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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Denervation | Experimental | Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renal Denervation (Symplicity Spyral™) | Device | Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure. |
| Measure | Description | 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 |
| 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 |
| 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. |
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David P Lee, MD | Stanford University | Principal Investigator |
| Andrew Sharp, MD | University Hospital of Wales | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Hospital and Clinics | Stanford | California | 94305 | United States | ||
| Piedmont Heart Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38616460 | Derived | Sharp ASP, Kandzari DE, Townsend RR, Kario K, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Bohm M, Choi JW, Liu M, DeBruin V, Lee DP. A novel, proof-of-concept radiofrequency renal denervation strategy to improve procedural efficiency: 12-month results from the SPYRAL DYSTAL pilot study. Cardiovasc Revasc Med. 2024 Nov;68:30-36. doi: 10.1016/j.carrev.2024.04.005. Epub 2024 Apr 10. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) | Subjects with evaluable data | Posted | Mean | Standard Deviation | mmHg | From Baseline (SV2) to 12 months post-procedure |
|
|
Serious Adverse Events were monitored/assessed from subject enrollment (consent) through study exit (up to 12 Months Post Procedure) while Adverse Events were monitored/assessed from subject enrollment (consent) through 6-month visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA version 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Dinkins SPYRAL DYSTAL Global Study Manager | Medtronic | 303-840-4034 | rs.spyraldystal@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 14, 2022 | Feb 1, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 4, 2022 | Feb 29, 2024 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 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:
| 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:
Appropriate cardiac enzyme data (respecting top-down hierarchy):
| 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 |
| 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 |
| Atlanta |
| Georgia |
| 30309 |
| United States |
| Baylor Heart & Vascular Hospital | Dallas | Texas | 75226 | United States |
| Universitaetsklinikum Erlangen | Erlangen | Germany |
| Universitaetsklinikum des Saarlandes | Homburg | Germany |
| Herzzentrum Leipzig | Leipzig | Germany |
| Hippokration General Hospital of Athens | Athens | Greece |
| University Hospital of Wales | Cardiff | United Kingdom |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) | Subjects with evaluable data | Posted | Mean | Standard Deviation | mmHg | From Baseline (SV2) to 3 months post-procedure |
|
|
|
| Secondary | Change in Office Systolic Blood Pressure (SBP) | Subjects with evaluable data | Posted | Mean | Standard Deviation | mmHg | From Baseline (SV2) to 3 months post-procedure |
|
|
|
| Secondary | Change in Office Systolic Blood Pressure (SBP) | Posted | Mean | Standard Deviation | mmHg | 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) | Subjects with evaluable data | Posted | Mean | Standard Deviation | mmHg | 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) | Subjects with evaluable data | Posted | Mean | Standard Deviation | mmHg | From Baseline (SV2) to 12 months post-procedure |
|
|
|
| Secondary | Change in Office Diastolic Blood Pressure (DBP) | Subjects with evaluable data | Posted | Mean | Standard Deviation | mmHg | From Baseline (SV2) to 3 month post-procedure |
|
|
|
| Secondary | Change in Office Diastolic Blood Pressure (DBP) | Posted | Mean | Standard Deviation | mmHg | 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) | Subjects with evaluable data | Posted | Count of Participants | Participants | 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) | Posted | Count of Participants | Participants | 12 months post-procedure |
|
|
|
| Secondary | Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events | Incidence of the following events:
| Posted | Count of Participants | Participants | 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:
Appropriate cardiac enzyme data (respecting top-down hierarchy):
| Posted | Count of Participants | Participants | From baseline (SV2) to 12 months post-procedure |
|
|
|
| Secondary | Incidence of Stroke | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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) | Posted | Count of Participants | Participants | From baseline (SV2) to 12 months post-procedure |
|
|
|
| Secondary | Incidence of Increase in Serum Creatinine >50% | Subjects with evaluable data | Posted | Count of Participants | Participants | From baseline (SV2) to 12 months post-procedure |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | 3 months post-procedure |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | 3 Months post-procedure |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | From Baseline (SV2) to 3 months post-procedure |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | From Baseline (SV2) to 3 months post-procedure |
|
|
|
|
| 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. | 56 Subjects from the SPYRAL DYSTAL study and 182 Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). | Posted | Mean | Standard Deviation | Minutes | Procedure |
|
|
|
| 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. | 56 Subjects from the SPYRAL DYSTAL study and 182 Subjects from the SPYRAL HTN-OFF MED study (NCT02439749). | Posted | Mean | Standard Deviation | Minutes | Procedure |
|
|
|
| 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. | 56 Subjects from the SPYRAL DYSTAL study and 178 Subjects from the SPYRAL HTN-OFF MED study (NCT02439749) with evaluable data. | Posted | Mean | Standard Deviation | (cubic centimeter(cc)) | Procedure |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | 12 months post-procedure |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | 12 months post-procedure |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | From Baseline (SV2) to 12 months post-procedure |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | From Baseline (SV2) to 12 months post-procedure |
|
|
|
|
| 0 |
| 56 |
| 7 |
| 56 |
| 38 |
| 56 |
| Appendicitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Renal artery dissection | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Renal infarct | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Sinus arrest | Cardiac disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Swelling face | General disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Immunisation reaction | Immune system disorders | MedDRA version 25.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA version 25.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
|
| Muscle contusion | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
|
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
|
| Vascular access site haematoma | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
|
| Vascular access site haemorrhage | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
|
| Vascular access site pain | Injury, poisoning and procedural complications | MedDRA version 25.0 | Systematic Assessment |
|
| Blood aldosterone increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MedDRA version 25.0 | Systematic Assessment |
|
| Blood testosterone decreased | Investigations | MedDRA version 25.0 | Systematic Assessment |
|
| Carotid pulse abnormal | Investigations | MedDRA version 25.0 | Systematic Assessment |
|
| Computerised tomogram kidney abnormal | Investigations | MedDRA version 25.0 | Systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA version 25.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA version 25.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA version 25.0 | Systematic Assessment |
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| Stress | Psychiatric disorders | MedDRA version 25.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
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| Renal artery dissection | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
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| Renal infarct | Renal and urinary disorders | MedDRA version 25.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.0 | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
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| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA version 25.0 | Systematic Assessment |
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| Essential hypertension | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA version 25.0 | Systematic Assessment |
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Not provided
Not provided
| Title | Measurements |
|---|---|
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| Significant Embolic Event, Kidney |
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| Renal artery perforation requiring intervention |
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| Renal artery dissection requiring intervention |
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| Vascular complications |
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| Hospitalization for hypertensive crisis |
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| New renal artery stenosis >70% |
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