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 |
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Recruitment Status :
Completed
First Posted : August 14, 2015
Last Update Posted : February 8, 2018
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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 Unpublished data, Oral presentation at the European Stroke Organization, April 2015).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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Actual Study Start Date : | October 10, 2015 |
| Actual Primary Completion Date : | October 2016 |
| Actual Study Completion Date : | February 2017 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: ADAPT |
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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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 18 years with no upper age limit.
- Cerebral infarction in the anterior circulation
- Occlusion of the anterior circulation proven by CT angiography or MR angiography
- With or without previous Intravenous thrombolysis
- Start of thrombectomy procedure within 6 hours of symptoms onset.
- 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
Exclusion Criteria:
- Absence of indication for thrombectomy
- Cons-indication for thrombectomy
- Presence of cerebral infarction of the posterior circulation
- Occlusion of the cervical carotid artery
- Allergy to x-ray contrast products
- Patient was bedridden or using a wheelchair most of the day (pre-event modified Rankin Scale score > 3) prior to stroke
- Pregnancy or breastfeeding
- Patient under legal protection
- No affiliation to health insurance
Secondary exclusion criteria
- Lack of access route for catheterization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523261
| France | |
| CHU Pellegrin | |
| Bordeaux, France | |
| Hospices Civils de Lyon | |
| Bron, France | |
| CHU Dupuytren | |
| Limoges, France | |
| CHU Hôpital Gui de Chaulac | |
| Montpellier, France | |
| Hôpital Neurologique | |
| Nancy, France | |
| Hôpital Guillaume et René LAENNEC | |
| Nantes, France | |
| Fondation Ophtalmologique Adolphe de Rothschild | |
| Paris, France, 75019 | |
| Hôpital Foch | |
| Suresnes, France | |
| Principal Investigator: | Michel PIOTIN | Fondation ophtalmologique de Rothschild |
| Responsible Party: | Fondation Ophtalmologique Adolphe de Rothschild |
| ClinicalTrials.gov Identifier: | NCT02523261 |
| Other Study ID Numbers: |
MPN_2015_22 |
| First Posted: | August 14, 2015 Key Record Dates |
| Last Update Posted: | February 8, 2018 |
| Last Verified: | February 2018 |
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Stroke Ischemic Stroke Ischemia Pathologic Processes Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |