Interest of Direct Aspiration First Pass Technique (ADAPT) for Thrombectomy Revascularisation of Large Vessel Occlusion in Acute Ischaemic Stroke (ASTER)
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|ClinicalTrials.gov Identifier: NCT02523261|
Recruitment Status : Completed
First Posted : August 14, 2015
Last Update Posted : February 8, 2018
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).
These 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.
We 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 Unpublished data, Oral presentation at the European Stroke Organization, April 2015).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.
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Cerebrovascular Accident||Procedure: direct aspiration procedure Procedure: stent retriever procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||381 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||October 10, 2015|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||February 2017|
Procedure: direct aspiration procedure
Revascularization by endovascular thrombectomy using the distal aspiration first pass technique
|Active Comparator: Stent Retriever||
Procedure: stent retriever procedure
Revascularization by endovascular thrombectomy using a mechanical thrombectomy device
- Complete recanalization percentage [ Time Frame: Immediately after the revascularization procedure is completed ]Proportion of patients in which complete recanalization is achieved as defined by a TICI score equal to 2b or 3
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523261
|Hospices Civils de Lyon|
|CHU Hôpital Gui de Chaulac|
|Hôpital Guillaume et René LAENNEC|
|Fondation Ophtalmologique Adolphe de Rothschild|
|Paris, France, 75019|
|Principal Investigator:||Michel PIOTIN||Fondation ophtalmologique de Rothschild|