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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
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Tracking Information
First Submitted Date  ICMJE August 12, 2015
First Posted Date  ICMJE August 14, 2015
Last Update Posted Date February 8, 2018
Actual Study Start Date  ICMJE October 10, 2015
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interest of Direct Aspiration First Pass Technique (ADAPT) for Thrombectomy Revascularisation of Large Vessel Occlusion in Acute Ischaemic Stroke
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Cerebrovascular Accident
Intervention  ICMJE
  • Procedure: direct aspiration procedure
    Revascularization by endovascular thrombectomy using the distal aspiration first pass technique
  • Procedure: stent retriever procedure
    Revascularization by endovascular thrombectomy using a mechanical thrombectomy device
Study Arms  ICMJE
  • Experimental: ADAPT
    Intervention: Procedure: direct aspiration procedure
  • Active Comparator: Stent Retriever
    Intervention: Procedure: stent retriever procedure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2017)
381
Original Estimated Enrollment  ICMJE
 (submitted: August 12, 2015)
322
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02523261
Other Study ID Numbers  ICMJE MPN_2015_22
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor  ICMJE Fondation Ophtalmologique Adolphe de Rothschild
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michel PIOTIN Fondation ophtalmologique de Rothschild
PRS Account Fondation Ophtalmologique Adolphe de Rothschild
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP