Acute Distal Vessel Occlusion StrokeDISTAL-IVTNCT05635786
Early Recanalization After Intravenous Thrombolysis With Tenecteplase Versus Alteplase in Distal Vessel Occlusion Strokes
An observational study of Acute Distal Vessel Occlusion Stroke, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The purpose of this monocentric retrospective study is to compare, in patients with acute distal vessel occlusion stroke, the early rates of successful recanalization in patients treated with Alteplase (ALT) versus Tenecteplase (TNK), based on a retrospective analysis of magnetic resonance imaging (MRI) performed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Distal Vessel Occlusion Stroke
- What is being tested?
- Alteplase (0.9mg/kg) and Tenecteplase (0.25mg/kg)
- Type of treatment
- Injection or infusion
- How many people
- 319 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2023to 21 Nov 2024
- Phase
- Observational
- 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
Study population: This is a monocentric retrospective study (Sud-Francilien Hospital (SFH), Corbeil-Essonnes, France) based on a stroke registry prospectively gathered. From March 2016 to February 2020, consecutive patients with acute ischemic stroke (AIS) assessed on brain MRI and treated with IVT alone who fulfilled the following criteria will be included: 18 years or older; evidence of an AIS on acute MRI (MRI-1) associated with a distal vessel occlusion as defined below; IVT within 4h30 of symptoms onset; availability of a post-IVT MRI within 1-2 hours (MRI-2); good quality of MRI sets including SWAN images.
Who may be able to join
- Age≥ 18 years.
- Acute ischemic stroke (visible on DWI, but not visible on FLAIR) on initial MRI associated with distal arterial occlusion as defined below:
- A distal occlusion of the M2 segment of the middle cerebral artery (MCA)
- Occlusion (regardless of location) of a non-dominant M2 branch of the MCA
- Occlusion of the M3 segment of the MCA.
- Occlusion of the A2 or A3 segment of the anterior cerebral artery (ACA)
Show all 12Show fewer
- Occlusion of the P2 or P3 branch of the posterior cerebral artery (PCA).
- A proximal M2-MCA or proximal P1-PCA occlusion may also be included if not eligible for mechanical thrombectomy, especially if the initial NIHSS score is low (<5).
- Distal arterial occlusion is identified by MRI either on the TOF (Time of Flight)-ARM sequence and/or on the presence of a thrombus (Susceptibility Vessel sign, SVS) on the SWAN sequence,
- IVT by ALT or TNK within 4H30 after onset of symptoms,
- Early brain MRI performed 1 to 2 hours after IVT (MRI n°2),
- Good quality MRI (absence of motion artifact interfering with interpretation) with availability of DWI, FLAIR, TOF-MRA and SWAN sequences.
Who cannot join
- Patients informed of the study who objected to the collection of their data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Successful Recanalization After Intravenous Thrombolysis With Tenecteplase Versus Alteplase in Distal Vessel Occlusion Strokes
The purpose of this monocentric retrospective study is to compare, in patients with acute distal vessel occlusion stroke, the early rates of successful recanalization in patients treated with Alteplase (ALT) versus Tenecteplase (TNK), based on a retrospective analysis of magnetic resonance imaging (MRI) performed early after IVT.
Read the detailed description
Early rates of successful recanalization (SR) of distal vessel occlusions (DVO) following intravenous thrombolysis (IVT) between alteplase (ALT) and tenecteplase (TNK) are poorly known.
From March 2016 to February 2020, consecutive stroke patients hospitalized in the stroke unit of the Sud-Francilien Hospital with DVO identified on baseline MRI and suitable for IVT but not for mechanical thrombectomy will be included. In our stroke unit, patients were treated with ALT, 0.9 mg/kg from March 2016 to February 2018 and then with TNK, 0.25 mg/kg from March 2018 to December 2023. MRI was controlled 1-2 hours within IVT (MRI-2). Early recanalization was assessed on an adapted Arterial Occlusion Lesion (AOL) scale, SR being defined as AOL 2/3 scores on MRI-2. The rate reduction of thrombus length (TL) when thrombus persisted, the IVT response threshold of TL and the infarct size evolution were also assessed. In the present study, the investigators sought to compare early rates of SR between the two lytics, based on a retrospective analysis of magnetic resonance imaging (MRI) performed early after IVT.
