Ischemic StrokePhase 2NETs-targetNCT04785066
Efficacy of Pulmozyme® on Arterial Recanalization in Post-thrombectomy Patients Managed for Ischemic Stroke (NETs-target)
A Phase 2 study testing Administration of dornase alfa in people with Ischemic Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Administration of dornase alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 19 Aug 2022to 30 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant or breastfeeding woman
- Known allergy to Dornase alfa or one of its excipients.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- Administration of dornase alfa
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of dornase alfaDrug
Patient treated for a cerebral thrombectomy will be administred dornase alfa treatment by intravenous
| Study group | Role | What they receive |
|---|---|---|
| Study treatment | Experimental | Administration of dornase alfa during intervention of thrombectomy Receives: Drug: Administration of dornase alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start19 Aug 2022
- Primary completion18 Aug 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785066
- Sponsor's protocol ID
- JDS_2021_5
- Acronym
- NETs-target
- Status last verified
- Jan 2026
- First submitted
- 23 Feb 2021
- Last updated
- 22 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04785066
- Acronym / sponsor ID
- NETs-target / JDS_2021_5
- Conditions
- Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study treatment | Experimental | Drug: Administration of dornase alfaAdministration of dornase alfa during intervention of thrombectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding woman
- Known allergy to Dornase alfa or one of its excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of dornase alfaPatient treated for a cerebral thrombectomy will be administred dornase alfa treatment by intravenous | Drug | Study treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Administration of dornase alfa in people with Ischemic Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.