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The Clinical Trial for Primary Chronic Venous Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00931424
Recruitment Status : Unknown
Verified May 2009 by Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : July 2, 2009
Last Update Posted : July 2, 2009
Information provided by:
Sun Yat-sen University

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

Condition or disease Intervention/treatment Phase
Primary Chronic Venous Insufficiency Procedure: valve reconstruction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Research of Surgery on Primary Chronic Venous Insufficiency
Study Start Date : January 2006
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: reconstruction
patients in this group will have both valve reconstruction and superficial vein surgery
Procedure: valve reconstruction
reconstruct valve at the same time of superficial vein surgery

No Intervention: unreconstruction
patients in this group will only have superficial vein surgery

Primary Outcome Measures :
  1. clinical-etiology-anatomic-pathophysiologic classification system [ Time Frame: 3 month, 1 year, 3 year, 5 year, 7 year ]

Secondary Outcome Measures :
  1. phlebography [ Time Frame: 3 month, 1 year, 3 year, 5 year, 7 year ]
  2. color doppler [ Time Frame: 3 month, 1 year, 3 year, 5 year, 7 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00931424

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Contact: Shen-ming Wang, Professor +86 020 87755766-8198

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China, Guang dong
The first affiliated hospital of Sun Yat-Sen University Recruiting
Guang Zhou, Guang dong, China, 510080
Contact: Shen-ming Wang, Doctor    +86 020 87755766-8198   
Principal Investigator: Shen-ming Wang, professor         
Sponsors and Collaborators
Sun Yat-sen University
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Study Chair: Shen-ming Wang, doctor First Affiliated Hospital, Sun Yat-Sen University
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Responsible Party: wang shen-ming, The first affiliated hospital of Sun Yat-Sen university Identifier: NCT00931424    
Other Study ID Numbers: 2008001
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: July 2, 2009
Last Verified: May 2009
Keywords provided by Sun Yat-sen University:
Primary Chronic Venous Insufficiency
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases