Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT03885635
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2019-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemiarch vs Extended Arch in Type 1 Aortic Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000784', 'term': 'Aortic Dissection'}], 'ancestors': [{'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Hemiarch vs. extended arch repair in the setting of acute DeBakey type 1 aortic dissections'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2019-03-16', 'studyFirstSubmitQcDate': '2019-03-19', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients experiencing a composite end-point of mortality or re-intervention', 'timeFrame': '3 years', 'description': 'Compare the proportion of patients between the two groups who over a 3 year follow up period attain a composite clinical end-point of 1) mortality, 2) late aortic re-intervention, either surgical or endovascular (\\> 30 days from index procedure) or 3) early (\\< 30 days from index procedure) re-intervention for branch malperfusion'}], 'secondaryOutcomes': [{'measure': 'Number of patients achieving complete false lumen thrombosis on CT imaging', 'timeFrame': '3 years', 'description': 'Compare the proportions of patients achieving complete false lumen (FL) thrombosis in the proximal, mid and distal descending thoracic aorta at 3 years after intervention between the two groups'}, {'measure': 'Delta change in the ratio of true lumen to total aortic area (TL: Ao)', 'timeFrame': '1 month', 'description': 'Compare delta change in the ratio of true lumen to total aortic area (TL:Ao) in the descending thoracic and abdominal aorta from pre-operative to first post-operative CT scans, between the two groups.'}, {'measure': 'Delta change in maximum cross-sectional descending thoracic aortic dimension', 'timeFrame': '3 years', 'description': 'Compare delta change in the maximum cross-sectional descending thoracic dimension between the two groups over 3 years'}, {'measure': 'Number of patients experiencing the listed peri-operative complications', 'timeFrame': '1 month', 'description': 'To compare the proportion of patients experiencing the following peri-operative complications between the two groups: mortality, stroke, paraplegia/paraparesis, vascular injury, renal ischemia, bowel ischemia warranting operative intervention, peripheral limb ischemic changes and re-operation for bleeding.'}, {'measure': 'Number of patients requiring open surgical or endovascular re-intervention', 'timeFrame': '3 years', 'description': 'Compare the proportion of patients requiring open surgical and endovascular re-intervention over 3 years in both groups'}, {'measure': 'Preoperative malperfusion and perioperative mortality/early re-intervention', 'timeFrame': '1 month', 'description': 'Correlate pre-operative CT signs of malperfusion with peri-operative mortality and early post-operative re-intervention in both groups'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Dissection']}, 'referencesModule': {'references': [{'pmid': '37084820', 'type': 'DERIVED', 'citation': 'Elbatarny M, Stevens LM, Dagenais F, Peterson MD, Vervoort D, El-Hamamsy I, Moon M, Al-Atassi T, Chung J, Boodhwani M, Chu MWA, Ouzounian M; Canadian Thoracic Aortic Collaborative Investigators. Hemiarch versus extended arch repair for acute type A dissection: Results from a multicenter national registry. J Thorac Cardiovasc Surg. 2024 Mar;167(3):935-943.e5. doi: 10.1016/j.jtcvs.2023.04.012. Epub 2023 Apr 20.'}]}, 'descriptionModule': {'briefSummary': 'HEADSTART is a prospective, open-label, non-blinded, multicenter, randomized controlled trial that compares a composite of mortality and re-intervention in patients undergoing hemiarch and extended arch repair for acute DeBakey type 1 aortic dissection. Eligible patients will be randomized to one or the other surgical strategy and clinical and imaging outcome data will be collected over a 3 year follow up period.', 'detailedDescription': "DeBakey Type 1 aortic dissections continue to have high operative mortality and morbidity and there is equipoise in available literature with regards to the best operative strategy and patient selection criteria. Hemiarch repair is current standard of care in most centers but extended arch repair is gaining popularity aiming to address early post-operative malperfusion and improve long term aortic remodeling.