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Completed

NCT Number: NCT03290885

Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral Infarction

Mechanical thrombectomy (MT) with a stent retriever (SR) device is now the standard intervention in ischemic stroke with large vessel occlusion. Favorable outcome is strongly associated with the successful reperfusion status. New device of MT such as contact aspiration seems promising to increase reperfusion status and clinical outcome.

The main hypothesis is to show the superiority of combining the use of contact aspiration with a stent retriever compared to a stent retriever alone in treatment of acute stroke due to proximal arterial occlusion.

The primary endpoint is the rate of perfect reperfusion score at the end of the endovascular procedure.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 and older (i.e., candidates must have had their 18th birthday)
  • Groin puncture carried out within 8 hours of first symptoms
  • Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation, M1 or M2)
  • Consenting requirements met according to French laws.
  • With or without intravenous thrombolysis

Exclusion criteria

  • Absence of large vessel occlusion on non-invasive imaging
  • Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory
  • Suspected pregnancy; if, a woman is of childbearing potential, a urine or serum beta human chorionic gonadotropin (betaHCG) test is positive.
  • Severe contrast medium allergy or absolute contraindication to iodinated agents.
  • Patient has severe or fatal comorbidities that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
  • Acute ischemic stroke involving posterior circulation (vertebrobasilar occlusion)
  • Angiographic evidence of carotid dissection or tandem cervical occlusion or stenosis requiring treatment.
  • Patients benefiting from a legal protection
  • Non-membership of a national insurance scheme
  • Opposition of the patient or (in case of inclusion as a matter of urgency) of the trustworthy person

Treatment and study plan

Combined contact aspiration/Stent Retriever Technique

Combination Product

Combined contact aspiration/SR is performed using a balloon-guide catheter (BGC). A 0.021 to 0.027 inch inner lumen microcatheter with a 0.014 to 0.016 inch micro-wire inside is introduced into a large-bore aspiration catheter and this construct is introduced into BGC. The BGC is placed into the origin of the cervical internal carotid artery (ICA). The catheter is advanced past the thrombus over the micro-wire to allow the SR deployment. The SR is deployed across the occlusion. Then the large bore distal access catheter is advanced to contact the proximal edge of the SR. The aspiration pump is connected to the large bore distal access catheter. After at least 90 sec, the SR and the large bore distal access catheter are pulled out as an unit from the BGC and the patient. Manual aspiration is also be applied to the BGC during the pull-out manoeuver which is performed after the temporary inflation of the balloon at the tip of the BGC to ensure flow arrest into the carotid

Stent retriever technique

Device

The technique used should be in accordance with the device instruction for use. A large bore balloon guide catheter has to be placed into the cervical ICA.

A suitable delivery microcatheter is navigated over a micro-wire into the occluded major coronary artery MCA and across the occlusion. A control superselective angiogram may be used to document the extent of occlusion and thrombus. The stent retriever device is then deployed across the occlusion.

After at least 90 seconds, removal should occur with proximal occlusion by inflation of the balloon guide catheter.

Primary outcomes

  1. Perfect reperfusion rate

    Time frame: 24 hours

    Perfect reperfusion rate at the end of angiography defined as a Thrombolysis In Cerebral Infarction (TICI) 2c/3 score (TICI score = Thrombolysis In Cerebral Infarction)

Secondary outcomes

  1. Rate of successful reperfusion

    Time frame: 24 hours

    Rate of successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) at end of endovascular procedure

  2. Rate of perfect (mTICI 2c/3), successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) after the frontline strategy

    Time frame: 24 hours

  3. Time from groin puncture to achieve TICI 2c or better revascularization

    Time frame: 24 hours

    Time from groin puncture to achieve TICI 2c or better revascularization

  4. Time between groin puncture to clot contact and clot contact to maximum reperfusion

    Time frame: 24 hours

    Time between groin puncture to clot contact and clot contact to maximum reperfusion

  5. Modified Rankin scale (mRs)

    Time frame: 90 days

    Global disability assessed by overall distribution of mRs at 90-days

  6. Rate of favorable functional independence

    Time frame: 90 days

    Rate of favorable functional independence defined as a mRS 0-2 at 90 days

  7. Rate of excellent functional outcome

    Time frame: 90 days

    Rate of excellent functional outcome defined as a Modified Rankin scale (mRS) 0-1 at 90 days

  8. NIHSS score

    Time frame: 24 hours

    Change in NIHSS from baseline to 24 hours (delta NIHSS)

  9. Rate of symptomatic and asymptomatic intracerebral hemorrhage

    Time frame: 24 hours

    Rate of symptomatic and asymptomatic intracerebral hemorrhage at MRI 24h after thrombectomy (according the third European Cooperative Acute Stroke Study (ECASS3) classification) (independent core lab adjudication).

  10. Rate of parenchymal hematoma

    Time frame: 90 days

  11. Rate of all-cause mortality

    Time frame: 90 days

  12. Rate of periprocedural complications

    Time frame: 90 days

    • Rate of periprocedural complications: Occurrence of emboli to new territory (ENT), vasospasm, dissection, or perforation.

  13. Average cost per patient

    Time frame: 90 days

    Average cost per patient with complete recanalization

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral Infarction: the Randomized ASTER2 Study

Acronym: ASTER2

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2017
Registry last updated
May 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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