Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-26 @ 1:43 PM
Study NCT ID:
NCT01939392
Status:
WITHDRAWN
Last Update Posted:
2015-08-18
First Post:
2013-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Renal Sympathetic Denervation for Resistant Hypertension II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-14', 'studyFirstSubmitDate': '2013-09-06', 'studyFirstSubmitQcDate': '2013-09-06', 'lastUpdatePostDateStruct': {'date': '2015-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse event (MAE) rate through 30 days post randomization', 'timeFrame': '30 days'}, {'measure': 'Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Acute Procedural Safety', 'timeFrame': '30 days'}, {'measure': 'Chronic procedural safety', 'timeFrame': '6 months'}, {'measure': 'Reduction in SBP by >10 mmHg at 6 months', 'timeFrame': '6 months'}, {'measure': 'Changes in office SBP and diastolic blood pressure (DBP) from baseline to follow-up visits', 'timeFrame': '6, 12, 24, and 36 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Resistant hypertension', 'Uncontrolled hypertension', 'Renal artery ablation'], 'conditions': ['Resistant Hypertension', 'Uncontrolled Hypertension', 'Renal Artery Ablation']}, 'descriptionModule': {'briefSummary': 'This is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the OneShot Renal Denervation System in patients with uncontrolled hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individual has a systolic blood pressure ≥ 160 mmHg based on an average of three office blood pressure readings.\n* Stable drug regimen including three or more anti-hypertensive medications including a diuretic\n\nExclusion Criteria:\n\n* Renal anatomy unsuitable for treatment\n* Presence of hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous\n* Patient has Type I diabetes\n* Has scheduled or planned surgery within the next 6 months\n* Individual is pregnant nursing or plans to be pregnant'}, 'identificationModule': {'nctId': 'NCT01939392', 'acronym': 'RAPID II', 'briefTitle': 'Rapid Renal Sympathetic Denervation for Resistant Hypertension II', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Endovascular'}, 'officialTitle': 'Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot Renal Denervation System II', 'orgStudyIdInfo': {'id': 'CP-1003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Renal Denervation', 'description': 'Subjects randomized to the Renal Denervation arm will receive bilateral renal ablation with the OneShot system and be maintained on antihypertensive medication.', 'interventionNames': ['Device: Renal Denervation (OneShot™ Renal Denervation System)']}, {'type': 'NO_INTERVENTION', 'label': 'Optimal Medical Therapy', 'description': 'Subjects randomized to the control arm will be maintained on antihypertensive medications.'}], 'interventions': [{'name': 'Renal Denervation (OneShot™ Renal Denervation System)', 'type': 'DEVICE', 'otherNames': ['OneShot Ablation system', 'Catheter-based renal denervation'], 'armGroupLabels': ['Renal Denervation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'country': 'Italy', 'facility': 'Hospital San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Dierk Scheinert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Park-Krankenhaus Liepzig'}, {'name': 'Guiseppe Mancia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universita Minano-Bicocca, Ospedale San Gerardo di Monza'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Endovascular', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}