Evaluation of the Sinus-Venous Stent for the Treatment of... | NCT02799914

Studies
Evaluation of the Sinus-Venous Stent for the Treatment of Iliofemoral Venous Occlusive Disease

NCT02799914

Sponsor

be Medical

Status

Withdrawn

Last Update Posted

Feb 8, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Venous Vascular Diseases and Syndromes

Interventions

Sinus-Venous stent (Optimed GmbH)

Countries

Belgium

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

Nov 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficult patient recruitment. No patients enrolled.

Expanded Access Info

Start Date

Apr 2016Actual

Primary Completion Date

Jun 2018Actual

Completion Date

Jun 2018Actual

First Submitted Date

Dec 7, 2015

First Submission Date that Met QC Criteria

Jun 10, 2016

First Posted Date

Jun 15, 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

Feb 7, 2019

Last Update Posted Date

Feb 8, 2019Actual

Name	Class
Archer Research	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

Post market clinical follow-up study about the Sinus-venous stent. Patients with venous iliofemoral occlusive disease are treated with the Sinus-venous stent. This observational study will provide 1 year data about safety and efficacy.

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

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Sinus-Venous stent (Optimed GmbH)	Device	Stent implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stent patency	Patency broken down in primary patency, assisted primary patency and secondary patency	12 months

Secondary Outcomes

Measure	Description	Time Frame
Technical success	The index-procedure is the endovascular procedure in which the patient receives the device.	Index-procedure (intraoperative)
Revised venous clinical severity score		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age at study entry is at least 18 years.
Patient must sign the informed consent form prior to the index-procedure.
Patient suffers from acute or chronic venous occlusive disease indicated to be treated with a venous stent.
Target lesion is located in the femoral vein, common femoral vein, external iliac vein, or common iliac vein.

Exclusion Criteria:

Intolerance to anticoagulant medication.
Contra-indication for prolonged anticoagulant treatment.
Life expectancy less than 1 year.
Target vessel has been stented before.
Coagulopathy or known uncorrectable bleeding diathesis.
Recent (<1 year) pulmonary embolism.
Pregnancy.
Known hypersensitivity to nitinol and/or nickel.
Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history).
Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study.
Patients in custody by juridical order.
Patients who do not agree to the transmission of their coded data within the liability of documentation and notification.
Close affiliation with the investigational site: e.g. a close relative of the investigator or a possibly dependent person (e.g. employee or student of the investigational site).

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 venous iliofemoral occlusive disease.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Geert Lauwers, MD	Ziekenhuis Oost-Limburg	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Ziekenhuis Oost-Limburg		Genk		3600	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D004194	Disease
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms