Flow Arrest Safety and Technical Success With Balloon Gui... | NCT04416659

Studies
Flow Arrest Safety and Technical Success With Balloon Guide Catheters

NCT04416659

Sponsor

Medtronic Neurovascular Clinical Affairs

Status

Completed

Last Update Posted

Apr 28, 2022Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Acute Ischemic Stroke

Interventions

Neuro-vascular access

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

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 12, 2021Actual

Primary Completion Date

Oct 27, 2021Actual

Completion Date

Oct 27, 2021Actual

First Submitted Date

May 21, 2020

First Submission Date that Met QC Criteria

Jun 3, 2020

First Posted Date

Jun 4, 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

Apr 21, 2022

Last Update Posted Date

Apr 28, 2022Actual

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

The objective of this post-market registry is to assess technical efficacy and safety associated with the use of the BOSS Balloon Guide Catheter during neuro-vascular procedures while providing temporary arrest of blood flow.

Detailed Description

This is a prospective, multi-center, non-randomized observational registry evaluating use of BOSS balloon guide catheters in patients diagnosed with an acute ischemic stroke due to large intracranial vessel occlusion.

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

1 Week

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuro-vascular access	Device	Adjunctive device providing a conduit for retrieval device during thrombectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety Evaluation	Incidence of device-related adverse events	Hospital discharge or 7 days
Performance Evaluation	Technical success of the BGC during procedure which includes inflation, deflation, retraction, flow arrest and reestablishment	Completion of procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute ischemic stroke vessel occlusion (ICA, M1 or M2) of the anterior circulation with associated symptoms
Adult patient willing to provide Informed Consent
Pre-treatment National Institutes of Health Stroke Scale (NIHSS) ≥ 6

Exclusion Criteria:

Posterior circulation stroke
Tandem occlusions
Cervical carotid stenosis
Participating in another clinical trial

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

Patients with acute ischemic stroke

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Biraj Patel, MD	Carilion Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BNI (St. Joseph's Hospital-Dignity Health)		Phoenix	Arizona	85013	United States
Swedish-RIACO

IPD Sharing Statement Module

Plan to Share IPD

Description

No IPD will be available.

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