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

NCT ID: NCT04785066

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-19
• Study Completion Date: 2025-08-18

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study treatment

Administration of dornase alfa during intervention of thrombectomy

Group Type: EXPERIMENTAL

Administration of dornase alfa

Intervention Type: DRUG

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

Interventions

Administration of dornase alfa

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Fondation Adolphe de Rothschild

Paris, Paris, France

Countries

France

Other Identifiers

JDS_2021_5

Identifier Type: -

Identifier Source: org_study_id