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Completed

NCT Number: NCT03464565

COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device

The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux - Hôpital Pellegrin, Bordeaux, France

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About this study

Registry Objective: The primary objective of this registry is to collect real-world performance and safety data on Penumbra System including the 3D Revascularization Device in a patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

Registry Design: This will be a prospective, single-arm, multi-center observational registry and will include patients that present with either anterior or posterior LVO who are eligible for mechanical thrombectomy using the Penumbra System.

Registry Duration: Subjects will be in the registry for approximately 90 days from enrollment to last follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient age ≥ 18
  • Pre-stroke mRS 0-1
  • Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
  • Planned frontline treatment with Penumbra System
  • Signed informed consent per Institution Review Board/Ethics Committee

Exclusion criteria

  • Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days.
  • Currently participating in an investigational (drug, device, etc) clinical trial that will confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.

Treatment and study plan

Penumbra System

Device

Penumbra System

Primary outcomes

  1. mTICI Score

    Time frame: Post Procedure

    Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score 2b or higher.

    mTICI scale ranges 0 to 3 higher values represent better outcomes.

  2. Functional Subject Outcome

    Time frame: 90 days post

    Functional subject outcome at 90 days post-procedure as defined by a modified Rankin Scale (mRS) 0-2.

    mRS scale ranges 0 to 6 higher values represent a worse outcome.

  3. All-cause mortality at 90 days

    Time frame: 90 days

    All-cause mortality at 90 days

Secondary outcomes

  1. Incidence of device and procedure related Serious Adverse Events (SAEs)

    Time frame: Within 24 hours of procedure

  2. Occurrence of embolization in previously uninvolved (or new) territories (ENT)

    Time frame: During Procedure

    Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure

  3. Occurrence of symptomatic intracranial hemorrhages (sICH)

    Time frame: 24 Hours Post Procedure

  4. Time to Revascularization

    Time frame: During Procedure

  5. Length of hospital stay

    Time frame: Through discharge, up to study completion at approximately 90 days

  6. Discharge Facility

    Time frame: Through discharge, up to study completion at approximately 90 days

Sponsors and collaborators

Lead sponsor

Penumbra Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 14, 2018
Registry last updated
Dec 22, 2020

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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