Medina Embolization Device In Neurovascular Aneurysm Study | NCT02982200

Studies
Medina Embolization Device In Neurovascular Aneurysm Study

NCT02982200

Sponsor

Medtronic Neurovascular Clinical Affairs

Status

Terminated

Last Update Posted

May 17, 2019Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Intracranial Aneurysm

Interventions

Not provided

Countries

Austria
Italy
Spain

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

May 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2016Actual

Primary Completion Date

Oct 22, 2018Actual

Completion Date

Oct 22, 2018Actual

First Submitted Date

Dec 1, 2016

First Submission Date that Met QC Criteria

Dec 2, 2016

First Posted Date

Dec 5, 2016Estimated

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

May 16, 2019

Last Update Posted Date

May 17, 2019Actual

Name	Class
Medtronic Cardiac Rhythm and Heart Failure	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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 global prospective, multi-center, single-arm, post-market clinical follow-up (PMCF) study conducted to assess the performance of the Medina Embolization Device when used in unruptured and ruptured intracranial aneurysms.

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

15Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete aneurysm occlusion as defined by the Modified Raymond-Roy Classification (MRRC)		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject has provided written informed consent using the Ethics Committee-approved consent form and agrees to comply with protocol requirements
Subject is 18- 85 years old
Subject has a ruptured or unruptured saccular intra-cranial aneurysm amenable to be treated with the Medina Embolization Device

Exclusion Criteria:

Aneurysm is partially thrombosed
Aneurysm has been previously treated with surgery or endovascular therapy
Subject has had major brain surgery including endovascular procedures within the past 30 days
Vessel characteristics (tortuosity, stenosis, morphology) preclude safe endovascular access to the aneurysm
Subject is pregnant or breast-feeding or wishes to become pregnant during the length of the study participation
The Investigator determines that the validity of the study outcomes may be compromised by the subject's enrollment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Saccular intracranial aneurysm not previously treated.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick Brouwer, Dr	Karolinska University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Christian Doppler Klinik Salzburg		Salzburg		5020	Austria
Azienda Ospedaliera Ospedale Niguarda Cà Granda

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2244298	Background	Inagawa T, Hirano A. Autopsy study of unruptured incidental intracranial aneurysms. Surg Neurol. 1990 Dec;34(6):361-5. doi: 10.1016/0090-3019(90)90237-j.
23336985	Background	Agarwal N, Gala NB, Choudhry OJ, Assina R, Prestigiacomo CJ, Duffis EJ, Gandhi CD. Prevalence of asymptomatic incidental aneurysms: a review of 2,685 computed tomographic angiograms. World Neurosurg. 2014 Dec;82(6):1086-90. doi: 10.1016/j.wneu.2013.01.082. Epub 2013 Jan 19.

ID	Term
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases