Laser crossectomy with 1470 nm versus 1940 nm to prevent varicose vein recurrence
The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression
This will test whether doing a flush laser crossectomy with either a 1470 nm or 1940 nm laser lowers the chance of varicose vein recurrence and heat-related clots in adults with great saphenous vein reflux.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pirogov Russian National Research Medical University Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07449728 on ClinicalTrials.gov |
What this trial studies
Adults with primary great saphenous vein reflux (CEAP C2–C6, GSV diameter ≤12 mm, reflux >0.5 s) will receive one of three endovenous approaches: laser crossectomy with 1470 nm, laser crossectomy with 1940 nm, or standard endovenous laser treatment leaving a stump. The trial compares technical success, recurrence at the sapheno-femoral junction, postoperative pain intensity, and rates of endovenous heat-induced thrombosis using clinical and ultrasound follow-up. Investigators expect similar technical efficacy between the two wavelengths but will look for differences in pain and adverse events. Procedures are performed at a single center with standard exclusion criteria to reduce thrombotic risk and with informed consent.
Who should consider this trial
Good fit: Adults over 18 with primary varicose veins (CEAP C2–C6), documented great saphenous vein reflux >0.5 seconds, GSV diameter ≤12 mm, and ability to consent and attend follow-up are ideal candidates.
Not a fit: Patients with reflux outside the GSV, prior deep or superficial vein thrombosis, deep venous reflux, pelvic venous insufficiency, current anticoagulant use, or need for pharmacologic prophylaxis are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could lower recurrence at the sapheno-femoral junction and reduce postoperative pain or endovenous heat-induced thrombosis after EVLT.
How similar studies have performed: Endovenous laser treatment is an established alternative to open surgery, but direct comparisons of flush laser crossectomy at 1470 nm versus 1940 nm are limited and this specific comparison is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Primary VVs of Clinical Etiology Anatomy Pathophysiology (CEAP) clinical class of C2-C6 * Reflux along the GSV trunk lasting \>0.5 sec. * GSV trunk diameter ≤12 mm * Informed consent to participate in the study Exclusion Criteria: * Primary reflux outside the GSV trunk (including combined reflux) * History of deep or superficial vein thrombosis * Deep vein reflux * Non-thrombotic or post-thrombotic venous obstruction * Pelvic venous insufficiency * Use of oral anticoagulants * Indication for pharmacological prophylaxis after EVLT * Inability to use radial fiber of 1.4-1.57 mm at the surgeon's discretion * Refusal to participate in the study
Where this trial is running
Moscow
- MedSwiss Private Cinic — Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Kirill Lobastov, PhD — Pirogov Russian National Research Medical University
- Study coordinator: Kirill Lobastov, PhD
- Email: lobastov_kv@hotmail.com
- Phone: +79852116331
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.