Stroke, AcuteSTRIPENCT05595876
Stent Retriever Versus Contact Aspiration in Irregular Occlusion Phenotype
A study testing stent retriever thrombectomy and contact aspiration thrombectomy in people with Stroke, Acute, run by Hopital Foch at 9 sites in France.
Trial summary
Patients with a clinico-neuroradiological mismatch pattern shown on the magnetic resonance imaging/Computed Tomography in the acute phase of stroke are more likely to benefit from reperfusion, are suitable candidates for endovascular therapy, and have a better clinical prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- stent retriever thrombectomy and contact aspiration thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 356 participants
- Where
- 9 sitesFrance
- Study dates
- 19 Dec 2022to 1 Nov 2025
- Phase
- Interventional
- 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
- Age ≥ 18 years
- M1-Middle Cerebral Artery occlusion
- Eligible for mechanical thrombectomy: groin puncture performed within 24 hours from the first symptoms or from the last time the patient was seen normal.
- Presence of a mismatch on Magnetic resonance imaging MRI or CT (computed tomography) scan
- Baseline mRS <2
- Irregular occlusion phenotype on the first angiographic run
- Informed consent obtained from the patients/his proxy or following an emergency procedure
- Being covered by a national health insurance
Who cannot join
- Isolated M2 occlusions
- Clinical history, past imaging or clinical judgment suggesting underlying intracranial stenosis
- Severe contrast medium allergy or absolute contraindication to use of iodinated products
- Patients with severe or fatal comorbidities that will likely prevent improvement or follow-up, or that will render the procedure unlikely to benefit the patient
- Angiographic evidence of carotid dissection or tandem cervical occlusion or stenosis requiring treatment
- Pregnancy (urine or serum beta HCG test for women of child-bearing potential)
- Patient benefiting from a legal protection (guardianship or curatorship)
- Being deprived of liberty
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites, 9 recruiting
- Not yet recruiting
Chu Bordeaux
Bordeaux
Gaultier MARNAT, Gaultier.marnart@chu-bordeaux.fr
- Not yet recruiting
CHU Montpellier
Montpellier
Vincent COSTALAT, vincent.costalat@chu-montpellier.fr
- Recruiting
Chru Nancy
Nancy
Benjamin GORY, b.gory@chu-nancy.fr
- Recruiting
Chu Nantes
Nantes
Romain BOURCIER, romain.bourcier@chu-nantes.fr
- Recruiting
APHP - Pitié Salpêtrière
Paris
Frédéric CLARENCON, frederic.clarencon@aphp.fr
- Recruiting
Fondation Adolphe de Rothschild
Paris
Michel PIOTIN, mpiotin@for.paris
- Recruiting
CHU de Reims
Reims
Sébastien SOIZE, ssoize@chu-reims.fr
- Recruiting
Hôpital FOCH
Suresnes
Arturo CONSOLI, 0033146251955, a.consoli@hopital-foch.com
- Recruiting
CHU de Tours
Tours
Grégoire BOULOUIS, g.boulouis@chu-tours.fr
About this study
Official title: Stent Retriever Versus Contact Aspiration in Irregular Occlusion Phenotype, a Novel Approach in the Endovascular Treatment of Acute Ischemic Stroke: the STRIPE Randomized Trial.
Patients with a clinico-neuroradiological mismatch pattern shown on the magnetic resonance imaging/Computed Tomography in the acute phase of stroke are more likely to benefit from reperfusion, are suitable candidates for endovascular therapy, and have a better clinical prognosis.
The ASTER Trial showed similar results between stent-retrievers and contact aspiration concerning the recanalization grade in anterior circulation occlusions. However, we still observe late and futile recanalizations, secondary either to extended ischemic lesions at baseline, long-time procedures or intraprocedural complications. The First Pass Effect that is the complete/nearly complete recanalization after the first maneuver, independently on the technique used, has been strongly associated with better clinical outcomes . In a recent paper we proposed a novel approach to identify those cases that could be treated with a specific technique (stent-retriever) with higher chances to achieve a complete or nearly complete recanalization, with lower procedure times and lower complication rates. This approach is focused on the identification of a regular or irregular phenotype of the occlusion site in patients with an M1-Middle Cerebral Artery occlusion. The phenotype is defined as "regular" whether the profile of the occlusion is abruptly cut without any irregularity and as "irregular" if any irregularity of the profile of the occlusion is observed. One of the hypotheses that could explain these results could be related to the composition of the clot : a soft and less organized clot could be more easily flattened by the pulsatile flow and therefore determine a regular aspect of the occlusion. A more solid and organized clot would, on the contrary, maintain an irregular profile because it would not be flattened by the blood flow and the contrast medium could highlight the irregularities of the proximal face of the clot.
