Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT02493634
Status:
COMPLETED
Last Update Posted:
2018-03-30
First Post:
2015-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-28', 'studyFirstSubmitDate': '2015-06-22', 'studyFirstSubmitQcDate': '2015-07-08', 'lastUpdatePostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural success', 'timeFrame': 'Up to 30 days after procedure', 'description': 'procedural success means that insertion, steerability and visibility of the guide wire in the MR guided intervention was successfully reached, in the absence of adverse events up to 30 days after procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Magnetic Resonance spectroscopy', 'Aortic Arch'], 'conditions': ['Congenital Heart Defect']}, 'referencesModule': {'references': [{'pmid': '19115070', 'type': 'BACKGROUND', 'citation': 'Kos S, Huegli R, Hofmann E, Quick HH, Kuehl H, Aker S, Kaiser GM, Borm PJ, Jacob AL, Bilecen D. First magnetic resonance imaging-guided aortic stenting and cava filter placement using a polyetheretherketone-based magnetic resonance imaging-compatible guidewire in swine: proof of concept. Cardiovasc Intervent Radiol. 2009 May;32(3):514-21. doi: 10.1007/s00270-008-9483-5. Epub 2008 Dec 30.'}, {'pmid': '19431070', 'type': 'BACKGROUND', 'citation': 'Kos S, Huegli R, Hofmann E, Quick HH, Kuehl H, Aker S, Kaiser GM, Borm PJ, Jacob AL, Bilecen D. MR-compatible polyetheretherketone-based guide wire assisting MR-guided stenting of iliac and supraaortic arteries in swine: feasibility study. Minim Invasive Ther Allied Technol. 2009;18(3):181-8. doi: 10.1080/13645700902921971.'}, {'pmid': '19252440', 'type': 'BACKGROUND', 'citation': 'Kos S, Huegli R, Hofmann E, Quick HH, Kuehl H, Aker S, Kaiser GM, Borm PJ, Jacob AL, Bilecen D. Feasibility of real-time magnetic resonance-guided angioplasty and stenting of renal arteries in vitro and in Swine, using a new polyetheretherketone-based magnetic resonance-compatible guidewire. Invest Radiol. 2009 Apr;44(4):234-41. doi: 10.1097/RLI.0b013e31819b00f1.'}]}, 'descriptionModule': {'briefSummary': 'This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety and performance of magnetic resonance imaging conditional guide wire and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.', 'detailedDescription': 'This is post-market clinical follow-up study on 25 consecutive patients in two centers to evaluate the safety of a guide wire conditional for use in magnetic resonance imaging and the acceptability of identified risks in the clinical evaluation and to detect emerging risks on the basis of factorial evidence.\n\nThe guidewire is used to access the patients central circulatory system and in particular for the introduction and exact placement of a pressure catheter to measure the pressure gradient over the aortic arch. The procedure will be done in patients with a clinical indication for cardiac magnetic resonance and conventional catheterisation.Patients need to have a body weight over 40 kg and the introduction of a 5 French catheter should be possible. The primary endpoint is the measurement of procedural success, defined as successful insertion, steerability and visibility in MRI, in the absence of device related adverse events such as damage to vessel wall. In addition structural integrity of the instruments is to be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with clinical indication for cardiac magnetic resonance and conventional diagnostic catheterisation\n* patients with body weight of \\> 40 kg in which the introduction of an introducer of \\> 5 French is possible.\n* subject provided written informed consent using the approved consent form or in case of a minor the subject provided written assent and its legal guardian provided written informed consent.\n\nExclusion Criteria:\n\n* major surgery in the last 42 days\n* history of irreversible bleeding disorder\n* contraindication to cardiac magnetic resonance\n* Contraindications to guidewire procedures, such as evidence of active infection\n* women of child-bearing potential who cannot provide a negative pregnancy test\n* chronic total occlusion.'}, 'identificationModule': {'nctId': 'NCT02493634', 'acronym': 'MRWIREPMCF', 'briefTitle': 'Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nano4Imaging GmbH'}, 'officialTitle': 'Post-market Clinical Follow-up Study With Magnetic Resonance Imaging Conditional Guide Wire', 'orgStudyIdInfo': {'id': 'N4IPMCF2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'pressure gradient measurement', 'description': 'Diagnostic procedure to measure pressure gradient in series of patients. Focus is on safety and absence of adverse events', 'interventionNames': ['Procedure: pressure gradient measurement', 'Device: MRWire']}], 'interventions': [{'name': 'pressure gradient measurement', 'type': 'PROCEDURE', 'otherNames': ['MRWire'], 'description': 'A guidewire is used to introduce and position a pressure catheter under magnetic resonance guidance to conduct flow and pressure measurement in the aortic arch to evaluate vascular resistance.', 'armGroupLabels': ['pressure gradient measurement']}, {'name': 'MRWire', 'type': 'DEVICE', 'armGroupLabels': ['pressure gradient measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80636', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum Munchen', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': 'WC1N 1EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital- Great Ormond Street Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Peter Ewert, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'German Heart Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nano4Imaging GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CERES GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}