Evaluation of the efficacy of intra venous dornase alfa (Pulmozyme®) on arterial recanalization in post-thrombectomy angiography in patients managed for ischemic stroke with thrombolysis and eligible for thrombectomy: a single-center phase II trial.
- Conditions
- Ischemic strokeMedDRA version: 22.1Level: LLTClassification code: 10055221Term: Ischemic stroke Class: 10029205Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2024-515831-31-00
- Lead Sponsor
- Fondation A De Rothschild
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 44
Patient aged over 18, Ischaemic stroke due to proximal intracranial occlusion (internal carotid artery or middle cerebral artery in its M1 segment) isolated from the anterior circulation eligible for cerebral thrombectomy., Transferred urgently to the NRI unit at the Fondation Adolphe de Rothschild Hospital for cerebral thrombectomy, Treated with intravenous thrombolysis (Alteplase or Tenecteplase) according to the 2021 recommendations of the European Stroke Organisation (ESO) with a bolus performed less than 90 minutes before inclusion, With a DWI-ASPECT score = 5 on initial brain MRI, Having received complete information about the study and having signed a consent to participate in the study (if it is impossible to provide information and to obtain consent to participate from the person undergoing the research, the information and consent must be obtained from the trusted support person or a family member if present; by way of derogation, inclusion may be carried out by the doctor following an emergency inclusion procedure), Member or beneficiary of a social security scheme
Tandem occlusion defined by proximal intracranial occlusion associated with homolateral extracranial stenosis of the internal carotid artery (>90% stenosis or complete occlusion) on initial MRI, Intracranial occlusion with suspected underlying arterial stenosis on initial MRI, mRS score > 2, Patient benefiting from a legal protection measure, Women of childbearing age (15-49), Known allergy to Dornase alfa (Pulmozyme®) or to one of its excipients., Patients included in this study are not allowed to participate in other interventional clinical research, Secondary exclusion criteria: Patients who did not receive the experimental treatment. Excluded patients will be replaced
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method