Randomized controlled trial comparing the clinical outcomes after cyanoacrylate closure with VenaSeal™ Closure System and surgical stripping for incompetent saphenous veins

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0003203

Enrollment

146

Registered

2018-09-20

Start date

2018-10-01

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : - Cyanoacrylate closure with VenaSeal™ Closure System After successful access of target vein and insertion of guidewire under local anesthesia, a 5F introducer sheath/catheter is ad

Eligibility

Sex/Gender

All

Inclusion criteria

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 - CEAP classification of C2 through C5

Exclusion criteria

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 GSV 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

Design outcomes

Primary

Measure	Time frame
Closure rate of the target vein	—

Secondary

Measure	Time frame
Perioperative pain;Ecchymosis;Venous Clinical Severity Score;Quality of life score;Satisfaction of the patients;Serious Adverse Events	—

Countries

Korea, Republic of

Contacts

Public ContactJin Hyun Joh

Kyung Hee University Hosipital at Gangdong

joedoc@naver.com+82-2-440-6261

Outcome results