Background: Why the RIVIERA Trial Matters
Before a medical device can gain widespread clinical adoption, it must demonstrate safety and efficacy in well-designed prospective studies. The RIVIERA trial (Registry to Investigate the efficacy and safety of the VenaBlock® VeIn SEaling system for VaRicose veins in SingApore) was a landmark study providing the first systematic, prospective evaluation of VenaBlock® in a real-world clinical setting.
Study Design
The RIVIERA trial enrolled 29 patients (39 limbs, 39 truncal veins) with symptomatic varicose veins classified as CEAP C2–C6. Patients underwent VenaBlock® treatment performed by experienced vascular surgeons. Follow-up assessments were conducted at:
- 2 weeks post-procedure
- 3 months post-procedure
- 6 months post-procedure
Each follow-up included duplex ultrasound assessment of venous occlusion and validated quality-of-life questionnaires.
Key Results at 6 Months
The trial reported high rates of complete venous occlusion at all time points, confirming VenaBlock®'s technical reliability. Importantly, the safety profile was excellent — no major adverse events were recorded, and patient-reported outcomes showed significant improvement in both symptom burden and quality of life.
Quality of Life Outcomes
Patients reported significant improvements in:
- Leg heaviness and pain scores
- Swelling and edema
- Aesthetic appearance
- Ability to perform daily activities
Significance for Clinical Practice
The RIVIERA trial, published in Phlebology, provided the first peer-reviewed evidence base for VenaBlock® in an Asian patient population, demonstrating that results are generalizable beyond European cohorts. It established the foundation for VenaBlock®'s adoption across Asia-Pacific vascular surgery centers.
Building on RIVIERA: Subsequent Evidence
Following the RIVIERA trial, larger multicenter studies further validated VenaBlock®'s long-term efficacy. Registry data now confirms a 93.75% 12-month closure rate (long-term follow-up data ongoing), establishing VenaBlock® as a durable, long-term vein closure solution.