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The Clinical Trial for Primary Chronic Venous Insufficiency

Primary Purpose

Primary Chronic Venous Insufficiency

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
valve reconstruction
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Chronic Venous Insufficiency focused on measuring Primary Chronic Venous Insufficiency, surgery, reconstruction, valve

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The first affiliated hospital of Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

reconstruction

unreconstruction

Arm Description

patients in this group will have both valve reconstruction and superficial vein surgery

patients in this group will only have superficial vein surgery

Outcomes

Primary Outcome Measures

clinical-etiology-anatomic-pathophysiologic classification system

Secondary Outcome Measures

phlebography
color doppler

Full Information

First Posted
June 30, 2009
Last Updated
June 30, 2009
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT00931424
Brief Title
The Clinical Trial for Primary Chronic Venous Insufficiency
Official Title
The Clinical Research of Surgery on Primary Chronic Venous Insufficiency
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Chronic Venous Insufficiency
Keywords
Primary Chronic Venous Insufficiency, surgery, reconstruction, valve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
reconstruction
Arm Type
Experimental
Arm Description
patients in this group will have both valve reconstruction and superficial vein surgery
Arm Title
unreconstruction
Arm Type
No Intervention
Arm Description
patients in this group will only have superficial vein surgery
Intervention Type
Procedure
Intervention Name(s)
valve reconstruction
Intervention Description
reconstruct valve at the same time of superficial vein surgery
Primary Outcome Measure Information:
Title
clinical-etiology-anatomic-pathophysiologic classification system
Time Frame
3 month, 1 year, 3 year, 5 year, 7 year
Secondary Outcome Measure Information:
Title
phlebography
Time Frame
3 month, 1 year, 3 year, 5 year, 7 year
Title
color doppler
Time Frame
3 month, 1 year, 3 year, 5 year, 7 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shen-ming Wang, Professor
Phone
+86 020 87755766-8198
Email
shenmingwang@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen-ming Wang, doctor
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
The first affiliated hospital of Sun Yat-Sen University
City
Guang Zhou
State/Province
Guang dong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shen-ming Wang, Doctor
Phone
+86 020 87755766-8198
Email
shenmingwang@sohu.com
First Name & Middle Initial & Last Name & Degree
Shen-ming Wang, professor

12. IPD Sharing Statement

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The Clinical Trial for Primary Chronic Venous Insufficiency

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