COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
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| ClinicalTrials.gov Identifier: NCT03464565 |
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Recruitment Status :
Completed
First Posted : March 14, 2018
Last Update Posted : December 22, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| Stroke, Ischemic | Device: Penumbra System |
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.
| 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 |
| Actual Primary Completion Date : | January 17, 2020 |
| Actual Study Completion Date : | January 17, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
| Patients with acute ischemic stroke secondary to LVO |
Device: Penumbra System
Penumbra System |
- 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.
- 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.
- All-cause mortality at 90 days [ Time Frame: 90 days ]All-cause mortality at 90 days
- Incidence of device and procedure related Serious Adverse Events (SAEs) [ Time Frame: Within 24 hours of procedure ]
- 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
- Occurrence of symptomatic intracranial hemorrhages (sICH) [ Time Frame: 24 Hours Post Procedure ]
- Time to Revascularization [ Time Frame: During Procedure ]
- Length of hospital stay [ Time Frame: Through discharge, up to study completion at approximately 90 days ]
- 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 |
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.
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 42 study locations
| 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 |
| Responsible Party: | Penumbra Inc. |
| ClinicalTrials.gov Identifier: | NCT03464565 |
| Other Study ID Numbers: |
12965 |
| First Posted: | March 14, 2018 Key Record Dates |
| Last Update Posted: | December 22, 2020 |
| Last Verified: | December 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Large Vessel Occlusion Acute Ischemic Stroke Mechanical Thrombectomy Penumbra System 3D Revascularization |
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Stroke Ischemic Stroke Ischemia Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes |