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 个研究点目标入组 1,500 人开始时间: 2020年11月24日最近更新: 2024年7月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Ablative Solutions, Inc
入组人数: 1,500

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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.
•Note: The following classes of antihypertensive agents that would count towards the minimum number of agents are: ACE inhibitors, ARBs, CCBs, thiazide diuretics, loop diuretics, aldosterone antagonists, beta-blockers, centrally active agents, alpha receptor blockers, direct vasodilators, direct renin inhibitors and hydralazine.
•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)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 860
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 640

排除标准

•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 age of 18
•3. Subject has a history of pre-eclampsia within the 5 years prior to
•study entry
•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 (New York Heart Association [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 pressure).
•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 mellitus
•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 dependence, or lacks the ability to comprehend or follow instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply wi

研究者

发起方

Ablative Solutions, Inc

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