Acute Ischemic StrokeDOBLE UPNCT07113184
Randomized a Clinical Trial With Medical Device in Acute Ischemic Stroke
A study testing dual sr and single sr in people with Acute Ischemic Stroke, run by Instituto de Investigación Marqués de Valdecilla at 3 sites in Spain.
Trial summary
This study seeks to provide high-quality evidence on the potential benefits of the dual stentriever approach, potentially informing future clinical guidelines and improving outcomes in patients with anterior circulation large vessel occlusion strokes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- dual sr and single sr
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Oct 2025to 31 Dec 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
- Age ≥ 18
- NIHSS ≥ 6
- mRS ≤ 1
- Proximal anterior circulation occlusion
- ASPECTS > 6
- Informed consent
Who cannot join
- Absence of occlusion
- Posterior circulation stroke
- Carotid dissection or tandem stenosis requiring treatment
- Severe comorbidities or contraindications to imaging contrast
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites
Hospital de Burgos
Burgos
Complejo Hospitalario de Salamanca
Salamanca
Hospital universitario marques de valdecilla
Santander
About this study
Official title: DUAL VERSUS SINGLE STENTRIEVER FOR RECANALIZATION IN ACUTE ISCHEMIC STROKE: THE RANDOMIZED DOUBLE UP TRIAL
This study seeks to provide high-quality evidence on the potential benefits of the dual stentriever approach, potentially informing future clinical guidelines and improving outcomes in patients with anterior circulation large vessel occlusion strokes.
- Conditions
- Acute Ischemic Stroke
- Being tested
- dual sr, single sr
- Keywords
- Acute ischemic stroke, mechanical thrombectomy, dual stentriever, mTICI, first pass effect, randomized trial
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual srDevice
Also called experimental
Dual Stentriever
single srDevice
Also called control
Single Stentriever
| Study group | Role | What they receive |
|---|---|---|
| Dual Stentriever | Experimental | Endovascular mechanical thrombectomy with dual or stentriever technique using a balloon guiding catheter. Receives: Device: dual sr |
| Single Stentriever | Active comparator | Endovascular mechanical thrombectomy with single stentriever technique using a balloon guiding catheter. Receives: Device: single sr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time takes in achieving complete reperfusion after a single thrombectomy pass.
To evaluate the superiority of the dual stentriever technique in achieving complete reperfusion after a single thrombectomy pass.
Measured: 24 hours or 48 hours after thrombectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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
- Model description
- Endovascular mechanical thrombectomy with either dual or single stentriever technique using a balloon guiding catheter.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113184
- Sponsor's protocol ID
- DOBLE UP
- Acronym
- DOBLE UP
- Status last verified
- Aug 2025
- First submitted
- 11 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DUAL VERSUS SINGLE STENTRIEVER FOR RECANALIZATION IN ACUTE ISCHEMIC STROKE: THE RANDOMIZED DOUBLE UP TRIAL
- ClinicalTrials.gov ID
- NCT07113184
- Acronym / sponsor ID
- DOBLE UP / DOBLE UP
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, mechanical thrombectomy, dual stentriever, mTICI, first pass effect, randomized trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Aug 2025 (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.
This study seeks to provide high-quality evidence on the potential benefits of the dual stentriever approach, potentially informing future clinical guidelines and improving outcomes in patients with anterior circulation large vessel occlusion strokes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Endovascular mechanical thrombectomy with either dual or single stentriever technique using a balloon guiding catheter.
| Arm | Type | Receives |
|---|---|---|
| Dual Stentriever | Experimental | Device: dual srEndovascular mechanical thrombectomy with dual or stentriever technique using a balloon guiding catheter. |
| Single Stentriever | Active comparator | Device: single srEndovascular mechanical thrombectomy with single stentriever technique using a balloon guiding catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18
- NIHSS ≥ 6
- mRS ≤ 1
- Proximal anterior circulation occlusion
- ASPECTS > 6
Key exclusion criteria (4 listed)
- Absence of occlusion
- Posterior circulation stroke
- Carotid dissection or tandem stenosis requiring treatment
- Severe comorbidities or contraindications to imaging contrast
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 |
|---|---|---|
| dual srAlso: experimentalDual Stentriever | Device | Dual Stentriever |
| single srAlso: controlSingle Stentriever | Device | Single Stentriever |
Primary outcome
Time takes in achieving complete reperfusion after a single thrombectomy pass.
Time frame: 24 hours or 48 hours after thrombectomy
To evaluate the superiority of the dual stentriever technique in achieving complete reperfusion after a single thrombectomy pass.
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 8 Aug 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual sr and single sr in people with Acute Ischemic Stroke, run by Instituto de Investigación Marqués de Valdecilla at 3 sites in Spain.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
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?
Time takes in achieving complete reperfusion after a single thrombectomy pass. (time frame: 24 hours or 48 hours after thrombectomy). 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 8 Aug 2025.