Stent Thrombosis After Tandem Lesions Thrombectomy | NCT03588780

Studies
Stent Thrombosis After Tandem Lesions Thrombectomy

NCT03588780

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Sep 21, 2018Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Acute Stroke With Large Vessel Occlusion

Interventions

Not provided

Countries

France

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 2018

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

Aug 6, 2018Actual

Primary Completion Date

Oct 2018Estimated

Completion Date

Oct 2018Estimated

First Submitted Date

Jul 3, 2018

First Submission Date that Met QC Criteria

Jul 3, 2018

First Posted Date

Jul 17, 2018Actual

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

Sep 19, 2018

Last Update Posted Date

Sep 21, 2018Actual

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 aim is to describe the rate of delayed stent thrombosis after endovascular management of consecutive tandem lesions, in a patient series with systematic follow-up of stent patency. In addition, Investigatros aim to research baseline patient characteristics that are associated with a higher risk of delayed stent thrombosis and to evaluate the clinical consequences of stent thrombosis

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stent thrombosis rate		participants will be followed for the duration of hospital stay, an expected average 15 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent endovascular treatments for acute ischemic stroke in Strasbourg University Hospitals between 01/01/2009 and 01/04/2018
Association of extracranial internal carotid artery (ICA) occlusion or stenosis ≥70% using NASCET criteria and an intracranial arterial occlusion in the anterior circulation

Exclusion Criteria:

- Endovascular treatments for complication of surgical carotid endarterectomy

Accepts Healthy Volunteers

Not provided

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 who underwent endovascular treatments for acute ischemic stroke in Strasbourg University Hospitals between 01/01/2009 and 01/04/2018

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rémy BEAUJEUX, MD, PhD	Contact	33 3 88 12 78 71		remy.beaujeux@chru-strasbourg.fr
Raoul POP, MD	Contact	33 3 88 12 78 71		raoul.pop@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Rémy BEAUJEUX, MD, PhD	University Hospital, Strasbourg, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Neuroradiologie Interventionnelle	Recruiting	Strasbourg		67098	France

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided