Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01735-46 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined use of contact aspiration and stent retriever | Experimental | Combined use of contact aspiration and stent retriever mechanical thrombectomy for recanalization |
|
| Stent retriever mechanical thrombectomy alone | Active Comparator | Stent retriever mechanical thrombectomy alone for recanalisation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Perfect reperfusion rate | 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) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful reperfusion | Rate of successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) at end of endovascular procedure | 24 hours |
| Rate of perfect (mTICI 2c/3), successful reperfusion (mTICI 2b/2c/3), and complete reperfusion (mTICI3) after the frontline strategy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bertrand Lapergue, MD | Hôpital Foch | Principal Investigator |
| Michel Piotin, MD | Fondation Ophtalmologique de Rothschild | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Bordeaux | France | ||||
| CHU Limoges |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38126181 | Derived | Sgreccia A, Desilles JP, Costalat V, Dargazanli C, Bourcier R, Tessier G, Rouchaud A, Saleme S, Spelle L, Caroff J, Marnat G, Barreau X, Clarencon F, Shotar E, Eugene F, Houdart E, Gory B, Zhu F, Labreuche J, Piotin M, Lapergue B, Consoli A; ASTER2 Investigators. Combined Technique for Internal Carotid Artery Terminus or Middle Cerebral Artery Occlusions in the ASTER2 Trial. Stroke. 2024 Feb;55(2):376-384. doi: 10.1161/STROKEAHA.123.045227. Epub 2023 Dec 21. | |
| 34581737 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 24 hours |
| Time from groin puncture to achieve TICI 2c or better revascularization | Time from groin puncture to achieve TICI 2c or better revascularization | 24 hours |
| Time between groin puncture to clot contact and clot contact to maximum reperfusion | Time between groin puncture to clot contact and clot contact to maximum reperfusion | 24 hours |
| Modified Rankin scale (mRs) | Global disability assessed by overall distribution of mRs at 90-days | 90 days |
| Rate of favorable functional independence | Rate of favorable functional independence defined as a mRS 0-2 at 90 days | 90 days |
| Rate of excellent functional outcome | Rate of excellent functional outcome defined as a Modified Rankin scale (mRS) 0-1 at 90 days | 90 days |
| NIHSS score | Change in NIHSS from baseline to 24 hours (delta NIHSS) | 24 hours |
| Rate of symptomatic and asymptomatic intracerebral hemorrhage | 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). | 24 hours |
| Rate of parenchymal hematoma | 90 days |
| Rate of all-cause mortality | 90 days |
| Rate of periprocedural complications | - Rate of periprocedural complications: Occurrence of emboli to new territory (ENT), vasospasm, dissection, or perforation. | 90 days |
| Average cost per patient | Average cost per patient with complete recanalization | 90 days |
| Limoges |
| France |
| CHU Montpellier | Montpellier | France |
| CHU Nancy | Nancy | France |
| CHU Nantes | Nantes | France |
| Fondation Ophtalmologique Rotschild | Paris | 75019 | France |
| Kremlin-Bicêtre (APHP) | Paris | France |
| La Pitié-Salpétrière (APHP) | Paris | France |
| Lariboisière (APHP) | Paris | France |
| CHU Rennes | Rennes | France |
| Hôpital Foch | Suresnes | 92150 | France |
| Derived |
| Lapergue B, Blanc R, Costalat V, Desal H, Saleme S, Spelle L, Marnat G, Shotar E, Eugene F, Mazighi M, Houdart E, Consoli A, Rodesch G, Bourcier R, Bracard S, Duhamel A, Ben Maacha M, Lopez D, Renaud N, Labreuche J, Gory B, Piotin M; ASTER2 Trial Investigators. Effect of Thrombectomy With Combined Contact Aspiration and Stent Retriever vs Stent Retriever Alone on Revascularization in Patients With Acute Ischemic Stroke and Large Vessel Occlusion: The ASTER2 Randomized Clinical Trial. JAMA. 2021 Sep 28;326(12):1158-1169. doi: 10.1001/jama.2021.13827. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided