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Completed

NCT Number: NCT03993340

Rescue Stenting for Failed Endovascular Thrombectomy in Acute Ischemic Stroke (ReSET)

This study is a prospective, open-label, multi-center, registry study, designed to show that rescue stenting is safe and effective for emergency large vessel occlusion (ELVO) patients who have mechanical thrombectomy failure. Participants with ELVO will initially underwent mechanical thrombectomy usig stent retriever, contact aspiration or both. After failure of mechanical thrombectomy, rescue stenting will be performed.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Artery Occlusion Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Severance Hospital Stroke Center, Yonsei University College of Medicine

Seoul, Yeonsei-ro Seodaemun-gu, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Subjects experiencing acute ischemic stroke due to large vessel occlusion (intracranial internal carotid artery and middle cerebral artery M1 segment)
  • 2. Age 19 or greater
  • 3. mRS before qualifying stroke, 0 or 1
  • 4. Baseline NIHSS score 4 or more
  • 5. CT ASPECTS > 6 or MR ASPECTS > 5
  • 6. Good collateral statues on CT angiogram (collateral grade by Calgary group, 4 or 5) or corresponding to DEFUSE 3 or DAWN trial on perfusion imaging.
  • 7. Onset (last-seen-well) time to femoral puncture time < 24 hours
  • 8. Failure of mechanical thrombectomy with stent retriever, contact aspiration or both
  • 9. Subjects who received rescue stenting after failure of mechanical thrombectomy
  • 10. Anticipated life expectancy of at least 12 months
  • 11. Signed informed consent for study enrollment

Exclusion criteria

  • 1. Any contraindication to antiplatelet medication
  • 2. Multiple simultaneous large vessel occlusions
  • 3. Pregnancy
  • 4. Severe contrast allergy or absolute contraindication to iodinated contrast agent
  • 5. Patient has a severe or fatal combined illness that will prevent improvement of follow-up or will render the procedure unlikely to benefit the patient.

Treatment and study plan

Rescue stenting

Device

The subjects will receive endovascular treatment for acute stroke according to standard clinical practice. Specifically, modern endovascular thrombectomy using a stent retriever, contact aspiration thrombectomy, or both are allowed. The number of thrombectomy attempts is at the operator's discretion. After failure of standard thrombectomy procedure, rescue stenting with Solitaire will be done. Additional balloon angioplasty, glycoprotein IIb/IIIa inhibitor (GPI), or thrombolytic infusions are optional and at the operator's discretion. After successful recanalization with rescue stenting, intravenous maintenance of GPI at least for a 12 hours and then changed to oral antiplatelet are recommended.

Primary outcomes

  1. modified Rankin scale

    Time frame: 3 months

    The rate of good functional outcome defined by modified Rankin Scale score, 0 - 2

Secondary outcomes

  1. Patency of the target artery

    Time frame: 1 day to 28 days

    The rate of patency of the treated artery at follow-up vascular imaging (magnetic resonance angiography, computed tomography angiography, or catheter angiography)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 20, 2019
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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