Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:30 AM
Study NCT ID:
NCT07475260
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SVF-Treo Study: Influence of Cardiac and Respiratory Pulsatility Deformation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D004562', 'term': 'Electrocardiography'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who experience treatment success.', 'timeFrame': 'One year post procedure.', 'description': 'Treatment success is defined as freedom from the following: Type I and III endoleak; stent graft migration; AAA enlargement; AAA rupture; conversion to open surgery; significant twists, kinks or obstruction; aneurysm-related patient death.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Abdominal Aortic Aneurysm', 'Endovascular Aneurysm Repair', 'FEVAR', 'Computed Tomography Imaging', 'CT', 'ECGgated'], 'conditions': ['Abdominal Aortic Aneurysm', 'Endovascular Abdominal Aortic Aneurysm Repair', 'Fenestrated Endovascular Aortic Repair']}, 'descriptionModule': {'briefSummary': 'This is a national multicenter study with 25 patients with a complex AAA undergoing endovascular repair with the Fenestrated TREO™ stent graft. ECG and respiratory-gated CT scans will be performed pre-operatively, at discharge, after 6 months, and after 12 months follow up. If stent movement is still present in after 12 months, then another scan will be taken at 24 months. To include respiratory gated with the ECG-gated, patients will undergo ECG-gated CT scan during an inspiration breath-hold as well as an expiration breath-hold. This double gated CT scans will allow us to analyse the movement of the stent graft caused by the cardiac cycle and respiratory cycle.\n\nThe duration of this study is 2.5 years.', 'detailedDescription': "Fenestrated endovascular aortic repair (F-EVAR) uses stent grafts with customized fenestrations to treat complex aortic aneurysms in patients at risk of aneurysm rupture. The long-term durability of these stent grafts is hindered by complications requiring reintervention. Especially the perirenal fixation and sealing area is of vital importance. The customized fenestrations in the stent graft are cannulated with stents into the renal and/or mesenteric arteries, challenging the perirenal fixation. Once implanted, the aorta dynamics and the device affect each other in ways that are currently not understood. Pre and post- operative imaging of aortic aneurysm is routinely performed using computerized tomographic angiography (CTA). However, these static techniques do not consider the aorta dynamics. Consequently, our understanding of the dynamic behavior of the stent graft and stented target vessels is limited. ECG-gated CTA is a technique that takes the patient's heart cycle into account and taking the ECG-gated CTA during inspiration and during expiration takes the patients respiratory motion into account, creating a double gated CT scan. This double gated CTA enables studying the motion of aorta and implanted devices."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of 25 patients with an abdominal aortic aneurysms to be treated with F-EVAR, aged \\>65. The study population are patients from either Medisch Spectrum Twente (MST), Rijnstate Ziekenhuis, Jeroen Bosch Ziekenhuis, Amsterdam UMC, UMC Utrecht and Zuyderland Medisch Centrum.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asymptomatic AAA,\n* Age \\> 65\n* Indication for AAA treatment according to standard practice\n* Anatomic suitability for the fenestrated Treo stent graft\n* At least one stentable main renal artery and one other stentable renal or mesenteric artery\n* Being able to hold their breath for 10 seconds.\n\nExclusion Criteria:\n\n* No informed consent obtained\n* eGFR \\< 30 ml/min\n* Allergy for intra venous contrast fluid.'}, 'identificationModule': {'nctId': 'NCT07475260', 'acronym': 'SVF-Treo', 'briefTitle': 'SVF-Treo Study: Influence of Cardiac and Respiratory Pulsatility Deformation', 'organization': {'class': 'OTHER', 'fullName': 'University of Twente'}, 'officialTitle': 'Investigating the Influence of Cardiac and Respiratory Pulsatility Deformation on the Abdominal Aorta Before and After the Implantation of the Fenestrated TREO.', 'orgStudyIdInfo': {'id': 'SVF-Treo'}, 'secondaryIdInfos': [{'id': 'NL-009578 R027471', 'type': 'OTHER', 'domain': 'Centrale Commissie Mensgebonden Onderzoek (CCMO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Complex AAA Patients', 'description': 'The entire cohort consists of patients with an abdominal aortic aneurysm eligible for fenestrated endovascular aortic repair using a fenestrated Treo device.', 'interventionNames': ['Diagnostic Test: CT scan']}], 'interventions': [{'name': 'CT scan', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['ECG and respiratory -gated CT scan', 'Double gated CT scan'], 'description': 'ECG-gated CT is a technique in which the ECG of the patient is measured during scanning. This can be used during scanning for instance to apply the most dose in the diastolic phase of the cardiac cycle (where motion is lowest), a technique known as prospective gating. In retrospective gating, the ECG is used to split the data in bins corresponding to a specific phase of the cardiac cycle, and creating one volumetric image per bin. To incorporate the respiratory cycle with the ECG-gated CT scan, an ECG-gated CT scan will be taken during inspirational breath-hold and during expiration breath-hold. Creating one CT scan with two phases, inspiration ECG-gated and an expiration ECG-gated scan.\n\nThis is the technique that we will be using in this study; it allows us to study the temporal aspects of the data.', 'armGroupLabels': ['Complex AAA Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6815AD', 'city': 'Arnhem', 'state': 'Gelderland', 'country': 'Netherlands', 'contacts': [{'name': 'Michel M.P.J. Reijnen', 'role': 'CONTACT'}, {'name': 'Michel M.P.J. Reijnen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rijnstate Ziekenhuis', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'zip': '5223 GZ', 'city': "'s-Hertogenbosch", 'state': 'North Brabant', 'country': 'Netherlands', 'contacts': [{'name': 'Jan Willem Hinnen', 'role': 'CONTACT', 'email': 'j.hinnen@jbz.nl'}, {'name': 'Jan Willem Hinnen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jeroen Bosch Ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'contacts': [{'name': 'Kak Khee Yeung', 'role': 'CONTACT', 'email': 'k.yeung@amsterdamumc.nl'}, {'name': 'Kak Khee Yeung', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '7512KZ', 'city': 'Enschede', 'state': 'Overijssel', 'country': 'Netherlands', 'contacts': [{'name': 'Robert H Geelkerken', 'role': 'CONTACT', 'email': 'r.geelkerken@mst.nl'}, {'name': 'Anja Stam', 'role': 'CONTACT', 'email': 'researchbureau.heelkunde@mst.nl'}, {'name': 'Robert H Geelkerken', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '3584 CX', 'city': 'Utrecht', 'state': 'Utrecht', 'country': 'Netherlands', 'contacts': [{'name': 'Joost A van Herwaarden', 'role': 'CONTACT', 'email': 'j.a.vanherwaarden@umcu.nl'}, {'name': 'Joost A vvan Herwaarden', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '6419PC', 'city': 'Heerlen', 'country': 'Netherlands', 'contacts': [{'name': 'Lee Bouwman', 'role': 'CONTACT', 'email': 'l.bouwman@zuyderland.nl'}, {'name': 'Lee Bouwman', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zuyderland Medisch Centrum', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}], 'centralContacts': [{'name': 'Elke Hestermann', 'role': 'CONTACT', 'email': 'e.hestermann@utwente.nl', 'phone': '+31 (0)53 489 4537'}, {'name': 'Robert H Geelkerken', 'role': 'CONTACT', 'email': 'r.h.geelkerken@utwente.nl'}], 'overallOfficials': [{'name': 'Robert H Geelkerken', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Twente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Twente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinating Investigator', 'investigatorFullName': 'Elke Hestermann', 'investigatorAffiliation': 'University of Twente'}}}}