EndoVascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02216643
• Date of registration: 13/08/2014
• Prospective Registration: Yes
• Primary sponsor: Hospital de Clinicas de Porto Alegre
• Public title: EndoVascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke RESILIENT
• Scientific 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
• Date of first enrolment: February 8, 2017
• Target sample size: 221
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02216643
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Brazil

Contacts

• Name: Raul Nogueira, MD
• Affiliation: Emory University

• Name: Sheila CO Martins, MD
• Affiliation: Hospital de Clínicas de Porto Alegre

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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.

2. No significant pre-stroke functional disability (mRS = 1)

3. Baseline NIHSS score obtained prior to randomization must be equal or higher than 8
points

4. Age =18 years

5. 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.

6. 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.

7. Informed consent obtained from patient or acceptable patient surrogate

Exclusion Criteria:

1. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant
therapy with INR > 3.0

2. Baseline platelet count < 30.000/µL

3. Baseline blood glucose of < 50mg/dL or > 400mg/dl

4. 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.

5. 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).

6. Seizures at stroke onset which would preclude obtaining a baseline NIHSS

7. Serious, advanced, or terminal illness with anticipated life expectancy of less than
one year.

8. History of life threatening allergy (more than rash) to contrast medium

9. Subjects who has received IV t-PA treatment beyond 4,5 hours from the beginning of the
symptoms

10. Woman of childbearing potential who is known to be pregnant or lactating or who has a
positive pregnancy test on admission.

11. Subject participating in a study involving an investigational drug or device that
would impact this study.

12. Cerebral vasculitis

13. 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.)

14. Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor
from overseas).

15. 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.

16. Collaterals with malignant profile on CTA (without colateral circulation on CTA)

17. CT or MR evidence of hemorrhage (the presence of GRE microbleeds is allowed).

18. Significant mass effect with midline shift.

19. 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

20. Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior
circulation, or anterior/posterior circulation)

21. Evidence of intracranial tumor (except small meningioma).



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ischemic Stroke

Stroke

Intervention(s)

Procedure: Thrombectomy

Device: Stentriever Solitaire FR® or Penumbra System®

Primary Outcome(s)

Distribution of the modified Rankin Scale scores (shift analysis) [Time Frame: 90 days]

Secondary Outcome(s)

Mortality [Time Frame: 90 days]

Quality of life analysis [Time Frame: 3 months, 6 months, 1 year]

Dramatic early favorable response [Time Frame: 24 hours]

Symptomatic Intracranial hemorrhage [Time Frame: 24 hours]

Vessel recanalization at 24 hours [Time Frame: 24 hours]

Infarct Burden at 24 hours [Time Frame: 24 hours]

Cost effectiveness [Time Frame: Life-time horizon perspective]

Functional independence (modified Rankin Score = 2) [Time Frame: 90 days]

Procedure related complications [Time Frame: During the procedure]

Successful recanalization at the end of procedure [Time Frame: immediatelly after procedure (only thrombectomy arm)]

Secondary ID(s)

22042613.6.1001.5327

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ministry of Health, Brazil

Medtronic

Brainomix Limited

iSchemaView, Inc

Penumbra Inc.