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Interest of Direct Aspiration First Pass Technique (ADAPT) for Thrombectomy Revascularisation of Large Vessel Occlusion in Acute Ischaemic Stroke (ASTER)

Primary Purpose

Ischemic Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
direct aspiration procedure
stent retriever procedure
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Cerebrovascular Accident

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Pellegrin
  • Hospices Civils de Lyon
  • CHU Dupuytren
  • CHU Hôpital Gui de Chaulac
  • Hôpital Neurologique
  • Hôpital Guillaume et René LAENNEC
  • Fondation Ophtalmologique Adolphe de Rothschild
  • Hôpital Foch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ADAPT

Stent Retriever

Arm Description

Outcomes

Primary Outcome Measures

Complete recanalization percentage
Proportion of patients in which complete recanalization is achieved as defined by a TICI score equal to 2b or 3

Secondary Outcome Measures

Full Information

First Posted
August 12, 2015
Last Updated
February 7, 2018
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT02523261
Brief Title
Interest of Direct Aspiration First Pass Technique (ADAPT) for Thrombectomy Revascularisation of Large Vessel Occlusion in Acute Ischaemic Stroke
Acronym
ASTER
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 10, 2015 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Cerebrovascular Accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
381 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADAPT
Arm Type
Experimental
Arm Title
Stent Retriever
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
direct aspiration procedure
Intervention Description
Revascularization by endovascular thrombectomy using the distal aspiration first pass technique
Intervention Type
Procedure
Intervention Name(s)
stent retriever procedure
Intervention Description
Revascularization by endovascular thrombectomy using a mechanical thrombectomy device
Primary Outcome Measure Information:
Title
Complete recanalization percentage
Description
Proportion of patients in which complete recanalization is achieved as defined by a TICI score equal to 2b or 3
Time Frame
Immediately after the revascularization procedure is completed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel PIOTIN
Organizational Affiliation
Fondation ophtalmologique de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Pellegrin
City
Bordeaux
Country
France
Facility Name
Hospices Civils de Lyon
City
Bron
Country
France
Facility Name
CHU Dupuytren
City
Limoges
Country
France
Facility Name
CHU Hôpital Gui de Chaulac
City
Montpellier
Country
France
Facility Name
Hôpital Neurologique
City
Nancy
Country
France
Facility Name
Hôpital Guillaume et René LAENNEC
City
Nantes
Country
France
Facility Name
Fondation Ophtalmologique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Hôpital Foch
City
Suresnes
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34134507
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. Erratum In: Stroke. 2021 Aug;52(9):e572.
Results Reference
derived
PubMed Identifier
33184069
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.
Results Reference
derived
PubMed Identifier
31471527
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.
Results Reference
derived
PubMed Identifier
30425161
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.
Results Reference
derived
PubMed Identifier
30414302
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.
Results Reference
derived
PubMed Identifier
29760012
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.
Results Reference
derived
PubMed Identifier
28763550
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.
Results Reference
derived
PubMed Identifier
28428348
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. Erratum In: Stroke. 2017 Jun;48(6):e152.
Results Reference
derived

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Interest of Direct Aspiration First Pass Technique (ADAPT) for Thrombectomy Revascularisation of Large Vessel Occlusion in Acute Ischaemic Stroke

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