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HypertensionNCT04311086

SPYRAL DYSTAL Renal Denervation Global Clinical Study

A study testing Renal Denervation (Symplicity Spyral™) in people with Hypertension and Vascular Diseases, run by Medtronic Vascular at 8 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Renal Denervation (Symplicity Spyral™)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
8 sitesin 4 countries
Study dates
12 Jun 2020to 22 Dec 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

8 sites in 4 countries.

8 sites in 4 countries

United States3 sites

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Baylor Heart & Vascular Hospital

    Dallas, Texas, 75226

  • Stanford Hospital and Clinics

    Stanford, California, 94305

Other trials in United States

Germany3 sites

  • Universitaetsklinikum Erlangen

    Erlangen

  • Universitaetsklinikum des Saarlandes

    Homburg

  • Herzzentrum Leipzig

    Leipzig

Other trials in Germany

Greece1 site

  • Hippokration General Hospital of Athens

    Athens

Other trials in Greece

United Kingdom1 site

  • University Hospital of Wales

    Cardiff

Other trials in United Kingdom

About this study

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)

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.

Being tested
Renal Denervation (Symplicity Spyral™)
Keywords
Uncontrolled hypertension, Renal denervation
Medical subject headings
Hypertension, Vascular Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Renal Denervation (Symplicity Spyral™)Device

    Also called Renal Angiography, Renal Denervation

    Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.

Study groups in NCT04311086
Study groupRoleWhat they receive
Renal DenervationExperimentalRenal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Receives: Device: Renal Denervation (Symplicity Spyral™)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

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

Secondary outcomes (15)

  1. Change in Systolic Blood Pressure (SBP) as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

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

  2. Change in Office Systolic Blood Pressure (SBP)

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

  3. Change in Office Systolic Blood Pressure (SBP)

    Measured: 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)

    Measured: 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)

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

  6. Change in Office Diastolic Blood Pressure (DBP)

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

  7. Change in Office Diastolic Blood Pressure (DBP)

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

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

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

    Measured: 3 months post-procedure

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

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

    Measured: 12 months post-procedure

  10. 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

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

  11. 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
    1. 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

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

  12. Incidence of Stroke

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

  13. 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.

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

  14. 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)

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

  15. Incidence of Increase in Serum Creatinine >50%

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2020
  2. Study start12 Jun 2020
  3. Primary completion22 Dec 2022
  4. Study completion22 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04311086
Sponsor's protocol ID
SPYRAL DYSTAL
Status last verified
Apr 2024
First submitted
12 Mar 2020
Last updated
17 Apr 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Bytyqi V, Kannenkeril D, Striepe K, Bosch A, Karg MV, Schmid A, Schiffer M, Uder M, Schmieder RE. Predicting blood pressure response to renal denervation based on a new approach. J Hypertens. 2025 Mar 1;43(3):413-419. doi: 10.1097/HJH.0000000000003918. Epub 2024 Oct 29.

    PubMed 39526682

  • 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.

    PubMed 38616460

Questions about this trial

What is this clinical trial studying?

A study testing Renal Denervation (Symplicity Spyral™) in people with Hypertension and Vascular Diseases, run by Medtronic Vascular at 8 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Germany, Greece, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04311086, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.

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