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Trial record 1 of 1 for:    NCT03035747
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Ongoing Registry of Treatment of Chronic Venous Diseases (RRT CVD)

This study is currently recruiting participants.
Verified February 2017 by Evgeny Ilyukhin, Medalp Private Surgery Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT03035747
First Posted: January 30, 2017
Last Update Posted: February 2, 2017
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.
Collaborators:
Pirogov Russian National Research Medical University
Russian Phlebological Association
Information provided by (Responsible Party):
Evgeny Ilyukhin, Medalp Private Surgery Clinic
  Purpose
Ongoing registration of patients with varicose veins disease treated by means of conventional surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal methods

Condition Intervention
Varicose Veins of Lower Limb Procedure: conventional surgery Procedure: endovenous laser ablation Procedure: sclerotherapy Procedure: endovenous radiofrequency ablation Procedure: phlebectomy

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Russian Registry of Treatment of Chronic Venous Diseases

Resource links provided by NLM:


Further study details as provided by Evgeny Ilyukhin, Medalp Private Surgery Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1000
Actual Study Start Date: July 2016
Estimated Study Completion Date: July 2036
Estimated Primary Completion Date: July 2036 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing interventions in cases varicose vein disease
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no exclusion criteria
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT03035747


Contacts
Contact: Evgeny Ilyukhin, MD, PhD +79218451722 evgeny@ilyukhin.info

Locations
Russian Federation
Medalp private surgery clinic Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Oleg Shonov, MD       shonov.o@gmail.com   
Sponsors and Collaborators
Medalp Private Surgery Clinic
Pirogov Russian National Research Medical University
Russian Phlebological Association
  More Information

Additional Information:
Responsible Party: Evgeny Ilyukhin, Сhief surgeon Medalp Private Surgery Clinic, Medalp Private Surgery Clinic
ClinicalTrials.gov Identifier: NCT03035747     History of Changes
Other Study ID Numbers: A001
First Submitted: January 25, 2017
First Posted: January 30, 2017
Last Update Posted: February 2, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Evgeny Ilyukhin, Medalp Private Surgery Clinic:
registry
varicose veins
conventional surgery
thermal ablation
radiofrequency
laser
sclerotherapy

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases