COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
|ClinicalTrials.gov Identifier: NCT03464565|
Recruitment Status : Active, not recruiting
First Posted : March 14, 2018
Last Update Posted : November 1, 2019
|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|
|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|
|Patients with acute ischemic stroke secondary to LVO||
Device: 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464565
Show 29 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|