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

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ClinicalTrials.gov Identifier: NCT03464565
Recruitment Status : Active, not recruiting
First Posted : March 14, 2018
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Brief Summary:
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).

Condition or disease Intervention/treatment
Stroke, Ischemic Device: Penumbra System

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Group/Cohort Intervention/treatment
Patients with acute ischemic stroke secondary to LVO Device: Penumbra System
Penumbra System




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464565


  Show 29 Study Locations
Sponsors and Collaborators
Penumbra Inc.
Investigators
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Principal Investigator: Osama O Zaidat, MD Mercy St. Vincent Medical Center
Principal Investigator: Johanna Fifi, MD Mount Sinai Health System
Principal Investigator: Ameer E. Hassan, MD McAllen Medical Center

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Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT03464565     History of Changes
Other Study ID Numbers: 12965
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Penumbra Inc.:
Large Vessel Occlusion
Acute Ischemic Stroke
Mechanical Thrombectomy
Penumbra System
3D Revascularization
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes