The Clinical Trial for Primary Chronic Venous Insufficiency | NCT00931424

Studies
The Clinical Trial for Primary Chronic Venous Insufficiency

NCT00931424

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Jul 2, 2009Estimated

Enrollment

400Estimated

Phase

Not Applicable

Conditions

Primary Chronic Venous Insufficiency

Interventions

valve reconstruction

Countries

China

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 2009

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

Jan 2006

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Jun 30, 2009

First Submission Date that Met QC Criteria

Jun 30, 2009

First Posted Date

Jul 2, 2009Estimated

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 30, 2009

Last Update Posted Date

Jul 2, 2009Estimated

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

A multicenter Random Clinical Trial to confirm the advantage of the valve reconstructive surgery on Primary Chronic Venous Insufficiency.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
reconstruction	Experimental	patients in this group will have both valve reconstruction and superficial vein surgery	Procedure: valve reconstruction
unreconstruction	No Intervention	patients in this group will only have superficial vein surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
valve reconstruction	Procedure	reconstruct valve at the same time of superficial vein surgery	reconstruction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical-etiology-anatomic-pathophysiologic classification system		3 month, 1 year, 3 year, 5 year, 7 year

Secondary Outcomes

Measure	Description	Time Frame
phlebography		3 month, 1 year, 3 year, 5 year, 7 year
color doppler		3 month, 1 year, 3 year, 5 year, 7 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PCVI patients with III degree back flow in deep vein that is confirmed by color doppler or phlebography

Exclusion Criteria:

age over 70 years old
pregnancy
patients with severity arteriosclerosis obliterans, malignancy, severity disease of heart, lung or brain, and hematopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shen-ming Wang, Professor	Contact	+86 020 87755766-8198		shenmingwang@sohu.com

Overall Officials

Name	Affiliation	Role
Shen-ming Wang, doctor	First Affiliated Hospital, Sun Yat-Sen University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The first affiliated hospital of Sun Yat-Sen University	Recruiting	Guangzhou	Guangdong	510080	China