Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-30 @ 2:03 AM
Study NCT ID:
NCT01644604
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2012-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Denervation by MDT-2211 System in Patients With Uncontrolled 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-30', 'studyFirstSubmitDate': '2012-06-29', 'studyFirstSubmitQcDate': '2012-07-17', 'lastUpdatePostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Office Systolic Blood Pressure', 'timeFrame': 'Baseline to 6 months post-randomization'}], 'secondaryOutcomes': [{'measure': 'Incidence of Major Adverse Events (MAE)', 'timeFrame': 'Baseline through 1 month post-randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypertension', 'Vascular Diseases', 'Cardiovascular Diseases', 'Renal denervation'], 'conditions': ['Uncontrolled Hypertension']}, 'referencesModule': {'references': [{'pmid': '26558819', 'type': 'DERIVED', 'citation': 'Kario K, Bhatt DL, Brar S, Cohen SA, Fahy M, Bakris GL. Effect of Catheter-Based Renal Denervation on Morning and Nocturnal Blood Pressure: Insights From SYMPLICITY HTN-3 and SYMPLICITY HTN-Japan. Hypertension. 2015 Dec;66(6):1130-7. doi: 10.1161/HYPERTENSIONAHA.115.06260. Epub 2015 Oct 5.'}, {'pmid': '25912693', 'type': 'DERIVED', 'citation': 'Kario K, Ogawa H, Okumura K, Okura T, Saito S, Ueno T, Haskin R, Negoita M, Shimada K; SYMPLICITY HTN-Japan Investigators. SYMPLICITY HTN-Japan - First Randomized Controlled Trial of Catheter-Based Renal Denervation in Asian Patients -. Circ J. 2015;79(6):1222-9. doi: 10.1253/circj.CJ-15-0150. Epub 2015 Apr 24.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to demonstrate that the MDT-2211 renal denervation system is a safe and effective treatment for uncontrolled hypertension subjects despite treatment with 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic, as best available antihypertensive therapy', 'detailedDescription': 'The HTN-J study is a multi-center, prospective, unblinded, randomized, controlled study of the safety and effectiveness of renal denervation in subjects with uncontrolled hypertension. Bilateral renal denervation will be performed using the MDT-2211 renal denervation system - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individual is ≥ 20 and ≤ 80 years old at time of randomization.\n* Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 6 weeks prior to screening) that is expected to be maintained without changes for at least 6 months.\n* Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an average of 3 blood pressure readings measured at both an initial screening visit and a confirmatory screening visit\n* Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.\n\nExclusion Criteria highlights:\n\n* Individual has an estimated glomerular filtration rate (eGFR) of \\< 45 mL/min/1.73 m2\n* Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP \\< 135 mmHg\n* Individual has type 1 diabetes mellitus\n* Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.\n* Individual has primary pulmonary hypertension.\n* Individual is pregnant, nursing or planning to be pregnant.'}, 'identificationModule': {'nctId': 'NCT01644604', 'acronym': 'HTN-J', 'briefTitle': 'Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Vascular'}, 'officialTitle': 'The Clinical Study of Renal Denervation by MDT-2211 System in Patients With Uncontrolled Hypertension', 'orgStudyIdInfo': {'id': 'MDT2-11-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Renal denervation', 'description': 'Subjects are treated with the renal denervation procedure after randomization and are maintained on baseline anti-hypertensive medications.', 'interventionNames': ['Device: MDT-2211 Renal Denervation System']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Subjects are maintained on baseline anti-hypertensive medications'}], 'interventions': [{'name': 'MDT-2211 Renal Denervation System', 'type': 'DEVICE', 'description': 'A percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.', 'armGroupLabels': ['Renal denervation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '036-8563', 'city': 'Hirosaki-shi', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Hirosaki University School of Medicine & Hospital'}, {'zip': '260-8677', 'city': 'Chiba', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Chiba University Hospital', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '791-0295', 'city': 'Tōon', 'state': 'Ehime', 'country': 'Japan', 'facility': 'Ehime University Hospital', 'geoPoint': {'lat': 33.79427, 'lon': 132.89011}}, {'zip': '812-8582', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kyushu University Hospital', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '830-0011', 'city': 'Kurume-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kurume University Hospital'}, {'zip': '078-8510', 'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Asahikawa Medical University Hospital', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'zip': '060-8543', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Sapporo Medical University Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '665-0873', 'city': 'Takarazuka', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Higashi Takarazuka Satoh Hospital', 'geoPoint': {'lat': 34.79936, 'lon': 135.35697}}, {'zip': '305-8576', 'city': 'Tsukuba', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Tsukuba University Hospital', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'zip': '247-8533', 'city': 'Kamakura', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Shonan Kamakura General Hospital', 'geoPoint': {'lat': 35.31085, 'lon': 139.54698}}, {'zip': '230-0012', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Yokohama Tobu Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '860-8556', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Kumamoto University Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '606-8507', 'city': 'Sakyo-ku', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto University Hospital'}, {'zip': '565-0871', 'city': 'Suita-shi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka University Hospital'}, {'zip': '329-0498', 'city': 'Shimotsuke', 'state': 'Tochigi', 'country': 'Japan', 'facility': 'Jichi Medical University Hospital', 'geoPoint': {'lat': 36.41323, 'lon': 139.86622}}, {'zip': '101-8643', 'city': 'Chiyoda-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Mitsui Memorial Hospital'}, {'zip': '162-8666', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': "Tokyo Women's Medical University Hospital"}], 'overallOfficials': [{'name': 'Kazuyuki Shimada, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New Oyama Municipal Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Vascular', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}