NCT02216643

Brief 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. 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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P25-P50 for phase_3 stroke

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2014

Completed
2.5 years until next milestone

Study Start

First participant enrolled

February 8, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

2.4 years

First QC Date

August 13, 2014

Last Update Submit

February 16, 2020

Conditions

StrokeIschemic Stroke

Keywords

StrokeIschemic StrokeThrombectomyReperfusion TherapyTreatment

Outcome Measures

Primary Outcomes (1)

  • 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

    90 days

Secondary Outcomes (10)

  • Functional independence (modified Rankin Score ≤ 2)

    90 days

  • Infarct Burden at 24 hours

    24 hours

  • Dramatic early favorable response

    24 hours

  • Cost effectiveness

    Life-time horizon perspective

  • Quality of life analysis

    3 months, 6 months, 1 year

  • +5 more secondary outcomes

Study Arms (2)

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

Procedure: ThrombectomyDevice: 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

Interventions

ThrombectomyPROCEDURE

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.

Also known as: Endovascular treatment, Intrarterial treatment, Endovascular revascularization
thrombectomy
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.

thrombectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Hospital Geral de Fortaleza/SUS

Fortaleza, Ceará, Brazil

Location

Hospital Estadual Central

Vitória, Espírito Santo, Brazil

Location

Hospital Geral Roberto Santos

Salvador, Estado de Bahia, Brazil

Location

Hospital de Base do Distrito Federal

Brasília, Federal District, Brazil

Location

Hospital de Clínicas da Universidade Federal do Paraná

Curitiba, Paraná, Brazil

Location

Hospital São José do Avaí

Itaperuna, Rio de Janeiro, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

UNIÃO BRASILEIRA DE EDUCAÇÃO E ASSISTENCIA, Hospital São Lucas PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Governador Celso Ramos

Florianópolis, Santa Catarina, Brazil

Location

Clinica Neurologica e Neurocirurgica de Joinville S/S Ltda

Joinville, Santa Catarina, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de Botucatu

Botucatu, São Paulo, Brazil

Location

Hospital de Clínicas - UNICAMP

Campinas, São Paulo, Brazil

Location

Hospital de Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Location

Irmandade da Santa Casa de Misericórdia

São Paulo, São Paulo, Brazil

Location

Universidade Federal de São Paulo - UNIFESP/EPM

São Paulo, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 38182456DERIVED

  • Martins 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.

    PMID: 32521133DERIVED

  • Gagliardi 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.

    PMID: 30758449DERIVED

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Raul Nogueira, MD

    Emory University

    PRINCIPAL INVESTIGATOR

  • Sheila CO Martins, MD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PHD, Stroke Neurologist

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 15, 2014

Study Start

February 8, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(15)