Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore

Varicose Veins Clinical Trial

— RIVIERA  

Official title:

Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04339075
• Other study ID #: 2019/2749
• Status: Active, not recruiting
• Start date: October 1, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2020
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the efficacy of the Venablock©Vein Sealing System (VBVS) for the treatment of lower extremity superficial truncal veins in a real-world clinical setting in a multi-racial Asian population in Singapore.

Description:

The purpose of the Registry to Investigate the Efficacy and Safety of Venablock©Vein Sealing System for Varicose Veins in Singapore (RIVERIA), is to investigate the performance of cyanoacrylate glue closure (CAC) using this device, in which multiple incompetent superficial saphenous truncal veins (great saphenous (GSV), short saphenous vein (SSV), anterior accessory saphenous vein (AASV) will be treated at the same setting, and compression stockings will not be used post-operatively. The inclusion criteria for this study will be liberalized, and veins up to 12mm in diameter will be treated. As such,RIVIERA will be the first prospective trial conducted in Asia on a predominantly Asian cohort of patients to report on the performance of Venablock© for blocking incompetent truncal veins. This study specifically focuses on the initial technical outcomes, safety, anatomical occlusion, and patient experience after treatment with Venablock© with broader inclusion of patients than previous caucasian based trials.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age > 21 years old and ability to understand the requirements of the study and to provide informed consent

2. C2-C6 varicose veins/CVI (CEAP Class 1 patients will be excluded)

3. Symptomatic primary GSV,SSV or AASV incompetence, with reflux > 0.5 seconds on colour Duplex, including one or more of the following symptoms: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling

4. Patients who had GSV, SSV or AASV diameters of 3mm to 12mm in the standing position

Exclusion Criteria:

1. Current DVT or history of DVT

2. Pregnant patients

3. Arterial disease (ABPI<0.8)

4. Sepsis

5. Patient who are unwilling to participate

6. Inability or unwillingness to complete the time-point questionnaires

7. Adverse reaction to sclerosant or cyanoacrylate previously

8. Multiple drug allergies

9. Previous intervention with the VenaSeal cyanoacrylate glue closure system

10. Severely tortuous GSV, SSV or AASV

11. Life expectancy < 1 year

12. Active treatment for malignancy other than non-melanoma skin cancer

13. Current, regular use of systemic anticoagulation (e.g., warfarin, heparin)

14. Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Varicose Veins
• Venous Insufficiency
• Venous Reflux

Intervention

Other:
• Questionnaires
Questionnaires to access the quality of life (EQ5D, VCSS, CVVQ, CIVIQ, Patient satisfaction survey)

Locations

Country	Name	City	State
Singapore	Singapre General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (15)

Brothers MF, Kaufmann JC, Fox AJ, Deveikis JP. n-Butyl 2-cyanoacrylate--substitute for IBCA in interventional neuroradiology: histopathologic and polymerization time studies. AJNR Am J Neuroradiol. 1989 Jul-Aug;10(4):777-86. — View Citation

Darwood RJ, Theivacumar N, Dellagrammaticas D, Mavor AI, Gough MJ. Randomized clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins. Br J Surg. 2008 Mar;95(3):294-301. doi: 10.1002/bjs.6101. — View Citation

Lee Q, Gibson K, Chan SL, Rathnaweera HP, Chong TT, Tang TY. A comparison between Caucasian and Asian superficial venous anatomy and reflux patterns - Implications for potential precision endovenous ablation therapy. Phlebology. 2020 Feb;35(1):39-45. doi: 10.1177/0268355519845984. Epub 2019 Apr 29. — View Citation

Marsden G, Perry M, Kelley K, Davies AH; Guideline Development Group. Diagnosis and management of varicose veins in the legs: summary of NICE guidance. BMJ. 2013 Jul 24;347:f4279. doi: 10.1136/bmj.f4279. — View Citation

Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31. — View Citation

Nesbitt C, Bedenis R, Bhattacharya V, Stansby G. Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus open surgery for great saphenous vein varices. Cochrane Database Syst Rev. 2014 Jul 30;(7):CD005624. doi: 10.1002/14651858.CD005624.pub3. Review. — View Citation

Ovali C, Sevin MB. Twelve-month efficacy and complications of cyanoacrylate embolization compared with radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2019 Mar;7(2):210-216. doi: 10.1016/j.jvsv.2018.10.019. Epub 2019 Jan 14. — View Citation

Rabe E, Otto J, Schliephake D, Pannier F. Efficacy and safety of great saphenous vein sclerotherapy using standardised polidocanol foam (ESAF): a randomised controlled multicentre clinical trial. Eur J Vasc Endovasc Surg. 2008 Feb;35(2):238-45. Epub 2007 Nov 7. — View Citation

Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg. 2011 Aug;98(8):1079-87. doi: 10.1002/bjs.7555. — View Citation

Shepherd AC, Gohel MS, Brown LC, Metcalfe MJ, Hamish M, Davies AH. Randomized clinical trial of VNUS ClosureFAST radiofrequency ablation versus laser for varicose veins. Br J Surg. 2010 Jun;97(6):810-8. doi: 10.1002/bjs.7091. — View Citation

Shepherd AC, Gohel MS, Lim CS, Hamish M, Davies AH. Pain following 980-nm endovenous laser ablation and segmental radiofrequency ablation for varicose veins: a prospective observational study. Vasc Endovascular Surg. 2010 Apr;44(3):212-6. doi: 10.1177/1538574409359337. Epub 2010 Feb 11. — View Citation

Siribumrungwong B, Noorit P, Wilasrusmee C, Attia J, Thakkinstian A. A systematic review and meta-analysis of randomised controlled trials comparing endovenous ablation and surgical intervention in patients with varicose vein. Eur J Vasc Endovasc Surg. 2012 Aug;44(2):214-23. doi: 10.1016/j.ejvs.2012.05.017. Epub 2012 Jun 15. Review. — View Citation

Tang TY, Kam JW, Gaunt ME. ClariVein® - Early results from a large single-centre series of mechanochemical endovenous ablation for varicose veins. Phlebology. 2017 Feb;32(1):6-12. doi: 10.1177/0268355516630154. Epub 2016 Jul 9. — View Citation

Vanlangenhove P, De Keukeleire K, Everaert K, Van Maele G, Defreyne L. Efficacy and safety of two different n-butyl-2-cyanoacrylates for the embolization of varicoceles: a prospective, randomized, blinded study. Cardiovasc Intervent Radiol. 2012 Jun;35(3):598-606. doi: 10.1007/s00270-011-0188-9. Epub 2011 Jun 3. — View Citation

Yavuz T, Acar AN, Aydin H, Ekingen E. A retrospective study of a new n-butyl-2-cyanoacrylate glue ablation catheter incorporated with application guiding light for the treatment of venous insufficiency: Twelve-month results. Vascular. 2018 Oct;26(5):547-555. doi: 10.1177/1708538118770548. Epub 2018 Apr 11. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occlusion of treated vein post-procedure		Immediately post-op
Primary	Change in anatomy of treated vessel	Anatomical Success as measured at each timepoint using ultrasound to ensure occlusion of treated vessel. Recurrence or treatment failure will be defined as a re-opening of a segment > 5cm in length.	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Quality of Life Score using the EQ-5D questionnaire	EQ5D is used to assess quality of life based on Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety, rated at 5 levels: no problems, slight problems, moderate problems, severe problems, unable to perform activity. Inputs from this questionnaire is used to observe for changes in quality of life overtime. The higher the score, the better the quality of life is.	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)	CIVIQ is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe). Based on inputs, Global Index Score (GIS) will be tabulated, ranging for 0 to 100 - the higher the value, the poorer the quality of life.	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)	To measure health status of varicose veins patients based on symptoms and impact on daily activities. A total score ranging from 0 to 100 will be tabulated, with 100 being worst quality of life.	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Clinical Change using Venous Clinical Severity Score (VCSS)	VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe).	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Pain Score	Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain)	First 10 days post-procedure
Secondary	Time taken to return to work and normal activities		Recorded 10 days post-procedure
Secondary	Occlusion rates	Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Patient satisfaction with treatment: survey	A short survey to assess patient satisfaction and if there are any observed improvement in terms of appearance and symptoms post-procedure. Options range from highly unsatisfied to highly satisfied.	2 weeks, 3 months, 6 months, 12 months post-procedure
Secondary	Cost effectiveness of the intervention	to evaluate the cost involved with the procedure performed	12 months post-procedure