A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension - CR0002

Ablative Solutions Inc.0 个研究点目标入组 1,414 人开始时间: 2024年5月24日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: Ablative Solutions Inc.
入组人数: 1,414

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

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Prior to run-in period : Subject has provided written informed consent., Prior to run-in period : Male or female subject, aged =18 and =80 years at time of enrollment., Prior to run-in period : 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., Prior to run-in period : 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., Prior to run-in period : 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., Prior to run-in period : Female subjects of childbearing potential must agree to use acceptable methods of contraception (as defined in the protocol), from the time of informed consent through to the last follow-up visit., Prior to run-in period : 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 : Subject has maintained the same antihypertensive medication regimen for at least 4 weeks (28 days) prior to the procedure., End of run-in period : 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)

排除标准

•Subject has documented severe untreated obstructive sleep apnea (apnea-hypopnea index [AHI] =30 per hour)., Subject has an eGFR of =45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy., Subject has nephrotic syndrome, Subject for whom an ABPM device cannot be used due to arm size (>42 cm arm circumference) or other reasons as identified by the investigator., 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)., Subject has an acute or sub-acute infection that the investigator judges would pose unacceptable procedural risks to the subject, Subject has Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus (defined as hemoglobin A1c [HbA1c] =9.0%)., 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 (such as bleeding diathesis, thrombocytopenia, and severe anemia). • Occlusive peripheral vascular disease that would preclude percutaneous femoral access for the procedure, Subject has a known hypersensitivity to the neurolytic agent (i.e. dehydrated alcohol)., 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 with study protocol requirements., Subject is being treated chronically (e.g. daily use) with nonsteroidal anti-inflammatory drugs (NSAIDs), immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed., 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., Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/transient ischemic attack (TIA) within 6 months prior to the planned procedure., If female, subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period., Subject has any other acute or chronic condition that the investigator believes will adversely affect the ability to interpret the data or will prevent the subject from completing the trial procedures, or has a life expectancy of <12 months., Subject is participating or has participated in another clinical study involving an investigational drug or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational drug or investigational device during the course of this study. Subjects enrolled in observational registries not involving renal denervation may still be eligible., Subject is in custody or in an institution., Subject has close affiliation with the study site or sponsor (e.g., Principal Investigator, Study Nurse, sponsor employee, close relative of study perso

研究者

发起方

Ablative Solutions Inc.

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