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

Ischemic Stroke Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04785066
• Other study ID #: JDS_2021_5
• Status: Recruiting
• Phase: Phase 2
• Start date: August 19, 2022
• Est. completion date: November 18, 2025

Study information

• Verified date: July 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Jean-Philippe DESILLES
• Phone: 0148036454
• Email: jpdesilles[@]for.paris
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: November 18, 2025
• Est. primary completion date: August 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Administration of dornase alfa
Patient treated for a cerebral thrombectomy will be administred dornase alfa treatment by intravenous

Locations

Country	Name	City	State
France	Hôpital Fondation Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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