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

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Device: Stent retriever technique; Combination Product: Combined contact aspiration/Stent Retriever Technique

• Registration Number: NCT03290885
• Lead Sponsor: Hopital Foch

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-25
• Study Start: 2017-10-16
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-22
• Last Update Posted: 2020-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 408

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stent retriever mechanical thrombectomy alone	Stent retriever technique	Stent retriever mechanical thrombectomy alone for recanalisation
Combined use of contact aspiration and stent retriever	Combined contact aspiration/Stent Retriever Technique	Combined use of contact aspiration and stent retriever mechanical thrombectomy for recanalization

Primary Outcome Measures

Name	Time	Method
Perfect reperfusion rate	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 Outcome Measures

Name	Time	Method
Rate of periprocedural complications	90 days	- Rate of periprocedural complications: Occurrence of emboli to new territory (ENT), vasospasm, dissection, or perforation.
Average cost per patient	90 days	Average cost per patient with complete recanalization
Modified Rankin scale (mRs)	90 days	Global disability assessed by overall distribution of mRs at 90-days
Rate of symptomatic and asymptomatic intracerebral hemorrhage	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).
Rate of all-cause mortality	90 days
Rate of favorable functional independence	90 days	Rate of favorable functional independence defined as a mRS 0-2 at 90 days
Rate of excellent functional outcome	90 days	Rate of excellent functional outcome defined as a Modified Rankin scale (mRS) 0-1 at 90 days
NIHSS score	24 hours	Change in NIHSS from baseline to 24 hours (delta NIHSS)
Rate of successful reperfusion	24 hours	Rate of successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) at end of endovascular procedure
Rate of perfect (mTICI 2c/3), successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) after the frontline strategy	24 hours
Rate of parenchymal hematoma	90 days
Time from groin puncture to achieve TICI 2c or better revascularization	24 hours	Time from groin puncture to achieve TICI 2c or better revascularization
Time between groin puncture to clot contact and clot contact to maximum reperfusion	24 hours	Time between groin puncture to clot contact and clot contact to maximum reperfusion

Trial Locations

Locations (11)

Kremlin-Bicêtre (APHP); 🇫🇷 Paris, France

CHU Limoges; 🇫🇷 Limoges, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

CHU Montpellier; 🇫🇷 Montpellier, France

Fondation Ophtalmologique Rotschild; 🇫🇷 Paris, France

La Pitié-Salpétrière (APHP); 🇫🇷 Paris, France

CHU Nancy; 🇫🇷 Nancy, France

CHU Rennes; 🇫🇷 Rennes, France

Lariboisière (APHP); 🇫🇷 Paris, France

Hôpital Foch; 🇫🇷 Suresnes, France

CHU Nantes; 🇫🇷 Nantes, France