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HypertensionNCT02439749

SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

A study testing Symplicity Spyral™ multi-electrode renal denervation system in people with Hypertension and Vascular Diseases, run by Medtronic Vascular at 47 sites in 9 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Symplicity Spyral™ multi-electrode renal denervation system
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
366 participants
Where
47 sitesin 9 countries
Study dates
Jun 2015to 25 Oct 2023
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 lacks appropriate renal artery anatomy.
  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

47 sites in 9 countries.

47 sites in 9 countries

United States30 sites

  • AnMed Health

    Anderson, South Carolina, 29621

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Charleston Area Medical Center

    Charleston, West Virginia, 25304

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Baylor Heart & Vascular Hospital

    Dallas, Texas, 75226

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • PinnacleHealth Cardiovascular Institute

    Harrisburg, Pennsylvania, 17011

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Heart Center Research, LLC

    Huntsville, Alabama, 35801

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida, 32207

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Kaiser Permanente LA Medical Center

    Los Angeles, California, 90027

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Centennial Medical Center

    Nashville, Tennessee, 37203

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • St Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Honor Health Research Institute

    Scottsdale, Arizona, 85258

  • Providence Hospital

    Southfield, Michigan, 48075

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford Hospital and Clinics

    Stanford, California, 94305

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

  • Cardiology Associates Research LLC

    Tupelo, Mississippi, 38801

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

Other trials in United States

Germany5 sites

  • Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH

    Bad Krozingen, 79189

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsklinikum des Saarlandes

    Homburg, 66421

  • Herzzentrum Leipzig, Universitätsklinik

    Leipzig, 04289

  • Sana Kliniken Lübeck

    Lübeck, 23560

Other trials in Germany

United Kingdom3 sites

  • Cardiff and Vale University Health Board - University Hospital of Wales

    Cardiff

  • Royal Devon & Exeter NHS Foundation Trust

    Exeter, EX2 5DW

  • Imperial College Healthcare NHS Trust

    London, W12 0HS

Other trials in United Kingdom

Canada2 sites

  • Institut de cardiologie de Montréal / Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Greece2 sites

  • Hippokration General Hospital of Athens

    Athens, 11527

  • University General Hospital of Thessaloniki (AHEPA)

    Thessaloniki, 54621

Other trials in Greece

Japan2 sites

  • Mitsui Memorial Hospital

    Chiyoda City, Tokyo, 101-8643

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329-0498

Other trials in Japan

Australia1 site

  • Alfred Hospital

    Melbourne, Victoria, 3004

Other trials in Australia

Austria1 site

  • Klinikum Wels-Grieskirchen

    Wels, 4600

Other trials in Austria

Ireland1 site

  • Galway University Hospital

    Galway

Other trials in Ireland

About this study

Official title: Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED)

The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.

Being tested
Symplicity Spyral™ multi-electrode renal denervation system, Sham Procedure
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.

  • Symplicity Spyral™ multi-electrode renal denervation systemDevice

    Also called Renal angiography, Renal Denervation

    After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

  • Sham ProcedureProcedure or surgery

    Also called Renal angiography

    After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Study groups in NCT02439749
Study groupRoleWhat they receive
Renal DenervationExperimentalRenal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Receives: Device: Symplicity Spyral™ multi-electrode renal denervation system
Sham ProcedureSham comparatorRenal angiography
Receives: Procedure: Sham Procedure

What is being measured

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

  1. Number of Participants With Major Adverse Events (MAE) Defined as a Composite of 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% (6 months for new renal artery stenosis)

    Measured: From baseline to 1 month post-procedure (6 months for new renal artery stenosis)

  2. Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring

    The outcome measure is the change in ambulatory systolic blood pressure from baseline to 3-month. The unadjusted treatment difference between renal denervation and sham control groups is -3.9 mmHg. The baseline adjusted treatment difference is -3.9 mmHg.