The latter could be a favorable target for the use of a stent-retriever since the interaction between a solid clot and the struts of the stent could increase the chance to retrieve the clot. Therefore, we propose this randomized controlled trial to assess the superiority of stent-retrievers compared to contact aspiration in the treatment of irregular phenotype occlusions of the M1-Middle Cerebral Artery.
Read the detailed description
Statistical analyses will be independently performed by the Biostatistics Department of University of Lille under the responsibility of Julien Labreuche. Data will be analyzed using the SAS software (SAS Institute Inc, Cary, NC, USA). A detailed statistical analysis plan will be written and finalized prior to the database lock. Baseline characteristics will be described for each group. Quantitative variables will be expressed as mean (standard deviation) or median (interquartile range) for non-Gaussian distribution. Qualitative variables will be expressed as frequencies and percentages. Normality of distribution will be assessed graphically and using the Shapiro-Wilk test. All applicable statistical tests will be 2-sided and no correction for multiple comparisons will be applied; all secondary objectives will be considered as exploratory and results were reported with only effect size estimates with their confidence intervals (CIs). All CIs presented will be 95%CI and 2-sided. The final report will be written, based on the CONSORT statement recommendations.
- Conditions
- Stroke, Acute
- Being tested
- stent retriever thrombectomy, contact aspiration thrombectomy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stent retriever thrombectomyProcedure or surgery
The technique used should be in accordance with the device IFU (instructions for use). A large bore access guide catheter possible is mandatory. A suitable delivery microcatheter is navigated over a microwire across the occlusion. A control superselective angiogram may be used to document the extent of occlusion and thrombus. The stent is left in place according to the internal practice of each participating center before the withdrawal. Any CE (european compliance)-marked stent retriever device is then deployed across the occlusion. A contact aspiration large bore catheter can be used in association with the stent retriever. A minimum of 3 attempts with Stent retriever should be performed. A revascularization score will be recorded after each device attempt.
contact aspiration thrombectomyProcedure or surgery
A 0.021 to 0.027 inch inner lumen microcatheter with a 0.014 to 0.016 inch microwire inside is then introduced into a large-bore aspiration catheter and this construct is introduced into the long sheath as a unit. A large bore balloon guide catheter has to be placed into the cervical internal carotid artery. The microcatheter is then advanced close to the thrombus and the large-bore aspiration catheter is advanced as close to the proximal aspect of the thrombus as possible. A control angiogram may be used to document the extent of occlusion and thrombus. After a 3 min waiting period, the large-bore aspiration catheter is connected to a continuous aspiration from the dedicated aspiration pump while simultaneously advancing the aspiration catheter up to the face of the thrombus. Once thrombus will be close to the aspiration catheter, then the system will carefully removed as a unit under continuous aspiration.
| Study group | Role | What they receive |
|---|---|---|
| Stent retriever | Experimental | The patients will be treated to receive stent retriever (with or without contact aspiration) first line thrombectomy (experimental arm). Receives: Procedure: stent retriever thrombectomy |
| Contact aspiration | Sham comparator | The patients will be treated to receive direct contact aspiration first line thrombectomy (control arm) Receives: Procedure: contact aspiration thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of favorable functional outcome at 90-day defined by a Modified Rankin Scale (mRS) 0-2
mRS is evaluated between 0 to 6. A score of 0 indicates that there is no disability and a score of 6 indicates death
Measured: 3 months
Secondary outcomes (10)
Rate of patients with first pass effect (FPE) defined as mTICI 2c/3 after first device maneuver
The definition of FPE: single pass/use of the device, (2) complete revascularization of the large vessel occlusion and its downstream territory (mTICI 3), and (3) no use of rescue therapy
Measured: 24 hours
Rates of patients with complete (mTICI 3), perfect (mTICI 2c/3) and successful reperfusion (mTICI 2b/3) at the end of endovascular procedure
mTICI (modified Thrombolysis In Cerebral Infarction ) score equals to 3 after the first line thrombectomy and at the end of endovascular.
