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

F

Fondation Ophtalmologique Adolphe de Rothschild

Status and phase

Completed
Phase 2

Conditions

Ischemic Stroke

Treatments

Drug: Administration of dornase alfa

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT04785066
JDS_2021_5

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

39 participants in 1 patient group

Study treatment
Experimental group
Description:
Administration of dornase alfa during intervention of thrombectomy
Treatment:
Drug: Administration of dornase alfa

Trial contacts and locations

1

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Central trial contact

Amélie Yavchitz; Jean-Philippe DESILLES

Data sourced from clinicaltrials.gov

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