    Measured: From baseline to 3 months post-procedure

Secondary outcomes (44)

  1. Number of Participants With Significant Embolic Event Resulting in End-organ Damage

    Significant embolic event resulting in end-organ damage (e.g. kidney/bowel infarct, lower extremity ulceration or gangrene, or doubling of serum creatinine documented by at least two measurements at least 21 days apart)

    Measured: From baseline to 1 month post-procedure

  2. Number of Participants With Renal Artery Perforation Requiring Intervention

    Renal artery perforation requiring intervention

    Measured: From baseline to 1 month post-procedure

  3. Renal Artery Dissection

    Number of Participants with Renal artery dissection requiring intervention

    Measured: From baseline to 1 month post-procedure

  4. Number of Participants With Vascular Complications

    Vascular complications (e.g., clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm, excessive bleeding) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion (requiring more than 2 units of packed red blood cells within any 24 hour period during the first 7 days post renal denervation procedure).

    Measured: From baseline to 1 month post-procedure

  5. Number of Participants With End-stage Renal Disease

    defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:

    • Volume management refractory to diuretics
    • Hyperkalemia unmanageable by diet and diuretics
    • Acidosis bicarbonate <18 unmanageable with HCO3 supplements
    • Symptoms of uremia, nausea, vomiting

    Measured: From baseline to 1 month post-procedure

  6. Number of Participants With Decline in eGFR

    ≥40% decline in eGFR

    Measured: From baseline to 1 month post-procedure

  7. Myocardial Infarction

    Number of Participants with New myocardial infarction

    Measured: From baseline to 1 month post-procedure

  8. New Stroke

    Number of Participants with New stroke

    Measured: From baseline to 1 month post-procedure

  9. Number of Participants With Renal Artery Re-intervention

    Renal artery re-intervention

    Measured: From baseline to 1 month post-procedure

  10. Number of Participants With Major Bleeding According to TIMI Definition

    Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure).

    Measured: From baseline to 1 month post-procedure

  11. Number of Participants With Increase in Serum Creatinine

    Increase in serum creatinine > 50% from screening visit 2.

    Measured: From baseline to 1 month post-procedure

  12. Number of Participants With Hospitalization for Hypertensive Crisis With Medications or the Protocol

    Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol.

    Measured: From baseline to 1 month post-procedure

  13. Change in Office Systolic Blood Pressure

    Change in office systolic blood pressure from baseline (Screening Visit 2) to 1-month

    Measured: From baseline to 1 month post procedure

  14. Change in Office Diastolic Blood Pressure

    Change in office diastolic blood pressure from baseline (Screening Visit 2)

    Measured: From baseline to 1 month post procedure

  15. Number of Participants Achieving Target Office Systolic Blood Pressure

    Incidence of achieving target office systolic blood pressure (SBP <140 mmHg)

    Measured: From baseline to 1 month post procedure

  16. Baseline Adjusted Change (Using Analysis of Covariance) in Office Systolic Blood Pressure

    The outcome measure is the change in office systolic blood pressure from baseline to 3-month. The unadjusted treatment difference between renal denervation and sham control groups is -7.0 mmHg. The baseline adjusted treatment difference is -6.9 mmHg.

    Measured: From baseline to 3 months post-procedure

  17. Number of Participants With All-cause Mortality

    All-cause mortality

    Measured: From baseline to 3 months post-procedure

  18. Number of Participants With ≥40% Decline in eGFR

    ≥40% Decline in eGFR

    Measured: From baseline to 3 months post randomization

  19. Number of Participants With End-Stage Renal Disease (ESRD)

    Defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:

    • Volume management refractory to diuretics
    • Hyperkalemia unmanageable by diet and diuretics
    • Acidosis bicarbonate <18 unmanageable with HCO3 supplements
    • Symptoms of uremia, nausea, vomiting

    Measured: From baseline to 3 months post randomization

  20. Number of Participants With New Myocardial Infarction

    New Myocardial Infarction

    Measured: From baseline to 3 months post randomization

  21. New Stroke

    Number of Participants with New Stroke

    Measured: From baseline to 3 months post randomization

  22. Number of Participants With Renal Artery Re-intervention

    Renal Artery Re-intervention

    Measured: From baseline to 3 months post randomization

  23. Number of Participants With Major Bleeding According to TIMI Definition

    Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure).

