StrokePhase 3RESILIENTNCT02216643
EndoVascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke
A Phase 3 study testing Thrombectomy and Stentriever Solitaire FR® or Penumbra System® in people with Stroke and Ischemic Stroke, run by Hospital de Clinicas de Porto Alegre at 15 sites in Brazil.
Trial summary
Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with stentriever and/or Thromboaspiration versus medical management alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic Stroke
- What is being tested?
- Thrombectomy and Stentriever Solitaire FR® or Penumbra System®
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 15 sitesBrazil
- Study dates
- 8 Feb 2017to 30 Jun 2019
- Phase
- Phase 3
- 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
- Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., subject presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without clinical improvement.
- No significant pre-stroke functional disability (mRS ≤ 1)
- Baseline NIHSS score obtained prior to randomization must be equal or higher than 8 points
- Age ≥18 years
- Occlusion (TICI 0-1) of the intracranial ICA (distal ICA or T occlusions) and/or MCA-M1 segment suitable for endovascular treatment, as evidenced by CTA, MRA or angiogram, with or without concomitant cervical carotid occlusion or stenosis.
- Patient treatable within eight hours of symptom onset. Symptoms onset is defined as point in time the patient was last seen well (at baseline). Treatment start is defined as groin puncture.
- Informed consent obtained from patient or acceptable patient surrogate
Who cannot join
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
- Baseline platelet count < 30.000/µL
- Baseline blood glucose of < 50mg/dL or > 400mg/dl
- Severe, sustained hypertension (SBP > 185 mm Hg or DBP > 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using AHA guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled.
- Patients in coma (NIHSS item of consciousness >1) (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation).
- Seizures at stroke onset which would preclude obtaining a baseline NIHSS
Show all 21Show fewer
- Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
- History of life threatening allergy (more than rash) to contrast medium
- Subjects who has received IV t-PA treatment beyond 4,5 hours from the beginning of the symptoms
- Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission.
- Subject participating in a study involving an investigational drug or device that would impact this study.
- Cerebral vasculitis
- Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤1. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)
- Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas).
- Hypodensity on CT or restricted diffusion amounting to an ASPECTS score of <6 on NCCT, or <5 on DWI MRI. The use of CTP or MRI perfusion is optional.
- Collaterals with malignant profile on CTA (without colateral circulation on CTA)
- CT or MR evidence of hemorrhage (the presence of GRE microbleeds is allowed).
- Significant mass effect with midline shift.
- Evidence of ipsilateral carotid occlusion, high grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery that cannot be treated or will prevent access to the intracranial clot or excessive tortuosity of cervical vessels precluding device delivery/deployment
- Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
- Evidence of intracranial tumor (except small meningioma).
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Brazil15 sites
Hospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu, São Paulo
Hospital de Base do Distrito Federal
Brasília, Federal District
Hospital de Clínicas - UNICAMP
Campinas, São Paulo
Hospital de Clínicas da Universidade Federal do Paraná
Curitiba, Paraná
Hospital Governador Celso Ramos
Florianópolis, Santa Catarina
Hospital Geral de Fortaleza/SUS
Fortaleza, Ceará
Hospital São José do Avaí
Itaperuna, Rio de Janeiro
Clinica Neurologica e Neurocirurgica de Joinville S/S Ltda
Joinville, Santa Catarina
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
UNIÃO BRASILEIRA DE EDUCAÇÃO E ASSISTENCIA, Hospital São Lucas PUCRS
Porto Alegre, Rio Grande do Sul
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo
Hospital Geral Roberto Santos
Salvador, Estado de Bahia
Irmandade da Santa Casa de Misericórdia
São Paulo, São Paulo
Universidade Federal de São Paulo - UNIFESP/EPM
São Paulo
Hospital Estadual Central
Vitória, Espírito Santo
About this study
Official title: Randomization of Endovascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke Due to Large VEssel OcclusioN Trial
Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with stentriever and/or Thromboaspiration versus medical management alone. Randomization will be done under a minimization process using age, baseline NIHSS, use of IV tpa, vessel occlusion site and hospital. To evaluate the hypothesis that mechanical thrombectomy is superior to medical management alone in achieving more favorable outcomes in the distribution of the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel ischemic stroke <8 hours from symptom onset. Subjects are either ineligible for IV alteplase or have received IV alteplase therapy without recanalization. Sample size is projected to be 690 patients for a difference in treatment effect of 10%.
