Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-30 @ 12:49 AM
Study NCT ID:
NCT01682057
Status:
COMPLETED
Last Update Posted:
2015-01-29
First Post:
2012-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Study to Evaluate the ROX Anastomotic Coupler System (ACS) In Patients With Severe Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-27', 'studyFirstSubmitDate': '2012-09-05', 'studyFirstSubmitQcDate': '2012-09-07', 'lastUpdatePostDateStruct': {'date': '2015-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in mean office SBP', 'timeFrame': 'Baseline, 6 months', 'description': 'Change in mean office SBP at six months as compared to Baseline'}], 'secondaryOutcomes': [{'measure': 'Change in mean office DBP', 'timeFrame': 'Change in mean office DBP six months as compared to Baseline', 'description': 'Change in mean office DBP at six months as compared to Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['High Blood Pressure', 'Hypertension', 'Resistant Hypertension'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and performance of the ROX Anastomotic Coupler System (ACS) in patients with severe hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of severe hypertension must be made on the basis of current findings, medical history, and physical examination\n\nExclusion Criteria:\n\n* Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study."}, 'identificationModule': {'nctId': 'NCT01682057', 'briefTitle': 'A Multicenter Study to Evaluate the ROX Anastomotic Coupler System (ACS) In Patients With Severe Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'ROX Medical, Inc.'}, 'officialTitle': 'A Prospective, Non-Randomized, Open Label, Multi-Center Study to Evaluate the ROX Anastomotic Coupler System (ACS) in Patients With Severe Hypertension', 'orgStudyIdInfo': {'id': 'RH-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'ROX Anastomic Coupler System (ACS) + continuing standard antihypertensive medications', 'interventionNames': ['Device: ROX ANASTOMOTIC COUPLER SYSTEM (ACS)']}], 'interventions': [{'name': 'ROX ANASTOMOTIC COUPLER SYSTEM (ACS)', 'type': 'DEVICE', 'description': 'The ROX Anastomic Coupler (ACS) will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).', 'armGroupLabels': ['Group A']}, {'name': 'ROX Anastomotic Coupler System (ACS)', 'type': 'DEVICE', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ROX Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}