    Measured: From baseline to 3 months post randomization

  24. Increase in Serum Creatinine

    Number of Participants with Increase in Serum Creatinine > 50% from screening visit 2.

    Measured: From baseline to 3 months post randomization

  25. Number of Participants With Hospitalization for Hypertensive Crisis

    Hospitalization for Hypertensive Crisis Not Related to Confirmed Nonadherence With Medications or the Protocol

    Measured: From baseline to 3 months post randomization

  26. Change in Diastolic Blood Pressure as Measured by 24-hour ABPM

    Change in diastolic blood pressure from baseline (screening visit 2) to 3-month as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).

    Measured: From baseline to 3 months post procedure

  27. Change in Office Diastolic Blood Pressure

    Change in Office Diastolic Blood Pressure From Baseline (Screening Visit 2) to 3-months

    Measured: From baseline to 3 months post procedure

  28. Number of Participants Achieving Target Office Systolic Blood Pressure

    Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)

    Measured: From baseline to 3 months post procedure

  29. Number of Participants With New Renal Artery Stenosis > 70%

    Confirmed by angiography and as determined by the angiographic core laboratory.

    Measured: From baseline to 6 month post-procedure

  30. Change in Systolic Blood Pressure as Measured by 24-hour ABPM

    Measured: From baseline to 36 month post-procedure

  31. Change in Diastolic Blood Pressure as Measured by 24-hour ABPM

    Change in diastolic blood pressure as measured by 24-hour ABPM

    Measured: From baseline to 36 months post-procedure

  32. Change in Office Systolic Blood Pressure

    Change in Office Systiloc Blood Pressure From Baseline (Screening Visit 2) to 36 months.

    Measured: From baseline to 36 months post procedure

  33. Change in Office Diastolic Blood Pressure

    Change in office diastolic blood pressure

    Measured: From baseline to 36 months post-procedure

  34. Number of Participants With Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140) mmHg)

    Measured: From baseline to 36 months post-procedure

  35. Number of Participants With All-cause Mortality

    Measured: From baseline to 36 months post-randomization

  36. Number of Participants With End-Stage Renal Disease (ESRD)

    Defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:

    • Volume management refractory to diuretics
    • Hyperkalemia unmanageable by diet and diuretics
    • Acidosis bicarbonate <18 unmanageable with HCO3 supplements
    • Symptoms of uremia, nausea, vomiting

    Measured: From baseline to 36 months post randomization

  37. Number of Participants With ≥40% Decline in eGFR

    ≥40% Decline in eGFR

    Measured: From baseline to 36 months post randomization

  38. Number of Participants With New Myocardial Infarction

    New Myocardial Infarction

    Measured: From baseline to 36 months post randomization

  39. Number of Participants With New Stroke

    New Stroke

    Measured: From baseline to 36 months post randomization

  40. Number of Participants With Renal Artery Re-intervention

    Renal Artery Re-intervention

    Measured: From baseline to 36 months post randomization

  41. Number of Participants With Major Bleeding According to TIMI Definition

    Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure).

    Measured: From baseline to 36 months post randomization

  42. Number of Participants With an Increase in Serum Creatinine

    Number of Participants with Increase in Serum Creatinine > 50% from screening visit 2.

    Measured: From baseline to 36 months post randomization

  43. Number of Participants With New Renal Artery Stenosis > 70%

    Confirmed by angiography and as determined by the angiographic core laboratory.

    Measured: From baseline to 36 months post randomization

  44. Number of Participants With Hospitalization for Hypertensive Crisis

    Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications orthe protocol

    Measured: From baseline to 36 months post randomization

Timeline

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

  1. First posted12 May 2015 (estimated)
  2. Study startJun 2015
  3. Primary completion30 Apr 2020
  4. Study completion25 Oct 2023

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02439749
Sponsor's protocol ID
SPYRAL HTN-OFF MED
Status last verified
Mar 2025
First submitted
28 Apr 2015
Last updated
28 Mar 2025
Data monitoring committee
Yes
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

  • Weber MA, Schmieder RE, Kandzari DE, Townsend RR, Mahfoud F, Tsioufis K, Kario K, Pocock S, Tatakis F, Ewen S, Choi JW, East C, Lee DP, Ma A, Cohen DL, Wilensky R, Devireddy CM, Lea JP, Schmid A, Fahy M, Bohm M. Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial. Clin Res Cardiol. 2022 Nov;111(11):1269-1275. doi: 10.1007/s00392-022-02064-5. Epub 2022 Jul 19.

