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

January 21, 2026 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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 Unpublished data, Oral presentation at the European Stroke Organization, April 2015).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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

381

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • CHU Pellegrin
      • Bron, France
        • Hospices Civils de Lyon
      • Limoges, France
        • Chu Dupuytren
      • Montpellier, France
        • CHU Hôpital Gui de Chaulac
      • Nancy, France
        • Hôpital neurologique
      • Nantes, France
        • Hôpital Guillaume et René Laënnec
      • Paris, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild
      • Suresnes, France
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately after the revascularization procedure is completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Michel PIOTIN, Fondation ophtalmologique de Rothschild

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

August 12, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (Estimated)

August 14, 2015

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPN_2015_22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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