Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-01-23 @ 3:14 AM
Study NCT ID:
NCT01789918
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2013-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-05', 'studyFirstSubmitDate': '2013-02-08', 'studyFirstSubmitQcDate': '2013-02-08', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in EQ-5D Quality of Life score', 'timeFrame': '12 months', 'description': 'Change from baseline in EQ-5D Quality of Life score'}, {'measure': 'Change from baseline in cardiac function', 'timeFrame': '12 months', 'description': 'Change from baseline in cardiac function'}], 'primaryOutcomes': [{'measure': 'Percentage of patients with device- or procedure-related adverse events', 'timeFrame': '12 months', 'description': 'Anticipated adverse events include:\n\n* Access site and access-related vascular injury\n* Renal artery complications, including: stenosis, aneurysm, dissection, and perforation\n* Renal complications, including: renal infarction, acute kidney injury, and renal failure\n* Arterial and venous thromboembolic events, including: myocardial infarction, stroke or transient ischemic attack, pulmonary embolism, and deep vein thrombosis\n* Systemic effects, including: allergic reaction and infection'}, {'measure': 'Change from baseline in systolic blood pressure', 'timeFrame': '12 months', 'description': 'Change from baseline in systolic blood pressure'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in diastolic blood pressure', 'timeFrame': '12 months', 'description': 'Change from baseline in diastolic blood pressure'}, {'measure': 'Change from baseline in anti-hypertensive medication intake', 'timeFrame': '12 months', 'description': 'Change from baseline in anti-hypertensive medication intake'}, {'measure': 'Changes from baseline in pulse pressure and nocturnal dipping', 'timeFrame': '12 months', 'description': 'Changes from baseline in pulse pressure and nocturnal dipping'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Blood pressure', 'Renal denervation'], 'conditions': ['Resistant Hypertension']}, 'descriptionModule': {'briefSummary': 'The ACHIEVE study is a single-arm, open-label, prospective, post-market follow-up study to include up to one hundred (100) eligible patients as defined within the clinical investigational plan, with a twelve month follow-up period. The ACHIEVE study was originally designed in accordance with the 2007 ESH ESC guidelines for resistant hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resistant hypertension, as defined in the 2007 ESH-ESC guidelines\n* 18 years of age or older\n* Negative pregnancy test for female patients of childbearing potential\n* Willing and able to comply with follow-up requirements\n* Signed informed consent\n\nExclusion Criteria:\n\n* Secondary hypertension\n* Main renal arteries length \\< 20 mm\n* Main renal arteries diameter \\< 4 mm\n* Renal artery stenosis\n* Iliac/femoral artery stenosis precluding insertion of the catheter\n* Untreated allergy to contrast media\n* Currently participating in the study of an investigational drug or device\n* Moderate to severe renal insufficiency'}, 'identificationModule': {'nctId': 'NCT01789918', 'acronym': 'ACHIEVE', 'briefTitle': 'TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation (ACHIEVE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ReCor Medical, Inc.'}, 'officialTitle': 'TrAnsCatHeter Intravascular Ultrasound Energy deliVery for rEnal Denervation', 'orgStudyIdInfo': {'id': 'CLIN-0030-HT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Percutaneous renal denervation', 'description': 'PARADISE percutaneous renal denervation', 'interventionNames': ['Device: PARADISE percutaneous renal denervation']}], 'interventions': [{'name': 'PARADISE percutaneous renal denervation', 'type': 'DEVICE', 'otherNames': ['ReCor Medical PARADISE'], 'description': 'Intravascular ultrasound emission', 'armGroupLabels': ['Percutaneous renal denervation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79189', 'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Universitäts-Herzzentrum Freiburg • Bad Krozingen', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60389', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'CardioVasculäres Centrum', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinik St. Georg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '66424', 'city': 'Homburg/Saar', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes'}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitätsklinikum Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '3015', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC - Thoraxcenter', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '413 45', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska Universitetssjukhuset', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Thomas Zeller, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitäts-Herzzentrum Freiburg • Bad Krozingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ReCor Medical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}