StrokeDIVERSONCT05930145
Results of the Use of Two Stentrievers Simultaneosly Compared With One as a Primary Treatment in Acute Ischemic Stroke
A study testing Double stentriever and Single stentriever in people with Stroke and Thrombectomy, run by Fundación EPIC at 4 sites in 2 countries.
Trial summary
Several studies have demonstrated that simultaneous treatment with two stentrievers (STs) as rescue treatment is very effective, with high recanalization rates even in this group of patients where other revascularization techniques have failed. There has been no observed increase in hemorrhagic complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Thrombectomy, Arterial Occlusive Diseases
- What is being tested?
- Double stentriever and Single stentriever
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 14 Mar 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- A new disabling focal neurological deficit compatible with acute cerebral ischemia.
- Any age. Informed consent obtained from the patient or representative.
- NIHSS score ≥ 6.
- Pre-existing functional clinical status less than or equal to 2 according to the mRS clinical scale.
- Maximum time of 24 hours from symptom onset to arterial puncture. • TICI 0-1 in the diagnosed TICA (terminal internal carotid artery) , MCA (middle cerebral artery), and BA( basilar artery confirmed by angioCT and angiography).
- ASPECTs score on baseline CT greater than or equal to 6.
- In cases where it is indicated, prior intravenous fibrinolysis will be administered according to the protocols of each center.
Who cannot join
- Those described in the usual protocols for mechanical thrombectomy of each hospital.
- Pre-existing functional clinical status greater than 2 according to the mRS clinical scale
- Patients with tandem lesions of dissection or arteriosclerotic origin located in the extracranial internal carotid artery.
- Initiation of treatment with a different technique than the one described.
- Inability to use a proximal balloon guide catheter.
- Use of aspiration catheter.
Show all 13Show fewer
- Intracranial atherosclerotic plaque as the cause of occlusion.
- Advanced or terminal disease with a life expectancy of less than 6 months.
- Patient who is participating in another study that may affect this one.
- ASPECTS score less than or equal to 6 on baseline CT.
- Evidence of significant hemorrhage or mass effect with midline shift on baseline CT.
- Patients with occlusions in multiple vascular territories.
- Evidence of intracranial tumor (except for small meningiomas)
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario de Cruces
Barakaldo, 48903
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, 33011
- Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
Germany1 site, 1 recruiting
- Recruiting
Alfried Krupp Hospital Ruettenscheid
Essen
About this study
Official title: A Randomized Study Comparing the Effectiveness and Security of the Use of Two Stentrievers Simultaneously Versus One Stentriever as a Primary Treatment in Acute Ischemic Stroke Patients.
Several studies have demonstrated that simultaneous treatment with two stentrievers (STs) as rescue treatment is very effective, with high recanalization rates even in this group of patients where other revascularization techniques have failed. There has been no observed increase in hemorrhagic complications. Recently, a prospective study has been published where treatment with two ST has been shown to be effective and safe if used as a first-choice treatment (not as rescue) with a successful recanalization rate (eTICI 2c/3) after the first pass of 69%. These results have been reinforced after the publication of a randomized study that confirms, in vitro, the superiority of using two ST over one.
Read the detailed description
The use of a double stent retriever has been proposed as a safe and effective technique. The investigators hypothesized that the use of double stentriever primary could lead to higher first pass effect rates and better outcomes compared to single stentriever primary.
Our goal is to develop a research project to provide additional information on the potential benefits of the simultaneous double stent approach primarily in stroke patients receiving endovascular treatment.
A randomized study to compare the efficacy of double primary stentriever versus single primary stentriever.
- Conditions
- Stroke, Thrombectomy, Arterial Occlusive Diseases
- Being tested
- Double stentriever, Single stentriever
- Keywords
- Stroke, Double Stentriever, Thrombectomy
- Medical subject headings
- Stroke, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double stentrieverDevice
Double stentriever technique
Single stentrieverDevice
Single stentriever technique
| Study group | Role | What they receive |
|---|---|---|
| Double stentriever technique | Experimental | Patients treated with thrombectomy with a proximal balloon guiding catheter using two stentrievers simultaneously (one of 6 mm x 50 mm and another of 6 mm x 50 mm or 4 mm x 35 mm) Receives: Device: Double stentriever |
| Single stentriever technique | Active comparator | Patients treated with thrombectomy with a proximal balloon guiding catheter using one stentriever (6 mm x 50 mm). Receives: Device: Single stentriever |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFECTIVENESS OBJECTIVE: Complete recanalization on first pass
Comparison of the complete recanalization rate in the first pass in the double stent group compared to the single stent group, defined as TICI greater than 2c on the Thrombolysis in Cerebral Infarction scale (eTICI scale).
