ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embol... | NCT02533778

Studies
ARISE: After 8 Hours Reperfusion in Ischemic Stroke Embolization

NCT02533778

Sponsor

Abington Memorial Hospital

Status

Suspended

Last Update Posted

Aug 2, 2017Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Ischemic Stroke

Interventions

mechanical thrombectomy

Countries

United States

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

Jul 2017

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Similar large international competing trial with results of strong positive statistically benefit

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Jul 1, 2018Estimated

Completion Date

Jul 1, 2018Estimated

First Submitted Date

Jul 14, 2015

First Submission Date that Met QC Criteria

Aug 25, 2015

First Posted Date

Aug 27, 2015Estimated

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

Jul 31, 2017

Last Update Posted Date

Aug 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

A prospective pilot study to evaluate the recanalization and safety of mechanical thrombectomy through a cerebral angiogram in patients with stroke symptoms last seen normal between 8 - 24 hours.

Detailed Description

Ischemic stroke patients who are 8-24 hrs from symptom onset without prior mechanical or IV thrombolytic treatment and are screen with CT or MR perfusion imaging showing penumbra and infarction not > 1/3rd the territory.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventional mechanical thrombectomy	Experimental	Mechanical thrombectomy with either Penumbra system, TREVO, or Solitaire device for acute stroke symptom onset between 8 - 24 hours	Device: mechanical thrombectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mechanical thrombectomy	Device	Mechanical thrombectomy by either Penumbra system, TREVO, or Solitaire retrieval device	Interventional mechanical thrombectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Thrombolysis in Cerebral Infarction (TICI) score		6 months

Secondary Outcomes

Measure	Description	Time Frame
National Institutes of Health Stroke Scale (NIHSS) score		6 months
Montreal Cognitive Assessment (MoCA) tool		6 months
Modified Rankin Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 18 years last seen normal between 8 - 24 hours, without prior history of intravenous plasminogen activator (IV t-PA ) or
mechanical thrombectomy Vessels - intracranial vertebral artery, basilar artery, intracranial ICA, ICA terminus bifurcation, MCA M1/M2, or
ACA NIHSS ≥ 7 MRI DWI/PWI or
CTA/P, which demonstrates an area of mismatch ≥ 2/3 rd
Signed informed consent

Exclusion Criteria:

creat >= 2
NIHSS < 7
Baseline mRS >= 2
infarct > 1/3rd MCA territory
competing trials
prior IV or IA treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Qaisar Shah, MD	Abington Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abington Memorial Hospital		Abington	Pennsylvania	19001	United States

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

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided