Een cruciaal onderzoek naar de veiligheid en effectiviteit van de Adaptative Tip-katheter bij patiënten met een acuut ischemisch beroerte (PHAST)
Een prospectieve, eerste in mens-pivotale studie om de adaptieve tipkatheter te evalueren die wordt gebruikt om patiënten met acuut ischemisch herseninfarct te behandelen tijdens mechanische trombectomie
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Adriana Popovici
- Telefoonnummer: +41 76 396 34 66
- E-mail: apopovi3@its.jnj.com
Studie Contact Back-up
- Naam: Arnaud Nicolas, PhD
- Telefoonnummer: +41 79 517 97 36
- E-mail: anicolas@its.jnj.com
Studie Locaties
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Edegem, België, 2650
- Werving
- UZ Antwerpen
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Ghent, België, 9000
- Werving
- Ghent University Hospital
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Leuven, België, 3000
- Werving
- Universitair Ziekenhuis Leuven
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Heidelberg, Duitsland, 69120
- Werving
- Universitaetsklinikum Heidelberg
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Kiel, Duitsland, 24105
- Werving
- Universitatsklinikum Schleswig Holstein Kiel
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Mainz, Duitsland, 55101
- Werving
- Universitaetsmedizin Mainz
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Solingen, Duitsland, 42653
- Werving
- Stadtisches Klinikum Solingen gemeinnutzige GmbH
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Bordeaux, Frankrijk, 33076
- Werving
- CHU Bordeaux
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Nantes, Frankrijk, 44093
- Werving
- CHU Nantes
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Paris, Frankrijk, 75013
- Werving
- CHU Pitie Salpetriere
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Toulouse, Frankrijk, 31059
- Werving
- Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
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Tours, Frankrijk, 37000
- Werving
- CHRU de Tours
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Dublin, Ierland, 00000
- Werving
- Beaumont Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion criteria:
- Age greater than or equal to (>=) 18 years, less than or equal to (<=) 90 years, at the time of consent
- Signs and symptoms consistent with the diagnosis of acute ischemic stroke in the anterior circulation that can be treated with endovascular thrombectomy approaches
- Endovascular treatment can be initiated (defined as access puncture) within 24 hours from time last known well
- Baseline National Institutes of Health Stroke Scale (NIHSS) score >= 6
- Baseline Alberta Stroke Program Early CT Score (ASPECTS) >= 3
- A signed and dated Informed Consent Form (ICF) or Investigator Statement for emergency procedure (as allowed according to country regulations and approved by EC) has been obtained
Exclusion criteria:
- Known pregnancy, as evidenced by positive pregnancy test for women of childbearing potential or breast feeding
- Life expectancy less than (<) 90 days prior to stroke onset
- Known hemorrhagic diathesis disorder, coagulation factor deficiency or oral anticoagulant therapy with known International Normalized Ratio (INR) greater than (>) 3.0
- Clinical symptoms and/or CT/MRI evidence suggestive of bilateral stroke or stroke in multiple vascular territories, defined as occlusions in more than one vessel not downstream from each other (for example, bilateral anterior circulation, anterior/posterior circulation)
- Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic
- Computed Tomography/ Magnetic Resonance Imaging (CT/MRI) evidence of recent/fresh hemorrhage
- Baseline CT or MRI showing mass effect
- Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible
- Cerebral catheter angiographic evidence of pre-existing arterial disease, that potentially impacts treatment and/or outcome (for example, vasculitis)
- Any occlusion or stenosis that limits device access to the target area (for example, carotid dissection, tandem occlusions) or requiring acute stenting to achieve access
- Cerebral catheter angiographic evidence of multiple cerebrovascular occlusions, defined as occlusions in more than one vessel not downstream from each other (for example, bilateral anterior circulation, anterior/posterior circulation)
- Excessive vascular access tortuosity that will likely prevent endovascular access with the adaptive tip catheter (ATC)
- Baseline expanded thrombolysis in cerebral infarction (eTICI) > 1
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Adaptive Tip Catheter (ATC)
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. |
Patients will undergo mechanical thrombectomy using ATC. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Third Pass Reperfusion Assessed by Independent Imaging Core Lab
Tijdsspanne: Intraoperative
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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First Pass Reperfusion
Tijdsspanne: Intraoperative
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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
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Final Procedural Reperfusion
Tijdsspanne: Intraoperative
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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
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Modified Rankin Scale (mRS) Score of 0-2 at 90 days Post-Procedure
Tijdsspanne: At 90 days post-procedure
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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
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Vessel Damage
Tijdsspanne: At 90 days post-procedure
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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
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All-Cause Mortality
Tijdsspanne: At 90 days post-procedure
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All mortality regardless of causes at 90 days post-procedure will be reported. |
At 90 days post-procedure
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Symptomatic Intracranial Hemorrhage (sICH) at 24 hours
Tijdsspanne: At 24 hours after intervention
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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
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Christophe Cognard, MD-PhD, CHU Toulouse - Hôpital, Purpan, Toulouse France
Studie record data
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Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
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Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CNV202304
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
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