Measured: 90 days
SAFETY OBJECTIVE: Intracerebral hemorrhage.
Rate of patients with symptomatic intracranial hemorrhage (neurological deterioration in National Institutes of Health Stroke Scale [NIHSS] >4) at 24h observed between both groups and, fundamentally, evaluated by CT.
Measured: 24 hours
Secondary outcomes (12)
Intervention success.
Rate of the ability to position both STs in the indicated location.
Measured: During the procedure
Complications related to the intervention.
Evaluation of the rate of arterial perforation, angiographic extravasation of contrast, arterial dissection or arterial vasospasm.
Measured: During the procedure
Embolism in new territories.
Rate of embolization to an artery not involved in the initially affected territory.
Measured: During the procedure
Number of passes with the devices.
Evaluation of the number of passes with the devices during the procedure.
Measured: During the procedure
Procedure time.
Time from arterial puncture to arterial recanalization, or if not achieved, until the end of the intervention.
Measured: During the procedure
Arterial Recanalization (eTICI scale) on first pass.
evaluation of the rates of eTICI 3, eTICI 2c/3, eTICI e2b/3 on the Thrombolysis in Cerebral Infarction scale (e TICI scale); range 0-3, with highest score indicating complete recanalization.
Measured: During the procedure
Arterial recanalization at the end of the procedures.
eTICI 3, eTICI e2c/3, eTICI e2b/3 at the end of the procedure on the Thrombolysis in Cerebral Infarction scale (e TICI scale); range 0-3, with highest score indicating complete recanalization.
Measured: During the procedure
Intracerebral hemorrhage.
Rate of any type of intracranial hemorrhage on the 24-hour control computed tomography (CT) scan (subarachnoid hemorrhage and hemorrhage according to the classification used in the ECASS study).
Measured: 24 hours
Early neurological improvement.
Rate of patients with a decrease of 10 points or more on the NIHSS scale or complete recovery during the first 24 hours. Improvement of Neurological status at 24 hours, determined by National Institutes of Health Stroke Scale [NIHSS score] range 0-42, with higher scores indicating greater stroke severity.
Measured: 24 hours
National Institutes of Health Stroke Scale (NIHSS) scale at 24 hours, on day 5, or at discharge.
Neurological status at 24 hours, at day 5 (+/- 12 hours) or discharge, determined by National Institutes of Health Stroke Scale [NIHSS score] range 0-42, with higher scores indicating greater stroke severity.
Measured: 5 days
Modified Rankin Scale (mRS) scale at 90 days.
Modified Rankin Scale (mRS; range 0 [no symptoms] to 6 [death] for the evaluation of neurological functional disability score at 90 days
Measured: 90 days
Mortality rate.
90-day mortality rate.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start14 Mar 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930145
- Sponsor's protocol ID
- EPIC42
- Acronym
- DIVERSO
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2023
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vega P, Murias E, Jimenez JM, Chaviano J, Rodriguez J, Calleja S, Delgado M, Benavente L, Castanon M, Puig J, Cigarran H, Arias F, Chapot R. First-line Double Stentriever Thrombectomy for M1/TICA Occlusions : Initial Experiences. Clin Neuroradiol. 2022 Dec;32(4):971-977. doi: 10.1007/s00062-022-01161-2. Epub 2022 Apr 13.
PubMed 35416489Li J, Tiberi R, Canals P, Vargas D, Castano O, Molina M, Tomasello A, Ribo M. Double stent-retriever as the first-line approach in mechanical thrombectomy: a randomized in vitro evaluation. J Neurointerv Surg. 2023 Dec;15(12):1224-1228. doi: 10.1136/jnis-2022-019887. Epub 2023 Jan 10.
