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

NCT04785066 | Completed Phase 2

• 1 other identifier: JDS_2021_5
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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

  3 months after procedure

Study Arms (1)

Study treatment

EXPERIMENTAL

Administration of dornase alfa during intervention of thrombectomy

Drug: Administration of dornase alfa

Interventions

Administration of dornase alfa DRUG

Patient treated for a cerebral thrombectomy will be administred dornase alfa treatment by intravenous

Study treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding woman
• Known allergy to Dornase alfa or one of its excipients.

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation Adolphe de Rothschild

Paris, Paris, 75019, France

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 5, 2021
• Study Start: August 19, 2022
• Primary Completion: August 18, 2025
• Study Completion: October 30, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

FR (1)