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Efficacy of Pulmozyme® on Arterial Recanalization in Post-thrombectomy Patients Managed for Ischemic Stroke (NETs-target) (NETs-target)

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ClinicalTrials.gov Identifier: NCT04785066
Recruitment Status : Recruiting
First Posted : March 5, 2021
Last Update Posted : August 28, 2023
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Study Description
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Brief Summary:

The functional prognosis of patients with ischaemic stroke treated by thrombolysis and thrombectomy is associated with complete reperfusion of the occluded artery defined by an mTICI 2C or 3 score at the end of thrombectomy. However, this complete reperfusion is only obtained in 60% of patients. Most often, incomplete reperfusion is due to the persistence of distal occlusions, which are inaccessible to mechanical thrombectomy. Drug treatment, combined with thrombectomy to increase the rate of complete reperfusion, would be a major advance in the management of these patients.

This is a non-randomized, monocentric, open-label, phase II trial to evaluate efficacy of dornase alfa intravenous administration in patients treated with intravenous thrombolysis and eligible for thrombectomy for ischemic stroke of the anterior circulation.


Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Administration of dornase alfa Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Dornase Alfa (Pulmozyme®) on Arterial Recanalization in Post-thrombectomy Angiography in Patients With Ischemic Stroke by Thrombolysis and Eligible for Thrombectomy (NETs-target)
Actual Study Start Date : August 19, 2022
Estimated Primary Completion Date : August 18, 2025
Estimated Study Completion Date : November 18, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Experimental: Study treatment
Administration of dornase alfa during intervention of thrombectomy
 Drug: Administration of dornase alfa
Patient treated for a cerebral thrombectomy will be administred dornase alfa treatment by intravenous


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the efficacy of intravenous administration of dornase alfa (Pulmozyme®) on arterial recanalization in post-thrombectomy patients managed for ischemic stroke [ Time Frame: 3 months after procedure ]

    Complete recanalization defined by a modified treatment in cerebral infarction (mTICI) 2C or 3 score at cerebral angiography one hour after the start of pulmozyme administration or at the end of the thrombectomy procedure (if procedure >1h).

    • The grade 2C corresponds to : Near complete perfusion except for slow flow in a few distal cortical vessels, or presence of small distal cortical emboli.
    • The grade 3 corresponds to: complete antegrade reperfusion of the previously occluded target artery ischemic territory, with absence of visualized occlusion in all distal branches


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ischemic stroke by proximal intracranial occlusion (internal carotid artery, middle cerebral artery in its M1 or M2 segment) isolated from the anterior circulation eligible for cerebral thrombectomy.
  • Transferred to the NRI block for a cerebral thrombectomy.
  • Treated by thrombolysis intravenous (Aleplase or Tenecteplase) as recommanded by European stroke organisation
  • With DWI-ASPECT score>5 to MRI

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Known allergy to Dornase alfa or one of its excipients.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04785066


Contacts
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Contact: Jean-Philippe DESILLES 0148036454 jpdesilles@for.paris
Contact: Amélie Yavchitz 0148036454 ayavchitz@for.paris

Locations
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France
Hôpital Fondation Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Amélie YAVCHITZ, MD, PhD    +33 1 48 03 64 54    ayavchitz@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
More Information
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT04785066    
Other Study ID Numbers: JDS_2021_5
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: August 28, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis