A Study of the ReCor Medical Paradise System in Clinical Hypertension



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:4/5/2019
Start Date:March 2016
End Date:August 2021
Contact:Helen Reeve-Stoffer, PhD
Email:hreeve-stoffer@recormedical.com
Phone:+44 7947 748006

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The "RADIANCE-HTN" Study. A Study of the ReCor Medical Paradise System in Clinical Hypertension

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.

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).

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

Solo 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 < 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 ≥2 mm <4 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 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) within 3 months prior to consent

- Any history of severe cardiovascular event (myocardial infarction, CABG, acute heart
failure requiring hospitalization (NYHA III-IV) within 3 months prior to consent

- Documented confirmed episode(s) of unstable angina within 3 months prior to consent

- Documented intolerance or contraindication for any of the antihypertensive drugs
prescribed as a requirement of the study protocol

- Prescribed to any standard anti-hypertensive CV medication (other than 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 (documented 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)
We found this trial at
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Browns Mills, New Jersey 08015
Principal Investigator: Kintur Sanghvi, MD
Phone: 609-893-1200
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201 Dowman Dr
Atlanta, Georgia 30303
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Principal Investigator: Chandan Devireddy
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1720 2nd Ave S
Birmingham, Alabama 35233
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185 Cambridge Street
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Naomi Fisher, MD
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Christopher Bajzer, MD
Phone: 216-444-6321
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Florian Radar
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Josephine Abraham, MD
Phone: 801-585-1897
University of Utah Research is a major component in the life of the U benefiting...
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10 Avenue Hippocrate
Brussels, 1200
Principal Investigator: Alexandre Persu, MD, PhD
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Chapel Hill, North Carolina 27599
Principal Investigator: George Stouffer
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Tom Todoran, MD
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Cleveland, Ohio 44012
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Gainesville, Florida 32605
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8111 South Emerson Avenue
Indianapolis, Indiana 46237
Principal Investigator: Atul Chugh, MD
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Lexington, Kentucky 40503
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Los Angeles, California 90027
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Minneapolis, Minnesota 55407
Principal Investigator: Yale L Wang, MD
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Pete Fong, MD
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Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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New York, New York 10022
Principal Investigator: Ajay Kirtane, MD
Phone: 212-342-3486
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550 1st Ave
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(212) 263-7300
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3301 Lancaster Avenue
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3451 Walnut St
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1 (215) 898-5000
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Plano, Texas 75093
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Reno, Nevada 89502
Principal Investigator: Michael Bloch
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Sacramento, California 95816
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Springfield, Illinois 62794
Principal Investigator: John Flack, MD
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Stamford, Connecticut 06904
Principal Investigator: David Hsi, MD
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Stanford, California 94305
Principal Investigator: David Lee, MD
Phone: 650-721-5540
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