Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ongoing Registry of Treatment of Chronic Venous Diseases (RRT CVD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03035747
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Pirogov Russian National Research Medical University
Information provided by (Responsible Party):
Evgeny Ilyukhin, Medalp Private Surgery Clinic

Tracking Information
First Submitted Date January 25, 2017
First Posted Date January 30, 2017
Last Update Posted Date March 22, 2018
Actual Study Start Date July 2016
Estimated Primary Completion Date July 2036   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2017)
Change in patency target veins assessed by duplex ultrasonography in different follow up periods after conventional surgery, endovenous thermal ablations, sclerotherapy or non-tumescent non-thermal methods [ Time Frame: Baseline, 3 - 6, 12 months post-intervention ]
Original Primary Outcome Measures
 (submitted: January 26, 2017)
Change in patency target veins assessed by duplex ultrasonography in different follow up periods [ Time Frame: Baseline, 3 - 6, 12 months post-intervention ]
Change History Complete list of historical versions of study NCT03035747 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 26, 2017)
  • Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey (optional) [ Time Frame: Baseline, 3 and 12 months post-intervention ]
    The SF-36 is a generic QoL questionnaire.
  • Change in Venous Clinical Severity Score (VCSS) (optional) [ Time Frame: Baseline, 3 and 12 months post-intervention ]
    The VCSS is a validated scoring system for assessing signs, symptoms and complaints of venous disease.
  • Change in Quality of Life (QoL), assessed by Aberdeen Varicose Vein Questionnaire (AVVQ) (optional) [ Time Frame: Baseline, 3 and 12 months post-intervention ]
    The AVVQ is a disease-specific QoL questionnaire aimed at venous disease.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ongoing Registry of Treatment of Chronic Venous Diseases
Official Title Russian Registry of Treatment of Chronic Venous Diseases
Brief Summary Ongoing registration of patients with varicose veins disease treated by means of conventional surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal methods
Detailed Description

Data of patients treated in different Russian medical centers are entered in a prospective digital database, and continuously updated.

There is planned to conduct prospective randomized, cohort and observational studies on the site of register

Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing interventions in cases varicose vein disease
Condition Varicose Veins of Lower Limb
Intervention
  • Procedure: conventional surgery
    high ligation and stripping of incompetent saphenous veins
  • Procedure: endovenous laser ablation
    endovenous laser ablation of incompetent saphenous veins
  • Procedure: sclerotherapy
    ultrasound guided or catheter or or any other methods sclerotherapy of incompetent saphenous or varicose veins
  • Procedure: endovenous radiofrequency ablation
    endovenous radiofrequency ablation of incompetent saphenous veins
  • Procedure: phlebectomy
    hooks phlebectomy of varicose veins
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 20, 2018)
5000
Original Estimated Enrollment
 (submitted: January 26, 2017)
1000
Estimated Study Completion Date July 2036
Estimated Primary Completion Date July 2036   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Varicose veins with any source of pathological reflux, C2 - C6 according to the CEAP classification

Exclusion Criteria:

  • no exclusion criteria
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Evgeny Ilyukhin, MD, PhD +79218451722 evgeny@ilyukhin.info
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT03035747
Other Study ID Numbers A001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Evgeny Ilyukhin, Medalp Private Surgery Clinic
Study Sponsor Medalp Private Surgery Clinic
Collaborators Pirogov Russian National Research Medical University
Investigators Not Provided
PRS Account Medalp Private Surgery Clinic
Verification Date March 2018