Read the detailed description
Patients with acute ischemic stroke related to anterior circulation large vessel occlusion will be randomized up to 8 hours from symptoms onset in both arms (mechanical thrombectomy versus medical management alone). Subjects are either ineligible for IV alteplase or have received IV alteplase therapy without recanalization. They will be admitted at acute stroke units in Brazil (or ICU if needed) and treated following international guidelines. Concomitant medications and non-pharmacological therapies will be recorded. A maximum of six attempts to retrieve the thrombus in a single vessel can be made. No additional treatment will be allowed either with Intrarterial tPA, mechanical devices or angioplasty/stenting.
The primary endpoint will be distribution of the modified Rankin Scale scores at 90 days (shift analysis) as evaluated by two separate assessors who are blinded to treatment
Interim Analysis The sample size for this Phase III Trial is projected to be 690 subjects. For interim analyses, the method of Lan and DeMets will be used to allocate alpha via the power family method with φ (phi) equal to 1 for the assessment of efficacy and futility, respectively after the first 174, 346 and 518 patients enrolled have completed the 90-day follow-up. The interval may be more frequent if requested by the Data and Safety Monitoring Board (DSMB). At interim analysis, in case the stopping boundaries are crossed the DSMB may recommend stopping the study either for better efficacy of the tested treatment either for futility. Other factors, such as safety, will be taken into consideration by the DSMB in the decision to stop the study. When considering stopping the trial for safety reasons, the DSMB will be instructed to consider both mortality (mRS=6) and severe dependency (mRS=5) at 3 months as one single outcome.
- Conditions
- Stroke, Ischemic Stroke
- Being tested
- Thrombectomy, Stentriever Solitaire FR® or Penumbra System®
- Keywords
- Stroke, Ischemic Stroke, Thrombectomy, Reperfusion Therapy, Treatment
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThrombectomyProcedure or surgery
Also called Endovascular treatment, Intrarterial treatment, Endovascular revascularization
Patients with acute ischemic stroke with anterior circulation large vessel occlusion will be randomized to receive mechanical thrombectomy with stent-retriever Solitaire FR® and/or thromboaspiration with Penumbra System® versus medical management alone versus medical management alone. A maximum of six attempts to retrieve the thrombus in a single vessel can be made . No additional treatment will be allowed either with IA tPA, other mechanical devices or angioplasty/stenting.
Stentriever Solitaire FR® or Penumbra System®Device
Patients with acute ischemic stroke with anterior circulation large vessel occlusion will be randomized to receive mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone versus medical management alone. A maximum of six attempts to retrieve the thrombus in a single vessel can be made . No additional treatment will be allowed either with IA tPA, other mechanical devices or angioplasty/stenting.