\n\nHEADSTART is a randomized controlled prospective trial of patients presenting to participating institutes with acute DeBakey 1 aortic dissection. Patients will be enrolled and randomized into one of two groups - 'hemiarch repair' and 'extended arch repair'. Pre-operative, early post-operative and long term follow clinical and CT imaging data will be collated on a centralized database and at a core lab respectively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Emergent surgical repair of Acute DeBakey Type 1 aortic dissection\n2. Age \\>18 years and \\<70 years\n3. Operating surgeon believes that both surgeries could be safe and effective\n\nExclusion Criteria\n\n1. Hemodynamic instability/shock defined as systolic BP \\< 90 mm Hg\n2. Previous cardiac surgery with sternotomy or thoracic endograft placement\n3. Aortic arch diameter \\> 6cm in which a concomitant arch replacement is judged necessary\n4. Procedures deemed to be "salvage operations" where the patient is unlikely to survive hospital discharge.\n5. GCS \\< 8 for more than 6 hours\n6. History of cirrhosis.\n7. History of chronic renal failure (baseline eGFR \\< 50)\n8. Metastatic malignancy\n9. Pregnancy'}, 'identificationModule': {'nctId': 'NCT03885635', 'acronym': 'HEADSTART', 'briefTitle': 'Hemiarch vs Extended Arch in Type 1 Aortic Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Heart Institute Research Corporation'}, 'officialTitle': 'Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)', 'orgStudyIdInfo': {'id': 'HEADSTART'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hemiarch repair', 'description': 'Standard hemiarch repair with open distal anastomosis in the proximal arch without replacement of the head vessels.', 'interventionNames': ['Procedure: Hemiarch repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Extended arch repair', 'description': 'Ascending aortic and arch replacement with or without head vessel re-implantation and single TEVAR device placement within 1 week.', 'interventionNames': ['Procedure: Extended arch repair']}], 'interventions': [{'name': 'Hemiarch repair', 'type': 'PROCEDURE', 'description': "Current standard of surgical repair consisting of ascending aortic replacement with open distal anastomosis at level of proximal arch under a period of hypothermic circulatory arrest . No surgical or endovascular intervention is carried out in the mid arch or descending aorta. Intra-operative management, including cannulation, cardioplegia, cerebral perfusion technique, and neurologic monitoring will be done according to each institution's current standard of practice.", 'armGroupLabels': ['Hemiarch repair']}, {'name': 'Extended arch repair', 'type': 'PROCEDURE', 'description': "Surgical replacement of the ascending aorta along with intervention on the arch and descending aorta. Techniques for distal aspect of extended arch technique include but are not limited to total arch replacement along with TEVAR, Frozen Elephant Trunk procedure or surgical proximal arch replacement with bare metal stents in arch and descending aorta. Intra-operative management, including cannulation, cardioplegia, cerebral perfusion technique, and neurologic monitoring will be done according to each institution's current standard of practice.", 'armGroupLabels': ['Extended arch repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A5A5', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Stephen Mardell', 'role': 'CONTACT', 'email': 'Stephen.Mardell@lhsc.on.ca', 'phone': '5196858500', 'phoneExt': '34070'}, {'name': 'Michael Chu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Waleed Alnimr', 'role': 'CONTACT', 'email': 'Waleed.AlNimr@uhn.ca', 'phone': '416 340 4800'}, {'name': 'Maral Ouzounian, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jennifer Chung, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Asma Hamlili', 'role': 'CONTACT', 'email': 'asma.hamlili@icm-mhi.org', 'phone': '514-376-3330', 'phoneExt': '3725'}, {'name': 'Alexandre Bergeron', 'role': 'CONTACT', 'email': 'alexandre.bergeron.icm@icm-mhi.org', 'phone': '514-376-3330', 'phoneExt': '3725'}, {'name': 'Philippe Demers, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marina Ibrahim, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Raymond Cartier, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Annie Bergeron', 'role': 'CONTACT', 'email': 'annie.bergeron@criucpq.ulaval.ca', 'phone': '418-656-8711', 'phoneExt': '2768'}, {'name': 'François Dagenais, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eric Dumont, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Charles Laurin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jean Porterie, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institut Universitaire De Cardiologie Et De Pneumologie de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Khatira Mehdiyeva', 'role': 'CONTACT', 'email': 'kmehdiyeva@ottawaheart.ca', 'phone': '613-696-7000', 'phoneExt': '18328'}, {'name': 'Alice Black', 'role': 'CONTACT', 'email': 'AlBlack@ottawaheart.ca', 'phone': '403-389-8958', 'phoneExt': '613-696-7230'}], 'overallOfficials': [{'name': 'Munir Boodhwani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ottawa Heart Institute Research Corporation'}, {'name': 'Jehangir Appoo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Heart Institute Research Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}