    PubMed 35852582

  • Bohm M, Tsioufis K, Kandzari DE, Kario K, Weber MA, Schmieder RE, Townsend RR, Kulenthiran S, Ukena C, Pocock S, Ewen S, Weil J, Fahy M, Mahfoud F. Effect of Heart Rate on the Outcome of Renal Denervation in Patients With Uncontrolled Hypertension. J Am Coll Cardiol. 2021 Sep 7;78(10):1028-1038. doi: 10.1016/j.jacc.2021.06.044.

    PubMed 34474735

  • Mahfoud F, Townsend RR, Kandzari DE, Kario K, Schmieder RE, Tsioufis K, Pocock S, David S, Patel K, Rao A, Walton A, Bloom JE, Weber T, Suppan M, Lauder L, Cohen SA, McKenna P, Fahy M, Bohm M, Weber MA. Changes in Plasma Renin Activity After Renal Artery Sympathetic Denervation. J Am Coll Cardiol. 2021 Jun 15;77(23):2909-2919. doi: 10.1016/j.jacc.2021.04.044. Epub 2021 May 3.

    PubMed 33957242

  • Bohm M, Kario K, Kandzari DE, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Konstantinidis D, Choi JW, East C, Lee DP, Ma A, Ewen S, Cohen DL, Wilensky R, Devireddy CM, Lea J, Schmid A, Weil J, Agdirlioglu T, Reedus D, Jefferson BK, Reyes D, D'Souza R, Sharp ASP, Sharif F, Fahy M, DeBruin V, Cohen SA, Brar S, Townsend RR; SPYRAL HTN-OFF MED Pivotal Investigators. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020 May 2;395(10234):1444-1451. doi: 10.1016/S0140-6736(20)30554-7. Epub 2020 Mar 29.

    PubMed 32234534

  • Bohm M, Townsend RR, Kario K, Kandzari D, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Hickey GL, Fahy M, DeBruin V, Brar S, Pocock S. Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design. Clin Res Cardiol. 2020 Mar;109(3):289-302. doi: 10.1007/s00392-020-01595-z. Epub 2020 Feb 7.

    PubMed 32034481

  • Townsend RR, Mahfoud F, Kandzari DE, Kario K, Pocock S, Weber MA, Ewen S, Tsioufis K, Tousoulis D, Sharp ASP, Watkinson AF, Schmieder RE, Schmid A, Choi JW, East C, Walton A, Hopper I, Cohen DL, Wilensky R, Lee DP, Ma A, Devireddy CM, Lea JP, Lurz PC, Fengler K, Davies J, Chapman N, Cohen SA, DeBruin V, Fahy M, Jones DE, Rothman M, Bohm M; SPYRAL HTN-OFF MED trial investigators*. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017 Nov 11;390(10108):2160-2170. doi: 10.1016/S0140-6736(17)32281-X. Epub 2017 Aug 28.

    PubMed 28859944

  • Kandzari DE, Kario K, Mahfoud F, Cohen SA, Pilcher G, Pocock S, Townsend R, Weber MA, Bohm M. The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. Am Heart J. 2016 Jan;171(1):82-91. doi: 10.1016/j.ahj.2015.08.021. Epub 2015 Sep 11.

    PubMed 26699604

Questions about this trial

What is this clinical trial studying?

A study testing Symplicity Spyral™ multi-electrode renal denervation system in people with Hypertension and Vascular Diseases, run by Medtronic Vascular at 47 sites in 9 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 10 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Germany, United Kingdom, Canada, Greece and 4 more countries. 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. Some participants in this study may receive a placebo. 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 27 May 2021). 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?

Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events. (time frame: From baseline to 1 month post-procedure (6 months for new renal artery stenosis)). The study lists 2 primary outcomes in all. 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 NCT02439749, which also lists 8 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 28 Mar 2025.

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