| Study group | Role | What they receive |
|---|---|---|
| thrombectomy | Experimental | mechanical thrombectomy with stentriever Solitaire FR® and/or thromboaspiration with Penumbra System® in patients with large vessel occlusion in cerebral anterior circulation vessels Receives: Procedure: Thrombectomy; Device: Stentriever Solitaire FR® or Penumbra System® |
| best medical treatment | No intervention | best medical treatment in patients with acute ischemic stroke with anterior circulation large vessel occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of the modified Rankin Scale scores (shift analysis)
Distribution of the modified Rankin Scale scores at 90 days (shift analysis) as evaluated by two separate assessors who are blinded to treatment
Measured: 90 days
Secondary outcomes (10)
Functional independence (modified Rankin Score ≤ 2)
Functional independence measured by modified Rankin Score ≤ 2 in 90 days in both groups
Measured: 90 days
Infarct Burden at 24 hours
ASPECTS change from baseline to 24 hours on CT or MRI
Measured: 24 hours
Dramatic early favorable response
defined as an NIHSS score 0-2 or a NIHSS score decrease of ≥8 from baseline at 24 hours
Measured: 24 hours
Cost effectiveness
Cost effectiveness analysis of interventional therapy vs medical therapy alone
Measured: Life-time horizon perspective
Quality of life analysis
Quality of life analysis as measured by EuroQol/EQ5D at 3 month, 6 months and one year, between interventional therapy vs medical therapy alone
Measured: 3 months, 6 months, 1 year
Vessel recanalization at 24 hours
Vessel recanalization evaluated by CT angiography (CTA) or MR angiography (MRA) at 24 hours in both treatment groups
Measured: 24 hours
Successful recanalization at the end of procedure
defined as a grade of 2b or 3 (indicating reperfusion of >50% of the affected territory) on the modified Thrombolysis in Cerebral Infarction (mTICI) scale
Measured: immediatelly after procedure (only thrombectomy arm)
Mortality
Mortality at 90 days
Measured: 90 days
Symptomatic Intracranial hemorrhage
Clinically significant Intracranial hemorrhage (ICH) rates at 24 (-2/+12) hours. All intracerebral hemorrhages will be classified by a central core-lab using the ECASS criteria for CT evaluation. Symptomatic ICH will be defined as per the SITS-MOST definition: deterioration in NIHSS score of ≥4 points within 24 hours from treatment and evidence of intraparenchymal hemorrhage type 2 in the 22 to 36 hours follow-up imaging scans. The incidence of any asymptomatic hemorrhage measured at 24 (-2/+12) hours will also be compared
Measured: 24 hours
Procedure related complications
Complications occurring during the procedure will be evaluated: distal embolization in a new territory, arterial dissection, arterial perfuration, groin hematoma
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study start8 Feb 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil, Medtronic, Penumbra Inc., iSchemaView, Inc, Brainomix Limited
- Responsible party
- Principal investigator, SHEILA CRISTINA OURIQUES MARTINS, Hospital de Clinicas de Porto Alegre
- Investigators
- Raul Nogueira, MD, Principal investigator, Emory UniversitySheila CO Martins, MD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216643
- Sponsor's protocol ID
- 22042613.6.1001.5327
- Acronym
- RESILIENT
- Status last verified
- Feb 2020
- First submitted
- 13 Aug 2014
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silva GS, Alves MM, Barros FCD, Frudit ME, Pontes-Neto OM, Mont'Alverne FJ, Rebello LC, Carbonera LA, Abud DG, Lima F, de Souza AC, Liebeskind D, Mosmann G, Bezerra D, Saver J, Cardoso F, Nogueira RG, Martins SO. The role of intravenous thrombolysis before mechanical Thrombectomy: A subgroup analysis of the RESILIENT trial. J Neurol Sci. 2024 Feb 15;457:122853. doi: 10.1016/j.jns.2023.122853. Epub 2023 Dec 20.
PubMed 38182456Martins SO, Mont'Alverne F, Rebello LC, Abud DG, Silva GS, Lima FO, Parente BSM, Nakiri GS, Faria MB, Frudit ME, de Carvalho JJF, Waihrich E, Fiorot JA Jr, Cardoso FB, Hidalgo RCT, Zetola VF, Carvalho FM, de Souza AC, Dias FA, Bandeira D, Miranda Alves M, Wagner MB, Carbonera LA, Oliveira-Filho J, Bezerra DC, Liebeskind DS, Broderick J, Molina CA, Fogolin Passos JE, Saver JL, Pontes-Neto OM, Nogueira RG; RESILIENT Investigators. Thrombectomy for Stroke in the Public Health Care System of Brazil. N Engl J Med. 2020 Jun 11;382(24):2316-2326. doi: 10.1056/NEJMoa2000120.
PubMed 32521133Gagliardi VDB, Gagliardi RJ. Current and future conditions of stroke care in Brazil. Arq Neuropsiquiatr. 2019 Jan;77(1):68-69. doi: 10.1590/0004-282X20180160. No abstract available.
