Registry of the treatment of dilated veins with the Clarivein catheter. Theprocedure, ClariVein, involved a rotating catheter (a small tube insertedinto the vein) and a drug that collapses the vei

Phase 1

• Conditions: varicose veins of the infragenual great saphenous vein, large supragenual great saphenous vein (>= 12 mm) and antero-lateral branch varicose veins; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2014-003341-10-NL
• Lead Sponsor: Rijnstate

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-19
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.Symptomatic varicose veins, C2-C5
2.Ultrasound criteria:
a.Diameter supragenual great saphenous vein (GSV) >/= 12 mm , not tortuouss; or
b.Insufficient antero-lateral branch; or
c.Insufficient below knee GSV
3.Signed informed consent
4.Patient consents to follow-up
5.Age > 18 year en < 80 year

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1.Patient is not capable to provide informed consent
2.Pregnancy and lactation
3.C6 varicose veins
4.Previous surgery or endovenous ablation at to treated segment
5.Deep venous vein thrombosis in medical history
6.Oral anti-coagulant therapy
7.Contra-indications or allergy for sclerosant
8.Immobilisation
9.Coagulant disorders or increaased risk for thrombo-embolic complications: known coagulant disorders such as hemofilia A, hemofilia B, Von Willebrand disease, Glanzmann disease, factor VII-deficiency, idiopathic thrombo-cytopenic purpura, factor V Leiden disease and deep venous thrombosis or lung emboli in medical history
10.Fontaine III of IV peripheral arterial disease
11.Severe kidney disease: known GFR < 30 ml/min.
12. Liver diseases accompanied by changes in coagulation of the blood, anamnistic indications for tendency towards haemorrhage , such as epistaxis and spontanuous hematoma, known liver cirrhosis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To provide insight in the safety and efficay of treatment with the ClariVein device for primary insufficiency of the great saphenous vein (GSV) supragenual (>= 12 mm), insuffucient infragenual GSV, and antero-lateral branch insufficiency.;Secondary Objective: per-operative pain measured with the VAS score. Post-operative pain during the first two weeks. Disease specific and general healt questionnaires. Time to resume daily activities and work. Intervention duration.;Primary end point(s): -Anatomical success (occlusion rate, evaluated using ultrasound scan) <br>-Clinical success (CEAP, VCSS)<br>-Peroperative pain (VAS-score)<br>-Postoperative pain during two weeks post-treatment (VAS-score,used pain medication)<br>;Timepoint(s) of evaluation of this end point: peroperative and first two weeks post-treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Postoperative complications<br>-Disease specific and general health status (AVVQ, RAND-SF36)<br>-Time to return to normal daily activities and work<br>-Duration of the intervention using MOCA<br>;Timepoint(s) of evaluation of this end point: Patients will be clinically evaluated and asked to fill out the Aberdeen Varicose Vein Questionnaire and the RAND 36 short form questionnaire pre-treatment, 4 weeks and 1 year after treatment.