En afgørende undersøgelse, der evaluerer sikkerheden og effektiviteten af en adaptiv tipkateter hos patienter med akut iskæmisk apopleksi (PHAST)
Et prospektivt, første-in-human-pivotstudie til evaluering af den adaptive tipkateter, der bruges til behandling af patienter med akut iskæmisk apopleksi under mekanisk trombetomi
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Adriana Popovici
- Telefonnummer: +41 76 396 34 66
- E-mail: apopovi3@its.jnj.com
Undersøgelse Kontakt Backup
- Navn: Arnaud Nicolas, PhD
- Telefonnummer: +41 79 517 97 36
- E-mail: anicolas@its.jnj.com
Studiesteder
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Edegem, Belgien, 2650
- Rekruttering
- UZ Antwerpen
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Ghent, Belgien, 9000
- Rekruttering
- Ghent University Hospital
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Leuven, Belgien, 3000
- Rekruttering
- Universitair Ziekenhuis Leuven
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Bordeaux, Frankrig, 33076
- Rekruttering
- CHU Bordeaux
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Toulouse, Frankrig, 31059
- Rekruttering
- Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
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Tours, Frankrig, 37000
- Rekruttering
- CHRU de Tours
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Heidelberg, Tyskland, 69120
- Rekruttering
- Universitaetsklinikum Heidelberg
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Kiel, Tyskland, 24105
- Rekruttering
- Universitatsklinikum Schleswig Holstein Kiel
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Mainz, Tyskland, 55101
- Rekruttering
- Universitaetsmedizin Mainz
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Solingen, Tyskland, 42653
- Rekruttering
- Stadtisches Klinikum Solingen gemeinnutzige GmbH
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Third Pass Reperfusion Assessed by Independent Imaging Core Lab
Tidsramme: Intraoperative
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
First Pass Reperfusion
Tidsramme: Intraoperative
|
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
Tidsramme: Intraoperative
|
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
Tidsramme: 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
Tidsramme: At 90 days post-procedure
|
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
Tidsramme: At 90 days post-procedure
|
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
Tidsramme: At 24 hours after intervention
|
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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Christophe Cognard, MD-PhD, CHU Toulouse - Hôpital, Purpan, Toulouse France
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CNV202304
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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