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

NCT02523261 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2026-01-22

No results posted yet for this study

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 Unpublished data, Oral presentation at the European Stroke Organization, April 2015).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

Conditions

  • Ischemic Cerebrovascular Accident

Interventions

PROCEDURE

stent retriever procedure

Revascularization by endovascular thrombectomy using a mechanical thrombectomy device

PROCEDURE

direct aspiration procedure

Revascularization by endovascular thrombectomy using the distal aspiration first pass technique

Sponsors & Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Principal Investigators

  • Michel PIOTIN · Fondation ophtalmologique de Rothschild

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-10
Primary Completion
2016-10-31
Completion
2017-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02523261 on ClinicalTrials.gov