Venous Thrombectomy/Thrombolysis Outcome Registry | NCT02113475

Studies
Venous Thrombectomy/Thrombolysis Outcome Registry

NCT02113475

Sponsor

Heart and Vascular Outcomes Research Institute

Status

Unknown status

Last Update Posted

Mar 19, 2015Estimated

Enrollment

1,800Estimated

Phase

Not provided

Conditions

Deep Venous Thrombosis
Post Thrombotic Syndrome

Interventions

Not provided

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

Mar 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

Apr 2014

Primary Completion Date

Mar 2020Estimated

Completion Date

Jan 2021Estimated

First Submitted Date

Apr 9, 2014

First Submission Date that Met QC Criteria

Apr 10, 2014

First Posted Date

Apr 14, 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

Mar 18, 2015

Last Update Posted Date

Mar 19, 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

Deep Venous Thrombosis affects more than 350,000 individuals each year in the U.S.The Registry will track patient outcome and quality of life over 60 months for treatment with anticoagulation and elastic compression stockings and catheter-directed thrombolysis (CDT) in accordance with current treatment guidelines .

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

1,800Estimated

Measure	Description	Time Frame
Quality of Life,		60 months

Measure	Description	Time Frame
Rate of Post-Thrombotic Syndrome		60 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

•Data obtained in line with good clinical practice, applicable laws and regulation

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Participating study centers will enroll patients and enter data in the web-based registry that include demographics, clinical features,

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Uchenna N Onyeachom	Contact	978-927-7800		uonyeachom@hvori.org

Overall Officials

Name	Affiliation	Role
Uchenna N Onyeachom	Heart and Vascular Outcomes Research Institute	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heart & Vascular Outcomes Research Institute	Recruiting	Beverly	Massachusetts	01915	United States

Condition Browse Module

MeSH Terms

ID	Term
D020246	Venous Thrombosis
D054070	Postthrombotic Syndrome

Ancestor Terms

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided