Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-27 @ 9:22 PM
Study NCT ID:
NCT02523261
Status:
COMPLETED
Last Update Posted:
2018-02-08
First Post:
2015-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Direct Aspiration First Pass Technique (ADAPT) for Thrombectomy Revascularisation of Large Vessel Occlusion in Acute Ischaemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 381}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-07', 'studyFirstSubmitDate': '2015-08-12', 'studyFirstSubmitQcDate': '2015-08-12', 'lastUpdatePostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete recanalization percentage', 'timeFrame': 'Immediately after the revascularization procedure is completed', 'description': 'Proportion of patients in which complete recanalization is achieved as defined by a TICI score equal to 2b or 3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ischemic Cerebrovascular Accident']}, 'referencesModule': {'references': [{'pmid': '34134507', 'type': 'DERIVED', 'citation': 'Maier B, Robichon E, Bourcier R, Dargazanli C, Labreuche J, Thion LA, Leguen M, Riem R, Desilles JP, Boulouis G, Delvoye F, Hebert S, Redjem H, Smajda S, Escalard S, Blanc R, Piotin M, Lapergue B, Mazighi M; ASTER Trialdagger. Association of Hypotension During Thrombectomy and Outcomes Differs With the Posterior Communicating Artery Patency. Stroke. 2021 Aug;52(9):2964-2967. doi: 10.1161/STROKEAHA.121.034542. Epub 2021 Jun 17.'}, {'pmid': '33184069', 'type': 'DERIVED', 'citation': 'Derraz I, Pou M, Labreuche J, Legrand L, Soize S, Tisserand M, Rosso C, Piotin M, Boulouis G, Oppenheim C, Naggara O, Bracard S, Clarencon F, Lapergue B, Bourcier R; ASTER and the THRACE Trials Investigators. Clot Burden Score and Collateral Status and Their Impact on Functional Outcome in Acute Ischemic Stroke. AJNR Am J Neuroradiol. 2021 Jan;42(1):42-48. doi: 10.3174/ajnr.A6865. Epub 2020 Nov 12.'}, {'pmid': '31471527', 'type': 'DERIVED', 'citation': 'Ducroux C, Piotin M, Gory B, Labreuche J, Blanc R, Ben Maacha M, Lapergue B, Fahed R; ASTER Trial investigators. First pass effect with contact aspiration and stent retrievers in the Aspiration versus Stent Retriever (ASTER) trial. J Neurointerv Surg. 2020 Apr;12(4):386-391. doi: 10.1136/neurintsurg-2019-015215. Epub 2019 Aug 30.'}, {'pmid': '30425161', 'type': 'DERIVED', 'citation': 'Rosso C, Blanc R, Ly J, Samson Y, Lehericy S, Gory B, Marnat G, Mazighi M, Consoli A, Labreuche J, Saleme S, Costalat V, Bracard S, Desal H, Piotin M, Lapergue B; ASTER Trial and Pitie-Salpetriere Investigators. Impact of infarct location on functional outcome following endovascular therapy for stroke. J Neurol Neurosurg Psychiatry. 2019 Mar;90(3):313-319. doi: 10.1136/jnnp-2018-318869. Epub 2018 Nov 13.'}, {'pmid': '30414302', 'type': 'DERIVED', 'citation': 'Guenego A, Lecler A, Raymond J, Sabben C, Khoury N, Premat K, Botta D, Boisseau W, Maier B, Ciccio G, Redjem H, Smajda S, Ducroux C, Di Meglio L, Davy V, Olivot JM, Wang A, Duplantier J, Roques M, Krystal S, Koskas P, Collin A, Ben Maacha M, Hamdani M, Zuber K, Blanc R, Piotin M, Fahed R; Aspiration versus STEnt-Retriever (ASTER) trial investigators. Hemorrhagic transformation after stroke: inter- and intrarater agreement. Eur J Neurol. 2019 Mar;26(3):476-482. doi: 10.1111/ene.13859. Epub 2018 Dec 7.'}, {'pmid': '29760012', 'type': 'DERIVED', 'citation': 'Fahed R, Ben Maacha M, Ducroux C, Khoury N, Blanc R, Piotin M, Lapergue B; ASTER Trial Investigators. Agreement between core laboratory and study investigators for imaging scores in a thrombectomy trial. J Neurointerv Surg. 2018 Dec;10(12):e30. doi: 10.1136/neurintsurg-2018-013867. Epub 2018 May 14.'}, {'pmid': '28763550', 'type': 'DERIVED', 'citation': 'Lapergue B, Blanc R, Gory B, Labreuche J, Duhamel A, Marnat G, Saleme S, Costalat V, Bracard S, Desal H, Mazighi M, Consoli A, Piotin M; ASTER Trial Investigators. Effect of Endovascular Contact Aspiration vs Stent Retriever on Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion: The ASTER Randomized Clinical Trial. JAMA. 2017 Aug 1;318(5):443-452. doi: 10.1001/jama.2017.9644.'}, {'pmid': '28428348', 'type': 'DERIVED', 'citation': 'Blanc R, Redjem H, Ciccio G, Smajda S, Desilles JP, Orng E, Taylor G, Drumez E, Fahed R, Labreuche J, Mazighi M, Lapergue B, Piotin M. Predictors of the Aspiration Component Success of a Direct Aspiration First Pass Technique (ADAPT) for the Endovascular Treatment of Stroke Reperfusion Strategy in Anterior Circulation Acute Stroke. Stroke. 2017 Jun;48(6):1588-1593. doi: 10.1161/STROKEAHA.116.016149. Epub 2017 Apr 20.'