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The Clinical Trial for Primary Chronic Venous Insufficiency

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Sun Yat-sen University.
Recruitment status was:  Recruiting
Information provided by:
Sun Yat-sen University Identifier:
First received: June 30, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
A multicenter Random Clinical Trial to confirm the advantage of the valve reconstructive surgery on Primary Chronic Venous Insufficiency.

Condition Intervention
Primary Chronic Venous Insufficiency Procedure: valve reconstruction

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Sun Yat-sen University:

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

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

Estimated Enrollment: 400
Study Start Date: January 2006
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00931424

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

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
Study Chair: Shen-ming Wang, doctor First Affiliated Hospital, Sun Yat-Sen University
  More Information

Responsible Party: wang shen-ming, The first affiliated hospital of Sun Yat-Sen university Identifier: NCT00931424     History of Changes
Other Study ID Numbers: 2008001
Study First Received: June 30, 2009
Last Updated: June 30, 2009

Keywords provided by Sun Yat-sen University:
Primary Chronic Venous Insufficiency

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases processed this record on September 21, 2017