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

Use our guide to learn which trials are right for you!

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
29
sites
Los Angeles, California 90027
Principal Investigator: Somjot Brar
Phone: 323-783-5220
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Chandan Devireddy
Phone: 404-686-7468
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: David Calhoun, MD
Phone: 205-975-4338
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-1372
?
mi
from
Boston, MA
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Naomi Fisher, MD
Phone: 617-732-7381
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
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...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Florian Radar
Phone: 424-315-2501
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
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...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Browns Mills, New Jersey 08015
Principal Investigator: Kintur Sanghvi, MD
Phone: 609-893-1200
?
mi
from
Browns Mills, NJ
Click here to add this to my saved trials
10 Avenue Hippocrate
Brussels, 1200
Principal Investigator: Alexandre Persu, MD, PhD
?
mi
from
Brussels,
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
Principal Investigator: George Stouffer
Phone: 919-962-4896
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Tom Todoran, MD
Phone: 843-876-5009
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Cleveland, Ohio 44012
Phone: 216-983-4724
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Gainesville, Florida 32605
Principal Investigator: Matheen Khuddus, MD
Phone: 352-244-0208
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
8111 South Emerson Avenue
Indianapolis, Indiana 46237
Principal Investigator: Atul Chugh, MD
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Lexington, Kentucky 40503
Principal Investigator: Michael Jones, MD
Phone: 859-260-6172
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Minneapolis, Minnesota 55407
Principal Investigator: Yale L Wang, MD
Phone: 612-863-6051
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Pete Fong, MD
Phone: 615-343-9071
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Orleans, Louisiana
Phone: 504-842-6832
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10022
Principal Investigator: Ajay Kirtane, MD
Phone: 212-342-3486
?
mi
from
New York, NY
Click here to add this to my saved trials
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Sripal Bangalore
Phone: 646-501-2897
New York University School of Medicine NYU School of Medicine has a proud history that...
?
mi
from
New York, NY
Click here to add this to my saved trials
3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
Principal Investigator: Jessie Goldman
Phone: 215-762-3369
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Debbie Cohen, MD
Phone: 216-615-0773
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Plano, Texas 75093
Principal Investigator: Srini Potluri, MD
Phone: 469-814-4717
?
mi
from
Plano, TX
Click here to add this to my saved trials
Reno, Nevada 89502
Principal Investigator: Michael Bloch
Phone: 775-982-2217
?
mi
from
Reno, NV
Click here to add this to my saved trials
Sacramento, California 95816
Principal Investigator: Pei-Hsiu Huang, MD
Phone: 916-887-4173
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
Springfield, Illinois 62794
Principal Investigator: John Flack, MD
Phone: 217-545-4402
?
mi
from
Springfield, IL
Click here to add this to my saved trials
Stamford, Connecticut 06904
Principal Investigator: David Hsi, MD
Phone: 203-276-7880
?
mi
from
Stamford, CT
Click here to add this to my saved trials
Stanford, California 94305
Principal Investigator: David Lee, MD
Phone: 650-721-5540
?
mi
from
Stanford, CA
Click here to add this to my saved trials