2024-512525-83-00招募中3 期
A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension
Ablative Solutions Inc., Ablative Solutions Inc.33 个研究点 分布在 7 个国家目标入组 476 人开始时间: 2024年6月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 476
- 试验地点
- 33
- 主要终点
- Change in mean 24-hour ambulatory SBP from baseline to 3 months post-procedure.
研究概览
简要总结
To evaluate the efficacy of renal denervation by alcohol-mediated neurolysis using the Peregrine Kits in uncontrolled hypertensive subjects when used in combination with antihypertensive medications.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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), or 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
- •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 personnel or sponsor employee).
- •Subject has a history of pre-eclampsia within the 5 years prior to study entry.
- •Subject has orthostatic hypotension at baseline, or documented history of orthostatic hypotension within 12 months prior to the planned procedure, defined as a drop in blood pressure that is >20 mmHg in SBP and/or >10 mmHg in DBP within 3 minutes upon standing from sitting or from a lying down face-up (supine) position.
- •Any contraindication to the imaging as required per the protocol.
- •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 <3mm, 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
- •Subject has a renal transplant, or is known to have a non-functioning kidney or unequal renal size (>2 cm difference in renal length between kidneys associated with a chronic kidney disease or a deterioration of the kidney function).
- •Subject has a history of nephrectomy, a single kidney or kidney tumor, or urinary tract obstruction (with potential for hydronephrosis). Note: Simple renal cysts are not an exclusion.
- •Subject has a history of recurrent (>1 episode) kidney stones, or history of kidney stones within 12 months prior to the planned procedure.
结局指标
主要结局
Change in mean 24-hour ambulatory SBP from baseline to 3 months post-procedure.
Change in mean 24-hour ambulatory SBP from baseline to 3 months post-procedure.
次要结局
- Change in mean office SBP from baseline to 3 months post-procedure.
- Change in mean office SBP from baseline to 4 weeks post-procedure.
- Change in mean 24-hour ambulatory SBP from baseline to 6 months post-procedure.
- Change in mean office SBP from baseline to 6 months post-procedure.
- Changes (decreases or increases) in antihypertensive medication regimen from procedure to 6 months post-procedure (titrated according to standardized formula to maintain a target office SBP of <140 mmHg and ≥90 mmHg)
- Change in mean daytime (07:00 to 21:59) ambulatory SBP from baseline to 3 months post-procedure.
- Change in mean daytime ambulatory SBP from baseline to 6 months post-procedure.
- Change in mean office DBP from baseline to 3 months and then 6 months post-procedure.
- Change in mean 24-hour ambulatory DBP from baseline to 3 months and then 6 months post-procedure.
- Change in mean daytime ambulatory DBP from baseline to 3 months and then 6 months post-procedure.
- Changes (decreases or increases) in antihypertensive medication regimen from 3 months to 6 months post-procedure (titrated according to standardized formula to maintain a target office SBP of <140 mmHg and ≥90 mmHg).
- Change in mean nighttime (22:00 to 06:59) ambulatory SBP from baseline to 3 months and then 6 months post-procedure
- Change in mean nighttime ambulatory DBP from baseline to 3 months and then 6 months post-procedure.
- ABPM Responders, defined as the proportion of subjects with a drop of ≥5 mmHg in 24-hour ambulatory SBP at 3 months compared with baseline
- Office BP Responders, defined as the proportion of subjects with a drop of ≥10 mmHg in office SBP at 3 months compared with baseline
- Reduction of both office SBP and DBP to normal (<140/90 mmHg) at 3, 6 and 12 months as compared to baseline.
- Changes (any decrease or increase) in antihypertensive medication regimen from procedure to 3 months post-procedure.
- Major adverse events (MAEs) through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).
- MAEs at 3, 6, and 12 months and 2 and 3 years.
- Renal artery stenosis >60% diameter as indicated by imaging at 6 months.
- Change in eGFR from baseline to 3 months and 6 months post-procedure.
- Decreases in eGFR >25% from baseline to 3 months and 6 months post-procedure
- Rate of AEs (serious and non-serious), peri-procedurally, at discharge, and at each of the follow-up time points.
- Device success (defined as the ability to insert the Peregrine Catheters into the lumen of the renal artery [target vessel], deploy the guide tubes inside the renal artery, deploy the needles through the arterial wall, deliver the intended dose of alcohol, retract the needles and the guide tubes back in the catheter, and remove the catheter from the access site without any related complications or events).
- Procedure success (defined as device success with freedom from peri-procedural MAEs).
研究者
Kristine Canavan
Scientific
Ablative Solutions Inc.
研究点 (33)
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