Delayed or Immediate Local Treatment of Veins
DELICATVE
1 other identifier
interventional
140
1 country
1
Brief Summary
Varicose veins affect a majority of adult patients and cause a decreased quality of life. In recent years, standard practice has been to perform thermoablation and local phlebectomies in the same procedure. There is conflicting data on the long-term outcome of the local varicose veins; there seems to be a need for more re-interventions if the local varicosities are not treated immediately. On the other hand, the prolonged combined procedure increases procedural pain and bleeding, as well as the risk for complications from deep vein thrombosis/pulmonary embolism. This trial aims to evaluate the need for immediate treatment of local varicosities and the potential sufficiency of main trunk treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 4, 2016
CompletedFirst Submitted
Initial submission to the registry
October 13, 2017
CompletedFirst Posted
Study publicly available on registry
November 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedAugust 9, 2022
August 1, 2022
4.6 years
October 13, 2017
August 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Need for sclerotherapy
Need for sclerotherapy of varicosities at three months after ablation of main trunk. Evaluated by the CEAP-classification of venous insufficiency. \>C2 will be eligible for treatment.
3 months
Secondary Outcomes (2)
Patient satisfaction
3 months
Occlusion rate of great saphenous vein
36 months
Study Arms (2)
Immediate phlebectomy
ACTIVE COMPARATORMechanochemical ablation of main trunk and immediate phlebectomy of varicosities
Delayed treatment
EXPERIMENTALMechanochemical ablation of main trunk. Evaluation of varicosities at 3 months with sclerotherapy if required
Interventions
Eligibility Criteria
You may qualify if:
- Ultrasound verified insufficiency of great saphenous vein (GSV)
- GSV diameter 5-10 mm
- C2-C4 varicosities
- Most proximal insufficient branch in the distal thigh
- Written and signed informed consent
You may not qualify if:
- Peripheral arterial disease
- Body mass index \>40
- Lymphoedema
- Known allergy to sclerosant
- Any known coagulopathy or history of deep vein thrombosis
- Severe illness
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Helsinki University Hospital
Helsinki, 00029, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karoliina Halmesmäki, M.D., Ph.D
Helsinki University Central Hospital
- STUDY DIRECTOR
Maarit Venermo, M.D., Ph.D.
Helsinki University Central Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Vascular Surgery
Study Record Dates
First Submitted
October 13, 2017
First Posted
November 13, 2017
Study Start
May 4, 2016
Primary Completion
December 20, 2020
Study Completion
December 31, 2022
Last Updated
August 9, 2022
Record last verified: 2022-08