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Clinical Trials/NL-OMON54832
NL-OMON54832RecruitingPhase 3

A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System* Kit, in Subjects with Hypertension. - The TARGET BP I Trial

Ablative Solutions, Inc0 sites60 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
60
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •Prior to run-in period
  • •1. Subject has provided written informed consent.
  • •2. Male or female subject, aged >=18 and <=80 years at time of enrollment.
  • •3. Subject is taking 2-5 antihypertensive medications (labeled for
  • •hypertension) at time of enrollment, and is willing to adhere to a stable (no
  • •change) medication regimen during the 4-week run-in period and 3 months
  • •post-procedure. Antihypertensive medications must be as follows:
  • •Two of the antihypertensive medications must be at least at 50% of their
  • •maximally labelled dose prior to the planned procedure.
  • •In subjects on 2 medications, one should be an ACE inhibitor or ARB, except
  • •where subjects have documented intolerance to each of these drug classes.
  • •All subjects must currently be taking, or have documentation that they failed
  • •or cannot tolerate, a diuretic.
  • •In the case of the thiazide agents hydrochlorothiazide and chlorthalidone,
  • •12.5 mg would be acceptable as a minimum dose when used in combination with one
  • •or more other antihypertensive medications.
  • •For subjects on 2 non-diuretic antihypertensive medications, because they
  • •either failed or have been unable to tolerate a diuretic, the 2 medications
  • •should consist of any of the classes of antihypertensive agents listed below,
  • •with the preferred choice of an ACE inhibitor or ARB and a CCB. In the latter
  • •case, if both ACE inhibitor/ARB and CCB are contraindicated or not tolerated,
  • •such reasons must be documented.
  • •4. Subject meets blood pressure criteria at time of enrollment and prior to the
  • •4-week run-in period: has 3 office blood pressure measurements with a mean
  • •office SBP of >=150 mmHg and <=180 mmHg, AND a mean office DBP >=90 mmHg
  • •5. Investigator judges that the subject can be managed safely during the 4-week
  • •run-in period and 3 months post-procedure period without any changes to their
  • •current antihypertensive medication regimen
  • •6. Female subjects of childbearing potential must agree to use acceptable
  • •methods of contraception, from the time of informed consent through to the last
  • •follow-up visit
  • •7. Subject agrees to have all study procedures performed and is able and
  • •willing to comply with all study follow-up visits and protocol requirements
  • •End of run-in period
  • •8. Subject has maintained the same antihypertensive medication regimen for at
  • •least 4 weeks (28 days) prior to the procedure
  • •9. Subject meets blood pressure criteria:
  • •Has 3 office blood pressure measurements with a mean office SBP of >=150 mmHg
  • •and <=180 mmHg AND mean office DBP >=90 mmHg AND
  • •Has a mean 24-hour ambulatory SBP of >=135 mmHg and <=170 mmHg with >=70% valid
  • •readings (as determined by ABPM measurement device)

Exclusion Criteria

  • •1. Subject has documented severe untreated obstructive sleep apnea
  • •2. Subject has documented diagnosis of the following causes of hypertension:
  • •Cushing*s disease or Cushing*s Syndrome, hyperaldosteronism, pheochromocytoma,
  • •thyroid and parathyroid abnormalities, or onset of hypertension prior to the
  • •3. Subject has a history of pre-eclampsia within the 5 years prior to study
  • •4. Subject has orthostatic hypotension at baseline, or documented history of
  • •orthostatic hypotension within 12 months prior to the planned procedure
  • •5. Any contraindication to the imaging as required per the protocol.
  • •6. Subject has imaging-assessed renal artery anatomy abnormalities or
  • •variations based on investigator*s evaluation of the screening images (i.e.
  • •MRA/CTA examination) meeting one of the following criteria:
  • •Main renal artery that has a diameter of <3 mm or >7 mm and length of <5 mm
  • •Accessory renal arteries with diameter <3 mm which supply >20% of the whole
  • •kidney parenchyma on that side, per the investigator*s judgment
  • •Subjects with more than one accessory renal artery per side supplying >20% of
  • •the whole kidney parenchyma.
  • •Renal artery stenosis >50% of the normal diameter segment
  • •Any renal artery abnormality or disease that, per the physician assessment,
  • •precludes the safe insertion of the guiding catheter
  • •Previous renal angioplasty associated with stenting or other implants, that,
  • •per the physician*s assessment, precludes the safe deployment of the Peregrine
  • •Catheter components in the target treatment segment of the renal artery
  • •Previous renal denervation
  • •Fibromuscular dysplasia of the renal arteries
  • •7. Subject has a renal transplant, or is known to have a non-functioning kidney
  • •or unequal renal size
  • •8. Subject has a history of nephrectomy, a single kidney or kidney tumor, or
  • •urinary tract obstruction
  • •9. Subject has a history of recurrent kidney stones, or history of kidney
  • •stones within 12 months prior to the planned procedure
  • •10. Subject has an eGFR of <=45 mL/min/1.73 m2, based on the CKD-EPI equation;
  • •or is on chronic renal replacement therapy
  • •11. Subject has nephrotic syndrome
  • •12. Subject for whom an ABPM device cannot be used due to arm size or other
  • •reasons as identified by the investigator
  • •13. Subject has any of the following conditions: severe cardiac valve stenosis,
  • •heart failure (NYHA Class III or IV), atrial fibrillation (defined as at least
  • •one documented episode in the 12 months before study entry), and known primary
  • •pulmonary hypertension (>60 mmHg pulmonary artery or right ventricular systolic
  • •14. Subject has an acute or sub-acute infection that the investigator judges
  • •would pose unacceptable procedural risks to the subject
  • •15. Subject has Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes
  • •16. Subject has a contraindication known for conventional percutaneous
  • •interventional procedures such as: intolerance for antiplatelet/anticoagulant
  • •therapy, known hypersensitivity to contrast media that cannot be adequately
  • •pre-medicated, bleeding/coagulation disorders, occlusive peripheral vascular
  • •disease that would preclude percutaneous femoral access for the procedure
  • •17. Subject has a known hypersensitivity to the neurolytic agent
  • •18. Subject has a known history of substance (drug) use or alcohol dependen

Investigators

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