PubMed 30758449
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomization of Endovascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke Due to Large VEssel OcclusioN Trial
- ClinicalTrials.gov ID
- NCT02216643
- Acronym / sponsor ID
- RESILIENT / 22042613.6.1001.5327
- Conditions
- Stroke, Ischemic Stroke
- Keywords
- Stroke, Ischemic Stroke, Thrombectomy, Reperfusion Therapy, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil, Medtronic, Penumbra Inc., iSchemaView, Inc, Brainomix Limited
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 15 Aug 2014 (estimated)
- 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.
Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with stentriever and/or Thromboaspiration versus medical management alone. Randomization will be done under a minimization process using age, baseline NIHSS, use of IV tpa, vessel occlusion site and hospital. To evaluate the hypothesis that mechanical thrombectomy is superior to medical management alone in achieving more favorable outcomes in the distribution of the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel ischemic stroke <8 hours from symptom onset. Subjects are either ineligible for IV alteplase or have received IV alteplase therapy without recanalization. Sample size is projected to be 690 patients for a difference in treatment effect of 10%.
Detailed description
Patients with acute ischemic stroke related to anterior circulation large vessel occlusion will be randomized up to 8 hours from symptoms onset in both arms (mechanical thrombectomy versus medical management alone). Subjects are either ineligible for IV alteplase or have received IV alteplase therapy without recanalization. They will be admitted at acute stroke units in Brazil (or ICU if needed) and treated following international guidelines. Concomitant medications and non-pharmacological therapies will be recorded. A maximum of six attempts to retrieve the thrombus in a single vessel can be made. No additional treatment will be allowed either with Intrarterial tPA, mechanical devices or angioplasty/stenting.
The primary endpoint will be distribution of the modified Rankin Scale scores at 90 days (shift analysis) as evaluated by two separate assessors who are blinded to treatment
Interim Analysis The sample size for this Phase III Trial is projected to be 690 subjects. For interim analyses, the method of Lan and DeMets will be used to allocate alpha via the power family method with φ (phi) equal to 1 for the assessment of efficacy and futility, respectively after the first 174, 346 and 518 patients enrolled have completed the 90-day follow-up. The interval may be more frequent if requested by the Data and Safety Monitoring Board (DSMB). At interim analysis, in case the stopping boundaries are crossed the DSMB may recommend stopping the study either for better efficacy of the tested treatment either for futility. Other factors, such as safety, will be taken into consideration by the DSMB in the decision to stop the study. When considering stopping the trial for safety reasons, the DSMB will be instructed to consider both mortality (mRS=6) and severe dependency (mRS=5) at 3 months as one single outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thrombectomy | Experimental | Procedure: Thrombectomy, Device: Stentriever Solitaire FR® or Penumbra System®mechanical thrombectomy with stentriever Solitaire FR® and/or thromboaspiration with Penumbra System® in patients with large vessel occlusion in cerebral anterior circulation vessels |
| best medical treatment | No intervention | –best medical treatment in patients with acute ischemic stroke with anterior circulation large vessel occlusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., subject presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without clinical improvement.
- No significant pre-stroke functional disability (mRS ≤ 1)
- Baseline NIHSS score obtained prior to randomization must be equal or higher than 8 points
- Age ≥18 years
- Occlusion (TICI 0-1) of the intracranial ICA (distal ICA or T occlusions) and/or MCA-M1 segment suitable for endovascular treatment, as evidenced by CTA, MRA or angiogram, with or without concomitant cervical carotid occlusion or stenosis.
Key exclusion criteria (21 listed)
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
- Baseline platelet count < 30.000/µL
- Baseline blood glucose of < 50mg/dL or > 400mg/dl
- Severe, sustained hypertension (SBP > 185 mm Hg or DBP > 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using AHA guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled.
- Patients in coma (NIHSS item of consciousness >1) (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation).
