reduction in Systolic Blood Pressure (SBP) Over 24 Hours of ABPM as Measured With 24-Ambulatory Blood Pressure Monitor (ABPM) at 12 Months Post-procedure From Baseline | SPYRAL HTN-OFF MED | -14.3 mmHg | Standard Deviation 11.9 |
Comparison: Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.p-value: <0.05ANCOVA
Other Pre-specified
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.
Time frame: 3 months post-procedure
Population: 53 Subjects from the SPYRAL DYSTAL study and 153 Intent-to-Treat Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). Within each of the 5 strata ANCOVA model with 24-hr SBP change as dependent variable. Treatment and baseline 24-hr SBP as independent variables. In subjects with evaluable data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Renal Denervation | 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 | SPYRAL DYSTAL | -1.4 mmHg | Standard Deviation 10 |
| Renal Denervation | 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 | SPYRAL HTN-OFF MED | -4.5 mmHg | Standard Deviation 10.8 |
Comparison: Comparison to the SPYRAL HTN-OFF MED study (NCT02439749) using a propensity score stratification (sub classification) adjustment.p-value: >0.05ANCOVA