Back to resultsThe 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
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
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
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
Learn more about this trial
The Clinical Trial for Primary Chronic Venous Insufficiency
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