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

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Administration of dornase alfa
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital Fondation Adolphe de RothschildRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study treatment

Arm Description

Administration of dornase alfa during intervention of thrombectomy

Outcomes

Primary Outcome Measures

Evaluate the efficacy of intravenous administration of dornase alfa (Pulmozyme®) on arterial recanalization in post-thrombectomy patients managed for ischemic stroke
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

Secondary Outcome Measures

Full Information

First Posted
February 23, 2021
Last Updated
August 25, 2023
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT04785066
Brief Title
Efficacy of Pulmozyme® on Arterial Recanalization in Post-thrombectomy Patients Managed for Ischemic Stroke (NETs-target)
Acronym
NETs-target
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2022 (Actual)
Primary Completion Date
August 18, 2025 (Anticipated)
Study Completion Date
November 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study treatment
Arm Type
Experimental
Arm Description
Administration of dornase alfa during intervention of thrombectomy
Intervention Type
Drug
Intervention Name(s)
Administration of dornase alfa
Intervention Description
Patient treated for a cerebral thrombectomy will be administred dornase alfa treatment by intravenous
Primary Outcome Measure Information:
Title
Evaluate the efficacy of intravenous administration of dornase alfa (Pulmozyme®) on arterial recanalization in post-thrombectomy patients managed for ischemic stroke
Description
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
Time Frame
3 months after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Philippe DESILLES
Phone
0148036454
Email
jpdesilles@for.paris
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie Yavchitz
Phone
0148036454
Email
ayavchitz@for.paris
Facility Information:
Facility Name
Hôpital Fondation Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amélie YAVCHITZ, MD, PhD
Phone
+33 1 48 03 64 54
Email
ayavchitz@for.paris

12. IPD Sharing Statement

Learn more about this trial

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

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