NCT02649426Active, not recruitingNot Applicable
The "RADIANCE-HTN" Study. A Study of the ReCor Medical Paradise System in Clinical Hypertension
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ReCor Medical, Inc.
- Enrollment
- 282
- Locations
- 95
- Primary Endpoint
- Trio Cohort - Median Change in Daytime Ambulatory Systolic BP
Study Overview
Brief Summary
RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.
Detailed Description
Subjects with essential hypertension controlled on 1 or 2 antihypertensive medications or uncontrolled on 0-2 antihypertensive medications will be included in the RADIANCE Solo cohort while subjects with treatment resistant hypertension on a minimum of 3 antihypertensive medications will be included in the RADIANCE Trio cohort. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication (SOLO) or despite the presence of a stabilized, single pill, triple, fixed dose antihypertensive medication regimen (TRIO).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •TRIO and SOLO Inclusion Criteria:
- •Appropriately signed and dated informed consent
- •Age ≥18 and ≤75 years at time of consent
- •Documented history of essential hypertension
- •SOLO Cohort only: Either an average seated office BP < 180/110 mmHg at screening visit while on a stable regimen of 1 or 2 antihypertensive medications for at least 4 weeks prior to consent or an average seated office BP ≥ 140/90 mmHg <180/110 mmHg despite lifestyle measures on no antihypertensive medications
- •TRIO Cohort only: Average seated office BP ≥ 140/90 mmHg at screening visit while on a stable regimen of at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent
- •Documented daytime ABP ≥ 135/85 mmHg and < 170/105 mmHg after 4-week washout/run-in period (SOLO cohort) or after 4-week stabilization period (TRIO cohort)
- •Suitable renal anatomy compatible with the renal denervation procedure and documented by renal CTA or MRA of good quality performed within one year prior to consent (a CTA or MRA will be obtained in patients without a recent (≤1 year) renal imaging)
- •Able and willing to comply with all study procedures
Exclusion Criteria
- •Renal artery anatomy on either side, ineligible for treatment including:
- •Main renal artery diameter < 4 mm and > 8 mm
- •Main renal artery length < 25 mm
- •A single functioning kidney
- •Presence of abnormal kidney (or secreting adrenal) tumors
- •Renal artery with aneurysm
- •Pre-existing renal stent or history of renal artery angioplasty
- •Prior renal denervation procedure
- •Fibromuscular disease of the renal arteries
- •Presence of renal artery stenosis of any origin ≥ 30%
- •Accessory arteries with diameter ≥ 2mm <4 mm and > 8 mm*
- •Evidence of active infection within 7 days of procedure
- •Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
- •Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%)
- •Documented history of chronic active inflammatory bowel disorders such as Chrohn's disease or ulcerative colitis
- •eGFR of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
- •Brachial circumference ≥ 42 cm
- •Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident)
- •Any history of severe cardiovascular event (myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV)
- •Documented confirmed episode(s) of stable or unstable angina
- •Documented repeat (>1) hospitalization for hypertensive crisis within the prior 12 months
- •Prescribed to any standard antihypertensive of cardiovascular medication (e.g. beta blockers) for other chronic conditions (e.g. ischemic heart disease) such that discontinuation might pose serious risk to health
- •Documented history of persistent or permanent atrial tachyarrhythmia
- •Active implantable medical device (e.g. ICD or CRT-D; neuromodulator/spinal stimulator; baroreflex stimulator)
- •Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
- •Primary pulmonary hypertension
- •Documented contraindication or allergy to contrast medium not amenable to treatment
- •Limited life expectancy of < 1 year at the discretion of the Investigator
- •Any known, unresolved history of drug use or alcohol dependency, 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 or whose participation may result in data analysis confounders (e.g. night shift workers)
- •Pregnant, nursing or planning to become pregnant (negative pregnancy test required, documented within a maximum of 7 days prior to procedure for all women of child bearing potential. Documentation of effective contraception is also required for women of child bearing potential) Concurrent enrollment in any other investigational drug or device trial (participation in non-interventional Registries is acceptable)
- •TRIO Exclusion Criteria
- •Renal artery anatomy on either side, ineligible for treatment including:
- •Main renal artery diameter < 3.5 mm and > 8 mm
- •Main renal artery length < 20 mm
- •A single functioning kidney
- •Presence of abnormal kidney tumors
- •Renal artery with aneurysm
- •Pre-existing renal stent or history of renal artery angioplasty
- •Pre-existing aortic stent or history of aortic aneurysm
- •Prior renal denervation procedure
- •Fibromuscular disease of the renal arteries
- •Presence of renal artery stenosis of any origin ≥ 30%
- •Accessory arteries with diameter ≥2 mm <3.5 mm and > 8 mm*
- •Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter
- •Evidence of active infection within 7 days of procedure
- •Secondary hypertension not including sleep apnea (documented through clinical work up within the 12 months prior to consent- see protocol body for details)
- •Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%)
- •Documented history of chronic active inflammatory bowel disorders such as Crohn's disease or ulcerative colitis
- •eGFR of <40 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula)
- •Brachial circumference ≥ 42 cm
- +16 more not shown
Arms & Interventions
Ultrasound Renal Denervation
Experimental
Subjects in the TRIO or SOLO cohorts that are randomized to treatment, will receive renal denervation following a renal angiogram
Intervention: The Paradise® Renal Denervation Ultrasound System (Device)
Sham Procedure
Sham Comparator
For subjects in TRIO or SOLO cohorts that randomize to the sham procedure, the diagnostic renal angiogram intervention will be considered the sham procedure.
Intervention: Sham Procedure (Device)
Outcomes
Primary Outcomes
Trio Cohort - Median Change in Daytime Ambulatory Systolic BP
Time Frame: from baseline to 2 months post procedure
Median change in daytime ambulatory systolic BP of the Trio cohort
Solo Cohort - Mean Difference in Average Daytime Ambulatory Systolic BP
Time Frame: from baseline to 2 months post procedure
Mean difference in average daytime ambulatory systolic BP of the Solo cohort
Secondary Outcomes
- Reduction in Average 24-hr/Night-time Ambulatory Systolic BP(from baseline to 2 months post procedure)
- Hypertensive or Hypotensive Emergency Resulting in Hospitalization(up to 36 months)
- Hospitalization for Heart Failure(from baseline to 36 months post-procedure)
- Acute Myocardial Infarction(from baseline to 36 months post-procedure)
- Renal Artery or Vascular Complications Requiring Intervention(from baseline to 36 months post-procedure)
- Acute Renal Injury(from baseline to 1 month and 36 months post-procedure)
- Stroke, Transient Ischemic Attack, Cerebrovascular Accident(from baseline to 36 months post-procedure)
- Reduction in Average Daytime/24-hr/Night-time Diastolic BP(from baseline to 2 months post procedure)
- Significant (>50%) and Severe (>75%) New Onset Renal Stenosis(from baseline to 6, 12, 24 and 36 months post-procedure)
- Major Access Site Complications(from baseline to 1 month and 36 months post-procedure)
- All-cause Mortality(from baseline to 36 months post-procedure)
- End Stage Renal Disease(from baseline to 36 months post-procedure)
- Significant Embolic Events Resulting in End Organ Damage(from baseline to 1 month and 36 months post-procedure)
- Procedure Related Pain Lasting > 2 Days(from baseline to 1 month and 36 months post-procedure)
Investigators
Study Sites (95)
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