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 |
|---|---|---|
| ThrombectomyAlso: Endovascular treatment, Intrarterial treatment, Endovascular revascularizationPatients with acute ischemic stroke with anterior circulation large vessel occlusion will be randomized to receive mechanical thrombectomy with stent-retriever Solitaire FR® and/or thromboaspiration with Penumbra System® versus medical management alone versus medical management alone. A maximum of six attempts to retrieve the thrombus in a single vessel can be made . No additional treatment will be allowed either with IA tPA, other mechanical devices or angioplasty/stenting. | Procedure or surgery | thrombectomy |
| Stentriever Solitaire FR® or Penumbra System®Patients with acute ischemic stroke with anterior circulation large vessel occlusion will be randomized to receive mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone versus medical management alone. A maximum of six attempts to retrieve the thrombus in a single vessel can be made . No additional treatment will be allowed either with IA tPA, other mechanical devices or angioplasty/stenting. | Device | thrombectomy |
Primary outcome
Distribution of the modified Rankin Scale scores (shift analysis)
Time frame: 90 days
Distribution of the modified Rankin Scale scores at 90 days (shift analysis) as evaluated by two separate assessors who are blinded to treatment
10 secondary outcomes
Functional independence (modified Rankin Score ≤ 2)
Time frame: 90 days
Infarct Burden at 24 hours
Time frame: 24 hours
Dramatic early favorable response
Time frame: 24 hours
Cost effectiveness
Time frame: Life-time horizon perspective
Quality of life analysis
Time frame: 3 months, 6 months, 1 year
Vessel recanalization at 24 hours
Time frame: 24 hours
Successful recanalization at the end of procedure
Time frame: immediatelly after procedure (only thrombectomy arm)
Mortality
Time frame: 90 days
Symptomatic Intracranial hemorrhage
Time frame: 24 hours
Procedure related complications
Time frame: During the procedure
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 19 Feb 2020.
- Derived from this study: PubMed 38182456Silva GS, Alves MM, Barros FCD, Frudit ME, Pontes-Neto OM, Mont'Alverne FJ, Rebello LC, Carbonera LA, Abud DG, Lima F, de Souza AC, Liebeskind D, Mosmann G, Bezerra D, Saver J, Cardoso F, Nogueira RG, Martins SO. The role of intravenous thrombolysis before mechanical Thrombectomy: A subgroup analysis of the RESILIENT trial. J Neurol Sci. 2024 Feb 15;457:122853. doi: 10.1016/j.jns.2023.122853. Epub 2023 Dec 20.
- Derived from this study: PubMed 32521133Martins SO, Mont'Alverne F, Rebello LC, Abud DG, Silva GS, Lima FO, Parente BSM, Nakiri GS, Faria MB, Frudit ME, de Carvalho JJF, Waihrich E, Fiorot JA Jr, Cardoso FB, Hidalgo RCT, Zetola VF, Carvalho FM, de Souza AC, Dias FA, Bandeira D, Miranda Alves M, Wagner MB, Carbonera LA, Oliveira-Filho J, Bezerra DC, Liebeskind DS, Broderick J, Molina CA, Fogolin Passos JE, Saver JL, Pontes-Neto OM, Nogueira RG; RESILIENT Investigators. Thrombectomy for Stroke in the Public Health Care System of Brazil. N Engl J Med. 2020 Jun 11;382(24):2316-2326. doi: 10.1056/NEJMoa2000120.
- Derived from this study: PubMed 30758449Gagliardi VDB, Gagliardi RJ. Current and future conditions of stroke care in Brazil. Arq Neuropsiquiatr. 2019 Jan;77(1):68-69. doi: 10.1590/0004-282X20180160. No abstract available.
- 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.
Raul Nogueira, MD principal investigator
Emory University
Sheila CO Martins, MD principal investigator
Hospital de Clinicas de Porto Alegre
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thrombectomy and Stentriever Solitaire FR® or Penumbra System® in people with Stroke and Ischemic Stroke, run by Hospital de Clinicas de Porto Alegre at 15 sites in Brazil.
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 21 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 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Distribution of the modified Rankin Scale scores (shift analysis) (time frame: 90 days). 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 NCT02216643, which also lists 3 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 19 Feb 2020.