Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the non-inferior, clinical outcomes after cyanoacrylate closure comparing the surgical stripping for incompetent saphenous veins.

Detailed Description
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Varicose veins are highly prevalent. In western countries, an estimated 23% of adults have varicose veins, and 6% have more advanced chronic venous disease, including skin changes and healed or active venous ulcers. There are several modalities to treat varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein, combined with excision of large varicosities, has been the standard of care for many years. Endovenous thermal ablation by radiofrequency ablation (RFA) or endovenous laser ablation (EVLA) has been shown to be a safe and effective alternatives with high long-term target vein closure rates. Although both techniques have gained broad acceptance in many countries, one major disadvantage of these techniques is the requirement for use of tumescent anesthesia to avoid the thermal injury of the surrounding structures. Cyanoacrylate closure for varicose veins has recently been introduced for treatment of the incompetent saphenous vein.

Official Title
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Randomized Controlled Trial Comparing the Clinical Outcomes After Cyanoacrylate Closure and Surgical Stripping for Incompetent Saphenous Veins

Conditions
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Occlusions Vein, Chronic Venous Insufficiency

Intervention / Treatment
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* Procedure: Cyanoacrylate closure
* Procedure: Surgical stripping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 80 years of age at the time of enrollment Reflux in great saphenous vein greater than 0.5 seconds after distal compression and release or Valsalva's maneuver in the standing or reverse Trendelenburg position Diameter of saphenous vein between 2mm to 20mm (with standing position) One or more of the following symptoms related to the incompetent saphenous vein: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling Clinical, Etiologic, Anatomic, and Pathophysiologic classification of C2 through C5 Exclusion Criteria: Previous treatment in targeted vein segment Tortuous vein in which the delivery catheter cannot be inserted Aneurysm of target vein segment >20 mm Daily use of narcotic or nonsteroidal anti-inflammatory pain medications to control pain associated with greater saphenous vein reflux Known hypercoagulable disorder Active malignancy Regular use of systemic anticoagulation Current use of systemic anticoagulant Previous deep vein thrombosis/pulmonary embolism or active acute superficial thrombophlebitis Unable to comply with the schedule and protocol evaluations Unable to ambulate Currently pregnant or breast feeding Known sensitivity to cyanoacrylate adhesives Symptomatic peripheral arterial disease with ankle-brachial index <0.9 Participation in another clinical study that has not reached primary endpoint within 30 days prior to enrollment Any condition which in the opinion of the investigator could compromise subject safety or adherence to the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, prospective randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cyanoacrylate closure<br>After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure for treatment of incompetent Saphenous Veins is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed. | Procedure: Cyanoacrylate closure<br>* After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.<br>* Other names: Cyanoacrylate closure for incompetent Saphenous vein;Procedure: Surgical stripping<br>* All types of anesthesia (general, spinal, regional block, or local anesthesia) can be used. The surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries. The saphenous vein is then removed using a stripper.<br>* Other names: Surgical stripping for incompetent Saphenous vein;|
| Active Comparator: Surgical stripping<br>For treatment of incompetent Saphenous Veins, surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries under all types of anesthesia (general, spinal, regional block, or local anesthesia). The saphenous vein is then removed using a stripper. Compression stocking is apply. | Procedure: Cyanoacrylate closure<br>* After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.<br>* Other names: Cyanoacrylate closure for incompetent Saphenous vein;Procedure: Surgical stripping<br>* All types of anesthesia (general, spinal, regional block, or local anesthesia) can be used. The surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries. The saphenous vein is then removed using a stripper.<br>* Other names: Surgical stripping for incompetent Saphenous vein;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure rate of the target vein/ Absence of refluxing vein | The primary endpoint of the study is to evaluate the complete closure of the target vein where complete closure is defined as Doppler ultrasound showing vein closure along entire treated vein segment with no discrete segments of patency exceeding 5cm after cyanoacrylate closure and absence of refluxing vein or residual vein after surgical stripping as read by a qualified site technologist or investigator. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative pain with visual analog scale | The subject will be asked to rate pain on a 0-10 numeric rating scale. (minimum-0 (best), maximum-10 (worst)) | 3 days | 
| Ecchymosis | The investigator will score the subjects ipsilateral leg of the occurrence of ecchymosis along treated segment, rated on a 0- to 5-point graded scale (0, none; 1, involving <25% of the treatment area; 2, 25%-50%; 3, 50%-75%; 4, 75%-100%; 5, extension above or below the treatment segment) | 3 days | 
| Venous Clinical Severity Score | Severity score on a 0-30 numeric rating scale ((minimum-0 (best), maximum-30 (worst)) | 1, 3, 6, 12 and 24 months after treatment | 
| Acceptability of Quality of life score | The quality of life scores are measured by the Aberdeen Varicose Vein Questionnaire (AVVQ) and EuroQOL five dimensions questionnaire (EQ-5D). The AVVQs are scored using a questionnaire. The total score for the 13 questions ranges from 0 to 100 points, with 0 points indicating the best possible quality of life. The EuroQOL is an instrument which evaluates the generic quality of life. The EuroQOL descriptive system is a preference-based measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status). | 1, 3, 6, 12 and 24 months after treatment | 
| Satisfaction of the patients: satisfaction rate | The subject will be asked to the satisfaction rate by five response categories (strongly agree, agree, uncertain, disagree, strongly disagree) after asking as following: I'm very satisfied with the medical care I receive. | 1, 3, 6, 12 and 24 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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varicose vein, stripping, endovenous, ablation, Occlusion, quality of life