Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT05017935
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2021-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RADIANCE Continued Access Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'C563514', 'term': 'Hypertension Resistant to Conventional Therapy'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075222', 'term': 'Essential Hypertension'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-13', 'studyFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2021-08-17', 'lastUpdatePostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': 'From baseline to 60 months'}, {'measure': 'Change in average daytime ambulatory systolic BP', 'timeFrame': 'From baseline to 2 months post procedure'}], 'secondaryOutcomes': [{'measure': 'Change in average 24-hr/night-time ambulatory systolic BP', 'timeFrame': 'From baseline to 2 months post procedure'}, {'measure': 'Change in average daytime/24-hr/night-time ambulatory systolic BP', 'timeFrame': 'From Baseline to Months 6 and 12 post procedure'}, {'measure': 'Change in average office systolic/diastolic BP', 'timeFrame': 'From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure'}, {'measure': 'Change in average home systolic/diastolic BP', 'timeFrame': 'From Baseline to Months 2, 6, 12, 24, 36, 48, and 60 post procedure'}, {'measure': 'Change in average 24-hr/night-time ambulatory diastolic BP', 'timeFrame': 'From baseline to Months 2, 6, and 12 post procedure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Blood Pressure', 'Uncontrolled Hypertension', 'Essential Hypertension', 'Resistant Hypertension', 'Denervation'], 'conditions': ['Hypertension', 'Hypertension, Resistant to Conventional Therapy', 'Vascular Diseases', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '34010611', 'type': 'BACKGROUND', 'citation': 'Azizi M, Sanghvi K, Saxena M, Gosse P, Reilly JP, Levy T, Rump LC, Persu A, Basile J, Bloch MJ, Daemen J, Lobo MD, Mahfoud F, Schmieder RE, Sharp ASP, Weber MA, Sapoval M, Fong P, Pathak A, Lantelme P, Hsi D, Bangalore S, Witkowski A, Weil J, Kably B, Barman NC, Reeve-Stoffer H, Coleman L, McClure CK, Kirtane AJ; RADIANCE-HTN investigators. Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial. Lancet. 2021 Jun 26;397(10293):2476-2486. doi: 10.1016/S0140-6736(21)00788-1. Epub 2021 May 16.'}], 'seeAlsoLinks': [{'url': 'https://www.recormedical.com/', 'label': 'ReCor Medical company website'}, {'url': 'https://www.highbptrial.com', 'label': 'Study eligibility questionnaire; study summary and information'}]}, 'descriptionModule': {'briefSummary': 'RADIANCE CAP is a non-randomized study designed to allow for continued access to ultrasound renal denervation therapy via the Paradise System, and to allow for the on-going collection of safety and effectiveness data in subjects with uncontrolled hypertension despite the prescription of antihypertensive medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Average office BP ≥140/90 mmHg at screening visit despite taking stables doses of antihypertensive medications for at least 4 weeks prior to consent\n* Documented daytime ABP ≥135/85 mmHg following 4 week run-in/standardization period on antihypertensive medication regimen\n\nExclusion Criteria:\n\n* Renal artery anatomy ineligible for treatment\n* Secondary hypertension not including sleep apnea\n* Type I diabetes mellitus or uncontrolled Type II diabetes (defined as plasma HbA1c ≥9.0%)\n* eGFR \\<40\n* Brachial circumference ≥42 cm\n* Any history of cerebrovascular event or severe cardiovascular event within 3 months prior to consent\n* Documented repeat (\\>1) hospitalization for hypertensive crisis within 3 months prior to consent\n* Documented confirmed episode(s) of unstable angina within 3 months prior to consent\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': 'NCT05017935', 'acronym': 'RADIANCE CAP', 'briefTitle': 'RADIANCE Continued Access Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'ReCor Medical, Inc.'}, 'officialTitle': 'RADIANCE Continued Access Protocol (RADIANCE CAP): A Study of the ReCor Medical Paradise System in Clinical Hypertension', 'orgStudyIdInfo': {'id': 'CLN-0932'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Renal Denervation', 'interventionNames': ['Device: Renal Denervation']}], 'interventions': [{'name': 'Renal Denervation', 'type': 'DEVICE', 'description': 'Renal angiogram and renal denervation (Paradise ultrasound Renal Denervation System)', 'armGroupLabels': ['Renal Denervation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Cardiovascular Institute of San Diego', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Health', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Heart Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '06610', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bridgeport Hospital', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}, {'zip': '32604', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'The Cardiac and Vascular Institute', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Hospital of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United 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'state': 'Iowa', 'country': 'United States', 'facility': 'UnityPoint Health-Des Moines', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Lifebridge Health', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21804', 'city': 'Salisbury', 'state': 'Maryland', 'country': 'United States', 'facility': 'Tidal Health', 'geoPoint': {'lat': 38.36067, 'lon': -75.59937}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "The Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 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'country': 'United States', 'facility': 'NJ Heart & Vascular', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': '001501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Hospital - Long Island', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'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': '11794-8167', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University Hospital', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27599-7075', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 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'country': 'United States', 'facility': 'The University of Texas Health Sciences Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '79430', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Sciences Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Sciences Center, San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White Research Institute', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Health Services', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Naomi Fisher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital/Harvard Medical School"}, {'name': 'Ajay Kirtane, MD, SM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University Medical Center/NYPH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ReCor Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}