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The purpose of this study is to assess the safety and the effectiveness of the Adaptive Tip Catheter (ATC) used as a first line direct aspiration thrombectomy technique for patients suffering of an acute ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive Tip Catheter (ATC) | Experimental | The ATC will be used alone (direct aspiration) as the first attempted device/technique for mechanical thrombectomy in the anterior circulation in patients during the first three passes or until final reperfusion, if less than three passes are needed. Patients will be followed over 90 days post procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive Tip Catheter | Procedure | Patients will undergo mechanical thrombectomy using ATC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Third Pass Reperfusion Assessed by Independent Imaging Core Lab | Successful achievement of the third pass reperfusion is defined as achieving an Expanded Thrombolysis in Cerebral Infarction (eTICI) score of 2b50 or greater using no more than three passes with the study device in the target vessel, and without any rescue therapy. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| First Pass Reperfusion | Successful achievement of the first pass reperfusion is defined as achieving an eTICI score of 2c or greater, as determined by the independent imaging core lab, with one pass of the study device in the target vessel, and without any rescue therapy. | Intraoperative |
| Final Procedural Reperfusion |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adriana Popovici | Contact | +41 76 396 34 66 | apopovi3@its.jnj.com | |
| Arnaud Nicolas, PhD | Contact | +41 79 517 97 36 | anicolas@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Christophe Cognard, MD-PhD | CHU Toulouse - Hôpital, Purpan, Toulouse France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Antwerpen | Recruiting | Edegem | 2650 | Belgium | ||
| Ghent University Hospital |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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Successful achievement of the final procedural reperfusion is defined as achieving a final (end of procedure) eTICI score of 2b50 or greater in the target vessel as determined by the independent imaging core lab. |
| Intraoperative |
| Modified Rankin Scale (mRS) Score of 0-2 at 90 days Post-Procedure | Percentage of patients with mRS score of 0-2 at 90 days or no change from baseline if pre-ictal mRS greater than (>) 2 will be reported. | At 90 days post-procedure |
| Vessel Damage | Number of patients with perforation or dissection in the blood vessel known to be related to or possibly related to the study device will be reported. | At 90 days post-procedure |
| All-Cause Mortality | All mortality regardless of causes at 90 days post-procedure will be reported. | At 90 days post-procedure |
| Symptomatic Intracranial Hemorrhage (sICH) at 24 hours | sICH is defined as a new intracranial hemorrhage as detected by brain imaging, measured 24 hours after intervention associated with any of the following: greater than or equal to (>=) 4 points total National Institutes of Health Stroke Scale (NIHSS) at the time of diagnosis compared to immediately before worsening; >= 2 point in one NIHSS category; leading to intubation/hemicraniectomy/external ventricular drain (EVD) placement or other major medical/surgical intervention or absence of alternative explanation for deterioration. | At 24 hours after intervention |
| Recruiting |
| Ghent |
| 9000 |
| Belgium |
| Universitair Ziekenhuis Leuven | Recruiting | Leuven | 3000 | Belgium |
| CHU Bordeaux | Not yet recruiting | Bordeaux | 33076 | France |
| CHU Nantes | Not yet recruiting | Nantes | 44093 | France |
| CHU Pitie Salpetriere | Not yet recruiting | Paris | 75013 | France |
| Centre Hospitalier Universitaire de Toulouse - Hopital Purpan | Recruiting | Toulouse | 31059 | France |
| CHRU de Tours | Not yet recruiting | Tours | 37000 | France |
| Universitaetsklinikum Heidelberg | Not yet recruiting | Heidelberg | 69120 | Germany |
| Universitatsklinikum Schleswig Holstein Kiel | Recruiting | Kiel | 24105 | Germany |
| Universitaetsmedizin Mainz | Recruiting | Mainz | 55101 | Germany |
| Stadtisches Klinikum Solingen gemeinnutzige GmbH | Recruiting | Solingen | 42653 | Germany |
| Beaumont Hospital | Not yet recruiting | Dublin | 00000 | Ireland |
| VUMC Amsterdam | Withdrawn | Amsterdam | 1105 AZ | Netherlands |
| Maastricht University Medical Centre | Not yet recruiting | Maastricht | 6229 HX | Netherlands |
| 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 |
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