- Conditions
- Acute Distal Vessel Occlusion Stroke
- Being tested
- Alteplase (0.9mg/kg), Tenecteplase (0.25mg/kg)
- Keywords
- Acute, occlusion, recanalization, tenecteplase, alteplase, thrombolysis, ischemic, stroke-distal
- Medical subject headings
- Bites and Stings, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alteplase (0.9mg/kg)Drug
Intravenous thrombolysis with Alteplase (0.9 mg/kg, maximum 90 mg) with 10% of the dose given as a bolus followed by an infusion lasting 60 minutes.
Tenecteplase (0.25mg/kg)Drug
Intravenous thrombolysis with Tenecteplase (0.25mg/kg, maximum 25 mg) with 100% of the dose given as a bolus.
| Study group | Role | What they receive |
|---|---|---|
| Alteplase (ALT) | Patients with distal vessel occlusion stroke treated with alteplase (from March 2016 to February 2018) Receives: Drug: Alteplase (0.9mg/kg) | |
| Tenecteplase (TNK) | Patients with distal vessel occlusion stroke treated with tenecteplase (from March 2018 to February 2020) Receives: Drug: Tenecteplase (0.25mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early successful recanalization rate
Early successful recanalization rate defined by an Arterial Occlusive Lesion (AOL) scale grade 2 or 3 on MRI-2 performed between 1 and 2 hours after IVT.
Measured: Between 1 and 2 hours after IVT
Secondary outcomes (5)
Early complete recanalization rate
Early complete successful recanalization rate defined by an Arterial Occlusive Lesion (AOL) scale grade 3 on MRI-2 performed between 1 and 2 hours after IVT.
Measured: Between 1 and 2 hours after IVT
Thrombus length change
Thrombus length (TL) was approximated by measuring the susceptibility vessel sign (SVS) on the susceptibility weight angiography (SWAN) sequence.
TL were measured in the 3 spatial planes, the higher value being retained. When thrombus persisted on MRI-2, TL reduction was assessed as follows : (MRI-1 length - MRI-2 length)/MRI-1 length X 100.
Measured: Between 1 and 2 hours after IVT
Evolution of cerebral infarct volume
Volume of the ischemic lesion will be assessed on the diffusion-weighted imaging (DWI) sequence using an automated software (Olea software).
This evolution of cerebral infarct volume will be calculated as follows : DWI MRI volume n°2 - initial DWI MRI volume.
Measured: Between 1 and 2 hours after IVT
Rates of early post-thrombolysis intracerebral hemorrhage
Rates of early post-thrombolysis intracerebral hemorrhage on MRI-2 (performed at 1 to 2h after IVT) according to the Heidelberg classification (Kummer et al, Stroke 2015)
Measured: Between 1 and 2 hours after IVT
Very early clinical modification
Very early neurological modification was assessed as follows : baseline NIHSS -NIHSS at H1.
Very early clinical improvement (VENI) was defined as baseline NIHSS -NIHSS at H1. ≥4, or NIHSS H1=0.
Measured: Between 1 and 2 hours after IVT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start2 Jan 2023
- Primary completion21 Nov 2024
- Study completion21 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Distal Vessel Occlusion StrokeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635786
- Sponsor's protocol ID
- 2022/0037
- Acronym
- DISTAL-IVT
- Status last verified
- Mar 2025
- First submitted
- 23 Nov 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chausson N, Benzakoun J, Vargas-Ibarra S, L'Hermitte Y, Ben Hassen W, Smadja D, Turc G. Early Recanalization After Tenecteplase or Alteplase in Distal and Medium Vessel Occlusion Strokes: An Observational Cohort Study. Stroke. 2026 Sep 10. doi: 10.1161/STROKEAHA.125.054734. Online ahead of print.
PubMed 42717910
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Successful Recanalization After Intravenous Thrombolysis With Tenecteplase Versus Alteplase in Distal Vessel Occlusion Strokes
- ClinicalTrials.gov ID
- NCT05635786
- Acronym / sponsor ID
- DISTAL-IVT / 2022/0037
- Conditions
- Acute Distal Vessel Occlusion Stroke
- Keywords
- Acute, occlusion, recanalization, tenecteplase, alteplase, thrombolysis, ischemic, stroke-distal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 21 Nov 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 2 Dec 2022 (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 purpose of this monocentric retrospective study is to compare, in patients with acute distal vessel occlusion stroke, the early rates of successful recanalization in patients treated with Alteplase (ALT) versus Tenecteplase (TNK), based on a retrospective analysis of magnetic resonance imaging (MRI) performed early after IVT.
Detailed description
Early rates of successful recanalization (SR) of distal vessel occlusions (DVO) following intravenous thrombolysis (IVT) between alteplase (ALT) and tenecteplase (TNK) are poorly known.
