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OpenTrials
Completed

NCT Number: NCT04311086

SPYRAL DYSTAL Renal Denervation Global Clinical Study

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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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitaetsklinikum Erlangen, Erlangen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Renal Angiography, Renal Denervation

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Change in Office Systolic Blood Pressure (SBP)

    Time frame: From Baseline (SV2) to 3 months post-procedure

  3. Change in Office Systolic Blood Pressure (SBP)

    Time frame: From Baseline (SV2) to 12 months post-procedure

  4. 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

  5. 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

  6. Change in Office Diastolic Blood Pressure (DBP)

    Time frame: From Baseline (SV2) to 3 month post-procedure

  7. Change in Office Diastolic Blood Pressure (DBP)

    Time frame: From Baseline (SV2) to 12 months post-procedure

  8. Incidence of Achieving Target Office Systolic Blood Pressure (SBP)

    Time frame: 3 months post-procedure

    Target blood pressure defined as <140 mmHg office Systolic Blood Pressure (SBP)

  9. Incidence of Achieving Target Office Systolic Blood Pressure (SBP)

    Time frame: 12 months post-procedure

    Target blood pressure defined as <140 mmHg office Systolic Blood Pressure (SBP)

  10. Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events

    Time frame: 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

  11. Incidence of Myocardial Infarction

    Time frame: 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:

    • 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

  12. Incidence of Stroke

    Time frame: From baseline (SV2) to 12 months post-procedure

  13. Incidence of Renal Artery Re-intervention

    Time frame: 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.

  14. Incidence of Major Bleeding According to TIMI Definition

    Time frame: 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)

  15. Incidence of Increase in Serum Creatinine >50%

    Time frame: From baseline (SV2) to 12 months post-procedure

Other outcomes

  1. 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

    Time frame: 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.

  2. 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

    Time frame: 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.

  3. Office Systolic Blood Pressure (SBP) Reduction

    Time frame: 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.

  4. Office Diastolic Blood Pressure (DBP) Reduction

    Time frame: 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.

  5. Procedural Characteristics: Procedure Time (Minutes)

    Time frame: 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.

  6. Procedural Characteristics: Denervation Time (Minutes)

    Time frame: 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.

  7. Procedural Characteristics: Amount of Contrast Used (cc)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Official study 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)

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2020
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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