The Safety & Efficacy of Endovenous Laser Ablation of Superficial Vein in Patients with Combined Superficial and Segmental Deep Venous Disease.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- safety & efficacy of endovenous laser ablation of superficial veins in patients with combined superficial and segmental deep venous disease
Study Overview
Brief Summary
Great saphenous vein (GSV) reflux is important in the development of signs and symptoms of chronic venous insufficiency. The combination of varicose veins and deep vein thrombosis (DVT) / deep venous insufficiency is a common clinical scenario. In the presence of combined superficial and deep vein reflux, it is always possible to treat superficial reflux.
This is a single-center, single-arm, prospective interventional study to evaluate the safety & efficacy of Endo-venous laser ablation of the superficial saphenous veins in patients combined with superficial & deep venous disease. The primary outcome measures will be the improvement in venous clinical severity score at 1 & 3 months & secondary outcome measures will be to evaluate the technical success rate & the incidence of recurrent DVT post-procedure, other complications, and recurrence of varicose veins at 1 & 3 months.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •patients with varicose veins with both superficial & deep venous reflux patient with >70% recanalized chronic deep venous thrombosis with superficial reflux patients with post-thrombotic varicose veins with superficial reflux will be included in the study.
Exclusion Criteria
- •1.Patient with acute DVT.
- •2.Pregnancy.
- •3.Patients on chronic hemodialysis.
- •4.Non-consenting patients.
Outcomes
Primary Outcomes
safety & efficacy of endovenous laser ablation of superficial veins in patients with combined superficial and segmental deep venous disease
Time Frame: POST OPERATIVE DAY 1, 1 MONTH & 3 MONTH
Secondary Outcomes
- rate of technical success, the incidence of recurrent DVT post procedure, other complications, and recurrence of varicose veins.(POST OPERATIVE DAY 1, 1 MONTH & 3 MONTHS.)