From March 2016 to February 2020, consecutive stroke patients hospitalized in the stroke unit of the Sud-Francilien Hospital with DVO identified on baseline MRI and suitable for IVT but not for mechanical thrombectomy will be included. In our stroke unit, patients were treated with ALT, 0.9 mg/kg from March 2016 to February 2018 and then with TNK, 0.25 mg/kg from March 2018 to December 2023. MRI was controlled 1-2 hours within IVT (MRI-2). Early recanalization was assessed on an adapted Arterial Occlusion Lesion (AOL) scale, SR being defined as AOL 2/3 scores on MRI-2. The rate reduction of thrombus length (TL) when thrombus persisted, the IVT response threshold of TL and the infarct size evolution were also assessed. In the present study, the investigators sought to compare early rates of SR between the two lytics, based on a retrospective analysis of magnetic resonance imaging (MRI) performed early after IVT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alteplase (ALT) | – | Drug: Alteplase (0.9mg/kg)Patients with distal vessel occlusion stroke treated with alteplase (from March 2016 to February 2018) |
| Tenecteplase (TNK) | – | Drug: Tenecteplase (0.25mg/kg)Patients with distal vessel occlusion stroke treated with tenecteplase (from March 2018 to February 2020) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a monocentric retrospective study (Sud-Francilien Hospital (SFH), Corbeil-Essonnes, France) based on a stroke registry prospectively gathered. From March 2016 to February 2020, consecutive patients with acute ischemic stroke (AIS) assessed on brain MRI and treated with IVT alone who fulfilled the following criteria will be included: 18 years or older; evidence of an AIS on acute MRI (MRI-1) associated with a distal vessel occlusion as defined below; IVT within 4h30 of symptoms onset; availability of a post-IVT MRI within 1-2 hours (MRI-2); good quality of MRI sets including SWAN images.
Key inclusion criteria (12 listed)
- Age≥ 18 years.
- Acute ischemic stroke (visible on DWI, but not visible on FLAIR) on initial MRI associated with distal arterial occlusion as defined below:
- IVT by ALT or TNK within 4H30 after onset of symptoms,
- Early brain MRI performed 1 to 2 hours after IVT (MRI n°2),
- Good quality MRI (absence of motion artifact interfering with interpretation) with availability of DWI, FLAIR, TOF-MRA and SWAN sequences.
Key exclusion criteria (1 listed)
- Patients informed of the study who objected to the collection of their data.
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 |
|---|---|---|
| Alteplase (0.9mg/kg)Intravenous thrombolysis with Alteplase (0.9 mg/kg, maximum 90 mg) with 10% of the dose given as a bolus followed by an infusion lasting 60 minutes. | Drug | Alteplase (ALT) |
| Tenecteplase (0.25mg/kg)Intravenous thrombolysis with Tenecteplase (0.25mg/kg, maximum 25 mg) with 100% of the dose given as a bolus. | Drug | Tenecteplase (TNK) |
Primary outcome
Early successful recanalization rate
Time frame: Between 1 and 2 hours after IVT
Early successful recanalization rate defined by an Arterial Occlusive Lesion (AOL) scale grade 2 or 3 on MRI-2 performed between 1 and 2 hours after IVT.
5 secondary outcomes
Early complete recanalization rate
Time frame: Between 1 and 2 hours after IVT
Thrombus length change
Time frame: Between 1 and 2 hours after IVT
Evolution of cerebral infarct volume
Time frame: Between 1 and 2 hours after IVT
Rates of early post-thrombolysis intracerebral hemorrhage
Time frame: Between 1 and 2 hours after IVT
Very early clinical modification
Time frame: Between 1 and 2 hours after IVT
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 13 Mar 2025.
- Derived from this study: PubMed 42717910Chausson N, Benzakoun J, Vargas-Ibarra S, L'Hermitte Y, Ben Hassen W, Smadja D, Turc G. Early Recanalization After Tenecteplase or Alteplase in Distal and Medium Vessel Occlusion Strokes: An Observational Cohort Study. Stroke. 2026 Sep 10. doi: 10.1161/STROKEAHA.125.054734. Online ahead of print.
- Individual participant dataSharing planned: No
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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?
An observational study of Acute Distal Vessel Occlusion Stroke, run by Centre Hospitalier Sud Francilien 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 12 inclusion and 1 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 13 Mar 2025. 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.
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?
Early successful recanalization rate (time frame: Between 1 and 2 hours after IVT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05635786, which also lists 1 linked publication.
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 13 Mar 2025.