Early Outcome of Mechanochemical Endovenous Ablation (ClariVein-2)

Mechanochemical Endovenous Ablation of Great Saphenous Vein Incompetence Using the ClariVeinTM Device: a Prospective Study

More than 25 percent of the general population suffers from varicose veins, which has a considerable impact on quality of life. Nowadays endovenous treatment modalities for great saphenous incompetence are widely accepted. Mechanochemical endovenous ablation is a new tumescent-less technique, that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. The current study aims at evaluating short and long term outcome after mechanochemical endovenous ablation.

Study Overview

• Status: Completed
• Conditions: Varicosis
• Intervention / Treatment: Device: ClariVein

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• Netherlands
  • Nieuwegein, Netherlands
    • St. Antonius Hospital
  • Gelderland
    • Arnhem, Gelderland, Netherlands
      • Rijnstate hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with insufficiency of the greater saphenous vein will be included.

Description

Inclusion Criteria:

• Insufficiency of the GSV
• Ultrasound criteria for endovenous treatment have been met:
• Diameter GSV between 3-12 mm
• No thrombus present at the GSV part to be treated
• Signed informed consent
• Patient willing to present at follow-up visits
• Age > 18 jaar

Exclusion Criteria:

• Patient is unable to give informed consent
• Patient unable to present at all follow-up visits
• Other treatment is more suitable for the treatment of the varicose veins than mechano-chemical ablation
• Pregnancy and breast feeding
• Known allergy/ contra indication for sclerotherapy
• Previous ipsilateral surgical treatment of varicose veins
• Deep venous vein thrombosis in medical history
• Anticoagulant therapy

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GSV insufficiency; Patients with insufficiency of the greater saphenous vein (GSV) will be included.	Device: ClariVein; Using the ClariVein device, the GSV will be occluded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occlusion rate	The percentage of GSV occluded	30 days, 1, 2, and 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health status	Using the RAND 36-Item Short Form Health Survey (SF-36)the general health status will be evaluated at the mentioned time points. The SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.	30 days, 1, 2, and 5 years
Disease related quality of life	Using the AVVQ (Aberdeen Varicose Vein questionnaire) the quality of life related to the disease will be evaluated at the mentioned time points.	30 days, 1, 2, and 5 years
Pain score during procedure	The pain will be scored during procedure using the VAS score.	peri-procedural
2-weeks post-procedure pain score	The pain will be scored daily for two weeks after the procedure using the VAS score.	two weeks
recovery time	The time (in days) after the procedure until patients were able to restart daily activity/daily work	two weeks
procedural complications	all complications related to the procedure will be evaluated at the mentioned time points.	during procedure
post-procedural complications	all complications related to the procedure will be evaluated at the mentioned time points.	1 year

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: St. Antonius Hospital
• Investigators: Principal Investigator: Michel MJ Reijnen, MD, PhD, Rijnstate hospital; Principal Investigator: Jean-Paul Vries, de, MD, Phd, St. Antonius Hospital

Publications and helpful links

General Publications

• van Eekeren RR, Boersma D, Elias S, Holewijn S, Werson DA, de Vries JP, Reijnen MM. Endovenous mechanochemical ablation of great saphenous vein incompetence using the ClariVein device: a safety study. J Endovasc Ther. 2011 Jun;18(3):328-34. doi: 10.1583/11-3394.1.
• van Eekeren RR, Boersma D, de Vries JP, Reijnen MM. [Endovenous mechanochemical ablation for varicose veins--a new endovenous technique without tumescent anaesthesia]. Ned Tijdschr Geneeskd. 2011;155(33):A3177. Dutch.
• van Eekeren RR, Boersma D, Konijn V, de Vries JP, Reijnen MM. Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins. J Vasc Surg. 2013 Feb;57(2):445-50. doi: 10.1016/j.jvs.2012.07.049. Epub 2012 Nov 8.
• Boersma D, van Eekeren RR, Werson DA, van der Waal RI, Reijnen MM, de Vries JP. Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein((R)) device: one-year results of a prospective series. Eur J Vasc Endovasc Surg. 2013 Mar;45(3):299-303. doi: 10.1016/j.ejvs.2012.12.004. Epub 2013 Jan 9.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: August 8, 2011
• First Submitted That Met QC Criteria: October 24, 2011
• First Posted (Estimate): October 25, 2011

Study Record Updates

• Last Update Posted (Actual): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: safety; efficacy; QOL; insufficiency; GSV; ClariVein device
• Other Study ID Numbers: NL26327.091.09