mTICI score is evaluated between 0-3 : 0 a complete obstruction of the artery and 3 indicates a complete reperfusion
Measured: 24 hours
Time from groin puncture to achieve the maximum recanalization
The time between the groin puncture and the maxiamum recanalization will be assessed
Measured: 24 hours
Rate of patients who will require less than 2 device pass
Rate of patients who require less than 2 devices pass
Measured: 24 hours
Rate of patients with rescue therapy use
Rate of patient with other than one pass with thrombectomy device
Measured: 24 hours
Degree of disability assessed by overall distribution of the mRS at 90 days and one year (shift analysis combining scores of 5 and 6)
overall distribution of the mRS at 90 days and one year
Measured: 12 months
Rate of all-cause mortality at 90 day and one year
number of mortality at 90 days and on year
Measured: 12 months
24 hours change in NIHSS from baseline defined as the difference between NIHSS score at 24 hours and NIHSS score at admission
NIHSS (National Institutes of Health Stroke Scale) score is evaluated between 0-42 0 is normal and 42 maximal gravity
Measured: 24 hours
Incidence of intracerebral haemorrhage (ICH), parenchymal hematoma, symptomatic ICH, on brain imaging (Magnetic resonance imaging MRI or CT (computed tomography) scan) at 24 hours after thrombectomy (according to ECASS3 classification)
ECASS III (European Cooperative Acute Stroke Study) classification :
- Hemorrhage infarction type 1 (HI1)
- Hemorrhage infarction type 2 (HI2)
- Parenchymal hematoma type 1 (PH1)
- Parenchymal hematoma type 2 (PH2)
Measured: 24 hours
Incidence of procedure-related complications such as arterial perforation or dissection, embolization in new territory
arterial perforation or dissection, embolization in new territory
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start19 Dec 2022
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arturo CONSOLI, Principal investigator, Foch HospitalBertrand LAPERGUE, Study chair, Foch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595876
- Sponsor's protocol ID
- 2019_0017
- Acronym
- STRIPE
- Status last verified
- Feb 2024
- First submitted
- 24 Oct 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stent Retriever Versus Contact Aspiration in Irregular Occlusion Phenotype, a Novel Approach in the Endovascular Treatment of Acute Ischemic Stroke: the STRIPE Randomized Trial.
- ClinicalTrials.gov ID
- NCT05595876
- Acronym / sponsor ID
- STRIPE / 2019_0017
- Conditions
- Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 27 Oct 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.
Patients with a clinico-neuroradiological mismatch pattern shown on the magnetic resonance imaging/Computed Tomography in the acute phase of stroke are more likely to benefit from reperfusion, are suitable candidates for endovascular therapy, and have a better clinical prognosis.
The ASTER Trial showed similar results between stent-retrievers and contact aspiration concerning the recanalization grade in anterior circulation occlusions. However, we still observe late and futile recanalizations, secondary either to extended ischemic lesions at baseline, long-time procedures or intraprocedural complications. The First Pass Effect that is the complete/nearly complete recanalization after the first maneuver, independently on the technique used, has been strongly associated with better clinical outcomes . In a recent paper we proposed a novel approach to identify those cases that could be treated with a specific technique (stent-retriever) with higher chances to achieve a complete or nearly complete recanalization, with lower procedure times and lower complication rates. This approach is focused on the identification of a regular or irregular phenotype of the occlusion site in patients with an M1-Middle Cerebral Artery occlusion. The phenotype is defined as "regular" whether the profile of the occlusion is abruptly cut without any irregularity and as "irregular" if any irregularity of the profile of the occlusion is observed. One of the hypotheses that could explain these results could be related to the composition of the clot : a soft and less organized clot could be more easily flattened by the pulsatile flow and therefore determine a regular aspect of the occlusion. A more solid and organized clot would, on the contrary, maintain an irregular profile because it would not be flattened by the blood flow and the contrast medium could highlight the irregularities of the proximal face of the clot.
The latter could be a favorable target for the use of a stent-retriever since the interaction between a solid clot and the struts of the stent could increase the chance to retrieve the clot. Therefore, we propose this randomized controlled trial to assess the superiority of stent-retrievers compared to contact aspiration in the treatment of irregular phenotype occlusions of the M1-Middle Cerebral Artery.
Detailed description
Statistical analyses will be independently performed by the Biostatistics Department of University of Lille under the responsibility of Julien Labreuche. Data will be analyzed using the SAS software (SAS Institute Inc, Cary, NC, USA). A detailed statistical analysis plan will be written and finalized prior to the database lock. Baseline characteristics will be described for each group. Quantitative variables will be expressed as mean (standard deviation) or median (interquartile range) for non-Gaussian distribution. Qualitative variables will be expressed as frequencies and percentages. Normality of distribution will be assessed graphically and using the Shapiro-Wilk test. All applicable statistical tests will be 2-sided and no correction for multiple comparisons will be applied; all secondary objectives will be considered as exploratory and results were reported with only effect size estimates with their confidence intervals (CIs). All CIs presented will be 95%CI and 2-sided. The final report will be written, based on the CONSORT statement recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent retriever | Experimental | Procedure: stent retriever thrombectomyThe patients will be treated to receive stent retriever (with or without contact aspiration) first line thrombectomy (experimental arm). |
| Contact aspiration | Sham comparator | Procedure: contact aspiration thrombectomyThe patients will be treated to receive direct contact aspiration first line thrombectomy (control arm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- M1-Middle Cerebral Artery occlusion
- Eligible for mechanical thrombectomy: groin puncture performed within 24 hours from the first symptoms or from the last time the patient was seen normal.