PubMed 36627194Okada H, Matsuda Y, Chung J, Crowley RW, Lopes DK. Utility of a Y-configured stentriever technique as a rescue method of thrombectomy for an intractable rooted thrombus located on the middle cerebral artery bifurcation: technical note. Neurosurg Focus. 2017 Apr;42(4):E17. doi: 10.3171/2017.1.FOCUS16511.
PubMed 28366064Cabral LS, Mont'Alverne F, Silva HC, Passos Filho PE, Magalhaes PSC, Bianchin MM, Nogueira RG. Device size selection can enhance Y-stentrieving efficacy and safety as a rescue strategy in stroke thrombectomy. J Neurointerv Surg. 2022 Jun;14(6):558-563. doi: 10.1136/neurintsurg-2021-017751. Epub 2021 Jul 7.
PubMed 34233944Li Z, Liu P, Zhang L, Zhang Y, Fang Y, Xing P, Huang Q, Yang P, Liu J. Y-Stent Rescue Technique for Failed Thrombectomy in Patients With Large Vessel Occlusion: A Case Series and Pooled Analysis. Front Neurol. 2020 Aug 27;11:924. doi: 10.3389/fneur.2020.00924. eCollection 2020.
PubMed 32973671
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing the Effectiveness and Security of the Use of Two Stentrievers Simultaneously Versus One Stentriever as a Primary Treatment in Acute Ischemic Stroke Patients.
- ClinicalTrials.gov ID
- NCT05930145
- Acronym / sponsor ID
- DIVERSO / EPIC42
- Conditions
- Stroke, Thrombectomy, Arterial Occlusive Diseases
- Keywords
- Stroke, Double Stentriever, Thrombectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 5 Jul 2023 (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.
Several studies have demonstrated that simultaneous treatment with two stentrievers (STs) as rescue treatment is very effective, with high recanalization rates even in this group of patients where other revascularization techniques have failed. There has been no observed increase in hemorrhagic complications. Recently, a prospective study has been published where treatment with two ST has been shown to be effective and safe if used as a first-choice treatment (not as rescue) with a successful recanalization rate (eTICI 2c/3) after the first pass of 69%. These results have been reinforced after the publication of a randomized study that confirms, in vitro, the superiority of using two ST over one.
Detailed description
The use of a double stent retriever has been proposed as a safe and effective technique. The investigators hypothesized that the use of double stentriever primary could lead to higher first pass effect rates and better outcomes compared to single stentriever primary.
Our goal is to develop a research project to provide additional information on the potential benefits of the simultaneous double stent approach primarily in stroke patients receiving endovascular treatment.
A randomized study to compare the efficacy of double primary stentriever versus single primary stentriever.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double stentriever technique | Experimental | Device: Double stentrieverPatients treated with thrombectomy with a proximal balloon guiding catheter using two stentrievers simultaneously (one of 6 mm x 50 mm and another of 6 mm x 50 mm or 4 mm x 35 mm) |
| Single stentriever technique | Active comparator | Device: Single stentrieverPatients treated with thrombectomy with a proximal balloon guiding catheter using one stentriever (6 mm x 50 mm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A new disabling focal neurological deficit compatible with acute cerebral ischemia.
- Any age. Informed consent obtained from the patient or representative.
- NIHSS score ≥ 6.
- Pre-existing functional clinical status less than or equal to 2 according to the mRS clinical scale.
- Maximum time of 24 hours from symptom onset to arterial puncture. • TICI 0-1 in the diagnosed TICA (terminal internal carotid artery) , MCA (middle cerebral artery), and BA( basilar artery confirmed by angioCT and angiography).
Key exclusion criteria (13 listed)
- Those described in the usual protocols for mechanical thrombectomy of each hospital.
- Pre-existing functional clinical status greater than 2 according to the mRS clinical scale
- Patients with tandem lesions of dissection or arteriosclerotic origin located in the extracranial internal carotid artery.
- Initiation of treatment with a different technique than the one described.
- Inability to use a proximal balloon guide catheter.
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 |
|---|---|---|
| Double stentrieverDouble stentriever technique | Device | Double stentriever technique |
| Single stentrieverSingle stentriever technique | Device | Single stentriever technique |
Primary outcome
EFFECTIVENESS OBJECTIVE: Complete recanalization on first pass
Time frame: 90 days
Comparison of the complete recanalization rate in the first pass in the double stent group compared to the single stent group, defined as TICI greater than 2c on the Thrombolysis in Cerebral Infarction scale (eTICI scale).
SAFETY OBJECTIVE: Intracerebral hemorrhage.
Time frame: 24 hours
Rate of patients with symptomatic intracranial hemorrhage (neurological deterioration in National Institutes of Health Stroke Scale [NIHSS] >4) at 24h observed between both groups and, fundamentally, evaluated by CT.
12 secondary outcomes
Intervention success.
Time frame: During the procedure
Complications related to the intervention.
Time frame: During the procedure
Embolism in new territories.
Time frame: During the procedure
Number of passes with the devices.
Time frame: During the procedure
Procedure time.
Time frame: During the procedure
Arterial Recanalization (eTICI scale) on first pass.
Time frame: During the procedure
Arterial recanalization at the end of the procedures.
Time frame: During the procedure
Intracerebral hemorrhage.
Time frame: 24 hours
Early neurological improvement.
Time frame: 24 hours
National Institutes of Health Stroke Scale (NIHSS) scale at 24 hours, on day 5, or at discharge.
Time frame: 5 days
Modified Rankin Scale (mRS) scale at 90 days.
Time frame: 90 days
Mortality rate.
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Background: PubMed 35416489Vega P, Murias E, Jimenez JM, Chaviano J, Rodriguez J, Calleja S, Delgado M, Benavente L, Castanon M, Puig J, Cigarran H, Arias F, Chapot R. First-line Double Stentriever Thrombectomy for M1/TICA Occlusions : Initial Experiences. Clin Neuroradiol. 2022 Dec;32(4):971-977. doi: 10.1007/s00062-022-01161-2. Epub 2022 Apr 13.
- Background: PubMed 36627194Li J, Tiberi R, Canals P, Vargas D, Castano O, Molina M, Tomasello A, Ribo M. Double stent-retriever as the first-line approach in mechanical thrombectomy: a randomized in vitro evaluation. J Neurointerv Surg. 2023 Dec;15(12):1224-1228. doi: 10.1136/jnis-2022-019887. Epub 2023 Jan 10.
- Background: PubMed 28366064Okada H, Matsuda Y, Chung J, Crowley RW, Lopes DK. Utility of a Y-configured stentriever technique as a rescue method of thrombectomy for an intractable rooted thrombus located on the middle cerebral artery bifurcation: technical note. Neurosurg Focus. 2017 Apr;42(4):E17. doi: 10.3171/2017.1.FOCUS16511.
- Background: PubMed 34233944Cabral LS, Mont'Alverne F, Silva HC, Passos Filho PE, Magalhaes PSC, Bianchin MM, Nogueira RG. Device size selection can enhance Y-stentrieving efficacy and safety as a rescue strategy in stroke thrombectomy. J Neurointerv Surg. 2022 Jun;14(6):558-563. doi: 10.1136/neurintsurg-2021-017751. Epub 2021 Jul 7.
- Background: PubMed 32973671Li Z, Liu P, Zhang L, Zhang Y, Fang Y, Xing P, Huang Q, Yang P, Liu J. Y-Stent Rescue Technique for Failed Thrombectomy in Patients With Large Vessel Occlusion: A Case Series and Pooled Analysis. Front Neurol. 2020 Aug 27;11:924. doi: 10.3389/fneur.2020.00924. eCollection 2020.
- 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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double stentriever and Single stentriever in people with Stroke and Thrombectomy, run by Fundación EPIC at 4 sites in 2 countries.
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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PEDRO VEGA VALDES, MD, PhD (0034985108000 ext. 39116, peveval@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFFECTIVENESS OBJECTIVE: Complete recanalization on first pass (time frame: 90 days). The study lists 2 primary outcomes in all. 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 NCT05930145, which also lists 5 linked publications.
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 28 Jul 2025.