Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomised Trial of Radiofrequency Ablation vs Conventional Surgery for Superficial Venous Insufficiency: if You Don't Tell, They Won't Know
Brief Summary: The current study was a double blind randomised controlled trial that compared radiofrequency ablation (RFA) versus conventional surgery (CS) in patients who served as their own controls and who had intact great saphenous veins (GSVs).


Options:
A: Inclusion Criteria:

1. Age ≥ 21 years and ≤ 70 years of age at the time of screening
2. Reflux in the great saphenous vein (GSV) greater than 0.5 sec reflux
3. One or more of the following symptoms related to the target vein: aching, throbbing, heaviness, fatigue, pruritis, night cramps, restlessness, generalized pain or discomfort, swelling
4. GSV diameter while standing of 3-12 mm throughout the target vein as measured by Duplex ultrasound
5. Clinical, etiology, assessment and pathophysiology (CEAP) classification of C2 (if symptomatic) - C4b
6. Ability to walk unassisted
7. Ability to attend follow-up visits
8. Ability to understand the requirements of the study and to provide informed consent

Exclusion Criteria:

1. Life expectancy \< 1 year
2. Active treatment for malignancy other than non-melanoma skin cancer
3. Symptomatic peripheral arterial disease with ankle-brachial index (ABI) \<0.89
4. Daily use of narcotic or non-steroidal anti-inflammatory pain medications to control pain associated with GSV reflux
5. Current, regular use of systemic anticoagulation (e.g., warfarin, heparin)
6. Previous or suspected deep vein thrombosis (DVT) or pulmonary embolus (PE)
7. Previous superficial thrombophlebitis in GSV
8. Previous treatment of venous disease in target limb, other than spider vein treatment
9. Known hypercoagulable disorder
10. Conditions which prevent vein treatment with either RFA or VenaSeal SCS
11. Immobilization or inability to ambulate
12. Pregnant prior to enrollment
13. Tortuous GSV, which, in the opinion of the investigator, will limit catheter placement or require more than one primary access site
14. Aneurysm of the target vein with local diameter \>12 mm
15. Significant, incompetent, ipsilateral small saphenous, intersaphenous or anterior accessory great saphenous vein(s)
16. Known sensitivity to cyanoacrylate (CA) adhesives
17. Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment
18. Patients who require bilateral treatment during the next 3 months
19. Patients who require additional ipsilateral treatments on the same leg within 3 months following treatment
B: Inclusion Criteria:

* clinical classification of venous disease C2-C4
* ultrasound-verified reflux in the GSV
* mean GSV diameter in the thigh between 5 and 12 millimetres
* informed consent.

Exclusion Criteria:

* body mass index (BMI) of over 40
* peripheral arterial disease
* lymphoedema
* pregnancy
* allergy to either the sclerosant or lidocaine
* severe general illness
* malignancy
* previous deep venous thrombosis
* previous varicose vein intervention in the same leg
* coagulation disorders
C: Inclusion Criteria:

* incompetence of great saphenous vein for minimal 20 cm
* life expectancy at least 3 years
* open and competent deep venous system
* willing to undergo both treatments

Exclusion Criteria:

* active ulcer
* signs of deep venous thrombosis with duplex
* incompetence of the deep venous system
D: Inclusion Criteria:

* Age between 18 and 60 years
* Clinical, etiologic, anatomic, pathophysiologic (CEAP): clinical grades 2 to 5 (C2-5), primary (Ep), superficial (As) and reflux only (Pr)
* Duplex scan confirmed primary bilateral GSV insufficiency requiring surgery (insufficiency with reverse venous flow was regarded significant if persisting more than 0.5 seconds in a standing position)
* Duplex scan confirmed suitability for RFA (see exclusion criteria)
* Patients able to give informed consent

Exclusion Criteria:

* Varicose veins without GSV insufficiency on duplex scan
* Previous varicose vein surgery
* Associated small saphenous vein reflux, duplication of the GSV at the SFJ, deep venous insufficiency or previous DVT on duplex scan
* GSV diameter \<3 mm or \>12 mm in the supine position
* Thrombus in the GSV
* Patients with a pacemaker or internal defibrillator
* Concomitant peripheral arterial disease (ankle-brachial pressure index of \<0.9)
* Patients on oral anticoagulants
* Patients with high blood pressure not controlled by medication
* Patients with known thrombophilia, cancer or lupus
* Pregnancy

Answer: D