First-pass Recanalization With EmboTrap II in Acute Ische... | NCT04310306

Studies
First-pass Recanalization With EmboTrap II in Acute Ischemic Stroke (FREE-AIS)

NCT04310306

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Mar 17, 2020Actual

Enrollment

310Estimated

Phase

Not provided

Conditions

Acute Ischemic Stroke Due to Intracranial Large Artery Occlusion

Interventions

Thrombectomy using EmboTrap II

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2020Actual

Primary Completion Date

Dec 30, 2021Estimated

Completion Date

Dec 30, 2021Estimated

First Submitted Date

Mar 13, 2020

First Submission Date that Met QC Criteria

Mar 13, 2020

First Posted Date

Mar 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2020

Last Update Posted Date

Mar 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a prospective, open-label, multi-center, registry study, designed to to documents that EmboTrap II usage as a thrombectomy device for emergency large vessel occlusion (ELVO) in terms of the rate of First Pass Recanalization (FPR). Patients with ELVO will initially underwent mechanical thrombectomy usig EmboTrap II. FPR is defined as modified Tissue Thrombolysis In Cerebral Ischemia (mTICI) 2b or 3

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

310Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rescue stenting group			Device: Thrombectomy using EmboTrap II

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thrombectomy using EmboTrap II	Device	The subjects will receive endovascular treatment for acute stroke according to standard clinical practice. Specifically, using a stent retriever, contact aspiration EmboTrap II. The number of thrombectomy attempts is at the operator's discretion. Combination of balloon guide catheter or intermediate catheter is recommended.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First Pass Recanalization (FPR) rate	The rate of FPR defined by modified TICI 2b or 3	Within 1 day after the completion of endovascular thrombectomyh

Secondary Outcomes

Measure	Description	Time Frame
The rate of modified Rankin scale 0-2 at 3 months after treatment	The rate of modified Rankin Scale score (mRS), 0-2 at 90 days ± 14 days	90 days ± 14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects experiencing acute ischemic stroke due to large vessel occlusion (intracranial internal carotid artery and middle cerebral artery M1 or proximal M2 segment, intracranial vertebral artery and basilar artery
Age 19 or greater
mRS before qualifying stroke, 0 to 2
Baseline NIHSS score 4 or more
CT ASPECTS > 5 or MR ASPECTS > 4
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.
Onset (last-seen-well) time to femoral puncture time < 24 hours
Anticipated life expectancy of at least 12 months
Patients who undergo endovascular thrombectomy with EmboTrap II as the first-line device
Signed informed consent for study enrollment

Exclusion Criteria:

Multiple simultaneous large vessel occlusions
Pregnancy
Severe contrast allergy or absolute contraindication to iodinated contrast agent
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with acute stroke due to ELVO within 24 hours after last seen well

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Byung Moon Kim, PhD	Contact	82-2-2228-2399		bmoon21@yuhs.ac

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital Stroke Center, Yonsei University College of Medicine	Recruiting	Seongdu			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided