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

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

Tracking Information

• First Submitted Date: February 23, 2021
• First Posted Date: March 5, 2021
• Last Update Posted Date: August 28, 2023
• Actual Study Start Date: August 19, 2022
• Estimated Primary Completion Date: August 18, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 3, 2021)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Pulmozyme® on Arterial Recanalization in Post-thrombectomy Patients Managed for Ischemic Stroke (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)

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Ischemic Stroke

Intervention

Drug: Administration of dornase alfa

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

Study Arms

Experimental: Study treatment

Administration of dornase alfa during intervention of thrombectomy

Intervention: Drug: Administration of dornase alfa

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 3, 2021): 44
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 18, 2025
• Estimated Primary Completion Date: August 18, 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jean-Philippe DESILLES; 0148036454; jpdesilles@for.paris

Contact: Amélie Yavchitz; 0148036454; ayavchitz@for.paris

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04785066
• Other Study ID Numbers: JDS_2021_5
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• Original Responsible Party: Same as current
• Current Study Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Fondation Ophtalmologique Adolphe de Rothschild
• Verification Date: July 2023