Evaluation of Peripheral EOS for the Peripheral Embolizat... | NCT02033954

Studies
Evaluation of Peripheral EOS for the Peripheral Embolization Treatment to Rapidly OccluDe Venous or Arterial BleEding

NCT02033954

Sponsor

ArtVentive Medical Group, Inc.

Status

Unknown status

Last Update Posted

Jun 24, 2015Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Hemorrhage
Bleeding

Interventions

Not provided

Countries

Austria
Belgium
Germany

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

Jun 2015

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

Jul 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Jan 8, 2014

First Submission Date that Met QC Criteria

Jan 10, 2014

First Posted Date

Jan 13, 2014Estimated

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

Jun 22, 2015

Last Update Posted Date

Jun 24, 2015Estimated

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

To collect confirmatory data in support of the safety and performance of the ArtVentive Medical Group Endoluminal Occlusion System.

Detailed Description

Prospective, non-randomized, multi-center confirmatory observational study for the treatment of subjects with the need for vascular occlusion for the following conditions:

Stopping blood loss from a damaged blood vessel from a traumatic vascular injury
Hemorrhage caused by a neoplasia
Neoplastic process (tumor)
Gastrointestinal bleeding
Closing an abnormal blood vessel supplying a vascular anomaly such as arteriovenous malformations or an arteriovenous fistula
Interrupting blood supply to an organ or part of an organ for permanent devascularization
Devascularization of tissues involved by a neoplastic process either pre-operatively or as a palliative measure
Transjugular Intrahepatic Portosystemic Shunt (TIPS)

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

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety	Composite of new-onset major device-related adverse event(s) including device embolization beyond targeted treatment area (not therapeutic indication of embolization), need for emergency surgical intervention of the target vessel, or distal embolization (non-device embolization, e.g., particulate matter / plague distal to the device) at 30 days.	Acute & 30 days

Secondary Outcomes

Measure	Description	Time Frame
Occlusion	Sustained occlusion at 30 days follow-up.	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects aged ≥18 to ≤75 years.
Subject with target vessels of 3.0 mm to 12 mm in diameter.
Subject is able and willing to comply with all study requirements, including the required study follow-up visits.
Subject or subject's legal representative have been informed of the nature of the study, agrees to participate and has signed the consent form. In the event of emergency procedure and subject and/or legal representative is unable to provide consent prior to study enrollment, consent will be obtained at earliest possible time following procedure for consent to continue to participate in the study.

Exclusion Criteria:

Subject has a known allergy to iodinated contrast for which they cannot be adequately premedicated.
Subjects in whom venography or arteriography is contraindicated.
Subjects with known hypersensitivity or contraindication to nickel or nitinol.
Subject is pregnant or breastfeeding.
Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects requiring permanent occlusion of the peripheral vessels for the following conditions:

Stopping blood loss from a damaged blood vessel from a traumatic vascular injury
Hemorrhage caused by a neoplasia
Neoplastic process (tumor)
Gastrointestinal bleeding
Closing an abnormal blood vessel supplying a vascular anomaly such as arteriovenous malformations or an arteriovenous fistula
Interrupting blood supply to an organ or part of an organ for permanent devascularization
Devascularization of tissues involved by a neoplastic process either pre-operatively or as a palliative measure.
Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Leon Rudakov, PhD	Contact	+1 (760) 471-7700		leonrudakov@artventivemedical.com

Name	Affiliation	Role
Andreas Mahnken, Prof Dr	Universitätsklinikum Giessen und Marburg (UKGM) Klinik für diagnostische und	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Klagenfurt am Worthersee	Recruiting	Klagenfurt			Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23703667	Background	Venbrux AC, Rudakov L, Plass A, Emmert MY, Ebner A. A new occlusion device: application of the ArtVentive endoluminal occlusion system (EOS)--first in human clinical trial. Cardiovasc Intervent Radiol. 2014 Feb;37(1):85-93. doi: 10.1007/s00270-013-0626-y. Epub 2013 May 24.

ID	Term
D006470	Hemorrhage
D006471	Gastrointestinal Hemorrhage
D001164	Arteriovenous Fistula
D001165	Arteriovenous Malformations

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases