Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-02-20 @ 12:36 PM
Study NCT ID:
NCT03614260
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-04
First Post:
2018-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075222', 'term': 'Essential Hypertension'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-12-14', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2018-07-30', 'studyFirstSubmitQcDate': '2018-07-30', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Major Adverse Events (MAE)', 'timeFrame': 'From baseline to 30 days post-procedure'}, {'measure': 'Change in average daytime ambulatory systolic BP', 'timeFrame': 'From baseline to 2 months post-procedure'}], 'secondaryOutcomes': [{'measure': 'Change in average 24-hr ambulatory systolic BP', 'timeFrame': 'From baseline to 2 months post-procedure'}, {'measure': 'Change in average office systolic BP', 'timeFrame': 'From baseline to 2 months post-procedure'}, {'measure': 'Change in average home systolic BP', 'timeFrame': 'From baseline to 2 months post-procedure'}, {'measure': 'Change in average daytime ambulatory diastolic BP', 'timeFrame': 'From baseline to 2 months post-procedure'}, {'measure': 'Change in average 24-hr ambulatory diastolic BP', 'timeFrame': 'From baseline to 2 months post-procedure'}, {'measure': 'Change in average office diastolic BP', 'timeFrame': 'From baseline to 2 months post-procedure'}, {'measure': 'Change in average home diastolic BP', 'timeFrame': 'From baseline to 2 months post-procedure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Denervation', 'Resistant Hypertension', 'Essential Hypertension', 'Uncontrolled Hypertension'], 'conditions': ['Hypertension', 'Vascular Diseases', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '36853250', 'type': 'RESULT', 'citation': 'Azizi M, Saxena M, Wang Y, Jenkins JS, Devireddy C, Rader F, Fisher NDL, Schmieder RE, Mahfoud F, Lindsey J, Sanghvi K, Todoran TM, Pacella J, Flack J, Daemen J, Sharp ASP, Lurz P, Bloch MJ, Weber MA, Lobo MD, Basile J, Claude L, Reeve-Stoffer H, McClure CK, Kirtane AJ; RADIANCE II Investigators and Collaborators. Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial. JAMA. 2023 Feb 28;329(8):651-661. doi: 10.1001/jama.2023.0713.'}, {'pmid': '37883784', 'type': 'DERIVED', 'citation': 'Azizi M, Sharp ASP, Fisher NDL, Weber MA, Lobo MD, Daemen J, Lurz P, Mahfoud F, Schmieder RE, Basile J, Bloch MJ, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Claude L, Augustin DA, McClure CK, Kirtane AJ; RADIANCE Investigators. Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program. Circulation. 2024 Mar 5;149(10):747-759. doi: 10.1161/CIRCULATIONAHA.123.066941. Epub 2023 Oct 26.'}, {'pmid': '36853627', 'type': 'DERIVED', 'citation': 'Kirtane AJ, Sharp ASP, Mahfoud F, Fisher NDL, Schmieder RE, Daemen J, Lobo MD, Lurz P, Basile J, Bloch MJ, Weber MA, Saxena M, Wang Y, Sanghvi K, Jenkins JS, Devireddy C, Rader F, Gosse P, Sapoval M, Barman NC, Claude L, Augustin D, Thackeray L, Mullin CM, Azizi M; RADIANCE Investigators and Collaborators. Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials. JAMA Cardiol. 2023 May 1;8(5):464-473. doi: 10.1001/jamacardio.2023.0338.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the RADIANCE II Pivotal study is to demonstrate the effectiveness and safety of the Paradise System in subjects with Stage 2 hypertension on 0-2 medications at the time of consent. Prior to randomization, subjects will be hypertensive in the absence of hypertension medication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously or currently prescribed antihypertensive therapy\n* Average office BP ≥ 140/90 mmHg \\<180/120 mmHg while stable for at least 4 weeks on 0-2 classes of antihypertensive medication\n* Documented daytime ABP ≥ 135/85 mmHg and \\< 170/105 mmHg after 4-week washout/run-in period\n\nExclusion Criteria:\n\n* Lacks appropriate renal artery anatomy for treatment\n* Known, uncorrected causes of secondary hypertension other than sleep apnea\n* Type I diabetes mellitus or uncontrolled Type II diabetes\n* eGFR of \\<40\n* Brachial circumference ≥ 42 cm\n* Any history of cerebrovascular event or severe cardiovascular event, or history of stable or unstable angina within 12 months prior to consent\n* Repeat (\\>1) hospitalization for hypertensive crisis within 12 months prior to screening period, or any hospitalization for hypertensive crisis within 3 months prior to screening period\n* Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea\n* Primary pulmonary hypertension\n* Night shift workers\n* Pregnant, nursing or planning to become pregnant'}, 'identificationModule': {'nctId': 'NCT03614260', 'acronym': 'RADIANCE-II', 'briefTitle': 'The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'ReCor Medical, Inc.'}, 'officialTitle': 'The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension', 'orgStudyIdInfo': {'id': 'RADIANCE II Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Renal Denervation', 'description': 'Renal Angiogram and Renal Denervation (Paradise Renal Denervation System)', 'interventionNames': ['Device: Paradise Renal Denervation System']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Control', 'description': 'Renal Angiogram', 'interventionNames': ['Procedure: Renal Angiogram']}], 'interventions': [{'name': 'Paradise Renal Denervation System', 'type': 'DEVICE', 'otherNames': ['Renal Angiogram', 'Renal Denervation'], 'description': 'Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.', 'armGroupLabels': ['Renal Denervation']}, {'name': 'Renal Angiogram', 'type': 'PROCEDURE', 'description': 'Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.', 'armGroupLabels': ['Sham Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cardiology PC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '940048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06610', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bridgeport Hospital', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '06904', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Stamford Hospital', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Washington', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32605', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'The Cardiac and Vascular Institute', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital Midtown', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62794', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Heart and Vascular Institute', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "The Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49684', 'city': 'Traverse City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Munson Medical Center', 'geoPoint': {'lat': 44.76306, 'lon': -85.62063}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Institute Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Health System", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Renown Regional Medical Center', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '08015', 'city': 'Browns Mills', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Deborah Heart & Lung Center', 'geoPoint': {'lat': 39.97261, 'lon': -74.58293}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center/NYPH', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health Inc.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The University of Tennessee Health Science Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Centre Hospitalier Universitaire Saint-Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Saint André', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges-Pompidou (HEGP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'D-91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'University Clinic Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': 'D-66421', 'city': 'Homburg', 'country': 'Germany', 'facility': 'University Clinic of Saarland - Homburg', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'zip': '76133', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Klinikum Karlsruhe GmbH', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': 'D-78464', 'city': 'Konstanz', 'country': 'Germany', 'facility': 'Klinikum Konstanz', 'geoPoint': {'lat': 47.66033, 'lon': 9.17582}}, {'zip': 'D-04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig GmbH', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': 'D-23560', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Sana Kliniken Lübeck GmbH', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': 'H91 YR71', 'city': 'Galway', 'country': 'Ireland', 'facility': 'University Hospital Galway', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hôpitaux Universitaires Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': 'SS16 5NL', 'city': 'Basildon', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'The Cardiothoracic Centre Basildon University Hospital', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'University Hospitals Dorset NHS Foundation Trust', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'CT1 3NG', 'city': 'Canterbury', 'country': 'United Kingdom', 'facility': 'Kent & Canterbury Hospital', 'geoPoint': {'lat': 51.27904, 'lon': 1.07992}}, {'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Hospital Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'EC1A 7BE', 'city': 'London', 'country': 'United Kingdom', 'facility': "St Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Freeman Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Ajay Kirtane, MD, SM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation'}, {'name': 'Prof. Michel Azizi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Vascular Medicine, Hypertension Dept. and Clinical Investigation Center, Hôpital Européen Georges Pompidou'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ReCor Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}