The Clinical Trial for Primary Chronic Venous Insufficiency

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2009 by Sun Yat-sen University
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00931424
First received: June 30, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • phlebography [ Time Frame: 3 month, 1 year, 3 year, 5 year, 7 year ] [ Designated as safety issue: No ]
  • color doppler [ Time Frame: 3 month, 1 year, 3 year, 5 year, 7 year ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00931424

Contacts
Contact: Shen-ming Wang, Professor +86 020 87755766-8198 shenmingwang@sohu.com

Locations
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    shenmingwang@sohu.com   
Principal Investigator: Shen-ming Wang, professor         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Chair: Shen-ming Wang, doctor First Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: wang shen-ming, The first affiliated hospital of Sun Yat-Sen university
ClinicalTrials.gov Identifier: NCT00931424     History of Changes
Other Study ID Numbers: 2008001
Study First Received: June 30, 2009
Last Updated: June 30, 2009
Health Authority: China:Ministry of Health of People's Republic of China

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

Additional relevant MeSH terms:
Venous Insufficiency
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014