CASS (CyanoAcrylate closure versus Surgical Stripping for incompetent saphenous veins) study: a randomized controlled trial comparing clinical outcomes after cyanoacrylate closure and surgical stripping for the treatment of incompetent saphenous veins

Abstract

Background: Several modalities are used for the treatment of varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein has been the standard of care for many years. Endovenous thermal ablation has been shown to be a safe and effective alternative with high, long-term, target-vein closure rates. Despite this, there is the possibility of thermal injury to surrounding structures. The recently introduced cyanoacrylate closure is also considered to be a good alternative and the risk of injury to surrounding structures is minimal. The purpose of this study is to demonstrate the non-inferiority of cyanoacrylate closure with the VenaSeal™ closure system compared to surgical stripping in terms of clinical outcomes for the treatment of incompetent great saphenous veins. Methods/design: This is an open-label, multicenter, prospective, randomized controlled trial evaluating the noninferior clinical outcomes of cyanoacrylate closure compared to surgical stripping for the treatment of incompetent saphenous veins. After baseline measurements, participants will be randomly allocated into either the cyanoacrylate closure group or the surgical-stripping group. The primary endpoint of the study is the complete closure rate of the target vein in the cyanoacrylate closure group, and the absence of venous reflux or residual venous tissue after surgical stripping in the surgical-stripping group. These endpoints will be measured by Doppler ultrasound

A multicenter randomized controlled trial of cyanoacrylate closure and surgical stripping for incompetent great saphenous veins

“…The CASS (cyanoacrylate closure vs surgical stripping) trial for the treatment of incompetent GSVs was an open-label, multicenter, prospective, randomized controlled trial conducted at seven medical centers in Korea. 11 All the investigators participating in the CASS study were experienced with both CAC and SS. The ethics committee of each participating institution approved the present study, and each patient provided written informed consent.…”

“…Details of the inclusion and exclusion criteria were provided in a previous report. 11 The major exclusion criterion was the presence of a tortuous vein in which the delivery catheter could not be inserted before treatment of the target vein with CAC. Large saphenous veins >20 mm in diameter were also excluded.…”

Complex Hypersensitivity and Irritation Reaction (CHAIR) Phenomenon after Cyanoacrylate Closure of Varicose Vein

“…One major NTNT technique involves the use of cyanoacrylate glue (CAG) to induce occlusion and fibrosis of the saphenous trunk. The first CAG developed for this purpose was VenaSeal (Medtronic), which has been most commonly used in clinical trials originating in the United States [ 3 ], Western Europe [ 4 ], and Korea [ 5 ].…”

“…The trial investigating CAC vs. surgical stripping (CASS) trial for incompetent saphenous veins was the first prospective randomized controlled study to compare the clinical outcomes of nonthermal ablation with those of CAG and surgical stripping [ 5 ]. This trial demonstrated that both CAC and surgical stripping achieved complete occlusion of the target vein (TV) at 3 months.…”