Recruiting NCT07367100
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adaptive Tip Catheter.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, France, Germany, Ireland, Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, First in Human Pivotal Study to Evaluate the Adaptive Tip Catheter Used to Treat Acute Ischemic Stroke Patients During Mechanical Thrombectomy
Overview
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.
Interventions
- Procedure Adaptive Tip Catheter
Patients will undergo mechanical thrombectomy using ATC.
Primary outcome measures
- Third Pass Reperfusion Assessed by Independent Imaging Core Lab [Time frame: Intraoperative]
Secondary outcome measures (6)
- First Pass Reperfusion [Time frame: Intraoperative]
- Final Procedural Reperfusion [Time frame: Intraoperative]
- Modified Rankin Scale (mRS) Score of 0-2 at 90 days Post-Procedure [Time frame: At 90 days post-procedure]
- Vessel Damage [Time frame: At 90 days post-procedure]
- All-Cause Mortality [Time frame: At 90 days post-procedure]
- Symptomatic Intracranial Hemorrhage (sICH) at 24 hours [Time frame: At 24 hours after intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 5 centers
- CHU Bordeaux — Bordeaux
- CHU Nantes — Nantes
- CHU Pitie Salpetriere — Paris
- Centre Hospitalier Universitaire de Toulouse - Hopital Purpan — Toulouse
- CHRU de Tours — Tours
Germany · 4 centers
- Universitaetsklinikum Heidelberg — Heidelberg
- Universitatsklinikum Schleswig Holstein Kiel — Kiel
- Universitaetsmedizin Mainz — Mainz
- Stadtisches Klinikum Solingen gemeinnutzige GmbH — Solingen
Belgium · 3 centers
- UZ Antwerpen — Edegem
- Ghent University Hospital — Ghent
- Universitair Ziekenhuis Leuven — Leuven
Netherlands · 2 centers
- VUMC Amsterdam — Amsterdam
- Maastricht University Medical Centre — Maastricht
Ireland · 1 center
- Beaumont Hospital — Dublin
Identifiers
NCT: NCT07367100 · CNV202304