- Presence of a mismatch on Magnetic resonance imaging MRI or CT (computed tomography) scan
- Baseline mRS <2
Key exclusion criteria (8 listed)
- Isolated M2 occlusions
- Clinical history, past imaging or clinical judgment suggesting underlying intracranial stenosis
- Severe contrast medium allergy or absolute contraindication to use of iodinated products
- Patients with severe or fatal comorbidities that will likely prevent improvement or follow-up, or that will render the procedure unlikely to benefit the patient
- Angiographic evidence of carotid dissection or tandem cervical occlusion or stenosis requiring treatment
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 |
|---|---|---|
| stent retriever thrombectomyThe technique used should be in accordance with the device IFU (instructions for use). A large bore access guide catheter possible is mandatory. A suitable delivery microcatheter is navigated over a microwire across the occlusion. A control superselective angiogram may be used to document the extent of occlusion and thrombus. The stent is left in place according to the internal practice of each participating center before the withdrawal. Any CE (european compliance)-marked stent retriever device is then deployed across the occlusion. A contact aspiration large bore catheter can be used in association with the stent retriever. A minimum of 3 attempts with Stent retriever should be performed. A revascularization score will be recorded after each device attempt. | Procedure or surgery | Stent retriever |
| contact aspiration thrombectomyA 0.021 to 0.027 inch inner lumen microcatheter with a 0.014 to 0.016 inch microwire inside is then introduced into a large-bore aspiration catheter and this construct is introduced into the long sheath as a unit. A large bore balloon guide catheter has to be placed into the cervical internal carotid artery. The microcatheter is then advanced close to the thrombus and the large-bore aspiration catheter is advanced as close to the proximal aspect of the thrombus as possible. A control angiogram may be used to document the extent of occlusion and thrombus. After a 3 min waiting period, the large-bore aspiration catheter is connected to a continuous aspiration from the dedicated aspiration pump while simultaneously advancing the aspiration catheter up to the face of the thrombus. Once thrombus will be close to the aspiration catheter, then the system will carefully removed as a unit under continuous aspiration. | Procedure or surgery | Contact aspiration |
Primary outcome
Rate of favorable functional outcome at 90-day defined by a Modified Rankin Scale (mRS) 0-2
Time frame: 3 months
mRS is evaluated between 0 to 6. A score of 0 indicates that there is no disability and a score of 6 indicates death
10 secondary outcomes
Rate of patients with first pass effect (FPE) defined as mTICI 2c/3 after first device maneuver
Time frame: 24 hours
Rates of patients with complete (mTICI 3), perfect (mTICI 2c/3) and successful reperfusion (mTICI 2b/3) at the end of endovascular procedure
Time frame: 24 hours
Time from groin puncture to achieve the maximum recanalization
Time frame: 24 hours
Rate of patients who will require less than 2 device pass
Time frame: 24 hours
Rate of patients with rescue therapy use
Time frame: 24 hours
Degree of disability assessed by overall distribution of the mRS at 90 days and one year (shift analysis combining scores of 5 and 6)
Time frame: 12 months
Rate of all-cause mortality at 90 day and one year
Time frame: 12 months
24 hours change in NIHSS from baseline defined as the difference between NIHSS score at 24 hours and NIHSS score at admission
Time frame: 24 hours
Incidence of intracerebral haemorrhage (ICH), parenchymal hematoma, symptomatic ICH, on brain imaging (Magnetic resonance imaging MRI or CT (computed tomography) scan) at 24 hours after thrombectomy (according to ECASS3 classification)
Time frame: 24 hours
Incidence of procedure-related complications such as arterial perforation or dissection, embolization in new territory
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- 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.
Arturo CONSOLI principal investigator
Foch Hospital
Bertrand LAPERGUE study chair
Foch Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stent retriever thrombectomy and contact aspiration thrombectomy in people with Stroke, Acute, run by Hopital Foch at 9 sites 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marthe MAHI (0033146257387, m.mahi@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of favorable functional outcome at 90-day defined by a Modified Rankin Scale (mRS) 0-2 (time frame: 3 months). 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 29 Feb 2024.