}]}, 'descriptionModule': {'briefSummary': 'Mechanical thrombectomy (TM) is now validated through 4 randomized controlled trials of high scientific level as the reference treatment of cerebral infarction associated with proximal cerebral occlusion (MR CLEAN, ESCAPE 2014, 2015). These studies have shown for the first time a major decrease (-35%) of disability related to severe cerebral infarction and reduction in mortality. These studies only used thrombectomy devices called stent retriever for obtaining recanalization rates ranging from 58-72% for the 2 largest studies (MR CLEAN, ESCAPE 2014, 2015). This criterion "recanalization" is important because it largely determines the functional prognosis of patients with severe cerebral infarction (Khatri, 2014).\n\nThese results are exciting but we can do even better. Indeed, already new thrombectomy devices are available with a special interest for ADAPT (A Direct Aspiration First Pass Technic). This distal suction system, with a high level of endovascular navigability, provides high recanalization rates (\\> 90%), low morbidity, with a synergistic effect with stent retriever (Turk A, Kowoll 2014 and 2015). To date, these technic (ADAPT) has never been assessed in a randomized controlled trial.\n\nWe have previously conducted a comparative observational study between two recanalization strategies by thrombectomy using first-line ADAPT or the most widely used stent retriever. The interventional neuroradiologist could, in case of recanalization failure with the Solitaire system, used another thrombectomy material left to the operator\'s choice. 244 consecutive patients on two centers (Rothschild Foundation, and Foch Hospital, France) admitted for a cerebral infarction associated with proximal occlusion were included. This is so far the largest series of patients with ADAPT system. The complete recanalization rate was 84% with ADAPT versus 68% with stent retriever (P = 0.006). Unpublished data, Oral presentation at the European Stroke Organization, April 2015). Our research aims to show that a first line strategy of recanalization by thrombectomy using a distal suction system (ADAPT) is superior that the use of a stent retriever.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years with no upper age limit.\n* Cerebral infarction in the anterior circulation\n* Occlusion of the anterior circulation proven by CT angiography or MR angiography\n* With or without previous Intravenous thrombolysis\n* Start of thrombectomy procedure within 6 hours of symptoms onset.\n* Patient expresses verbally his non-opposition to be enrolled in the study ; in case patient cannot communicate, verbal non-opposition is obtained from his close / trusted person\n\nExclusion Criteria:\n\n* Absence of indication for thrombectomy\n* Cons-indication for thrombectomy\n* Presence of cerebral infarction of the posterior circulation\n* Occlusion of the cervical carotid artery\n* Allergy to x-ray contrast products\n* Patient was bedridden or using a wheelchair most of the day (pre-event modified Rankin Scale score \\> 3) prior to stroke\n* Pregnancy or breastfeeding\n* Patient under legal protection\n* No affiliation to health insurance\n\nSecondary exclusion criteria\n\n\\- Lack of access route for catheterization'}, 'identificationModule': {'nctId': 'NCT02523261', 'acronym': 'ASTER', 'briefTitle': 'Interest of Direct Aspiration First Pass Technique (ADAPT) for Thrombectomy Revascularisation of Large Vessel Occlusion in Acute Ischaemic Stroke', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'orgStudyIdInfo': {'id': 'MPN_2015_22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADAPT', 'interventionNames': ['Procedure: direct aspiration procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stent Retriever', 'interventionNames': ['Procedure: stent retriever procedure']}], 'interventions': [{'name': 'direct aspiration procedure', 'type': 'PROCEDURE', 'description': 'Revascularization by endovascular thrombectomy using the distal aspiration first pass technique', 'armGroupLabels': ['ADAPT']}, {'name': 'stent retriever procedure', 'type': 'PROCEDURE', 'description': 'Revascularization by endovascular thrombectomy using a mechanical thrombectomy device', 'armGroupLabels': ['Stent Retriever']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Bron', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'city': 'Limoges', 'country': 'France', 'facility': 'CHU Dupuytren', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Hôpital Gui de Chaulac', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nancy', 'country': 'France', 'facility': 'Hôpital Neurologique', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Hôpital Guillaume et René LAENNEC', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Fondation Ophtalmologique Adolphe de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Suresnes', 'country': 'France', 'facility': 'Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Michel PIOTIN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation ophtalmologique de Rothschild'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}