Chronic Venous Insufficiency (CVI) and Post-thrombotic Syndrome (PTS)

CVI may occur after an episode of deep vein thrombosis: in this case, it is denominated “post-thrombotic syndrome” (PTS). A combination of reflux due to incompetence of the venous valves and venous hypertension due to thrombotic obstruction is thought to underlie the pathophysiology of post-thrombotic syndrome.

Pelvic congestion syndrome (PCS) is a medical condition that causes chronic pelvic pain. The condition is thought to be due to problems with the enlarged or incompetent veins in the pelvic area and it is considered a form of CVI.

The following investigator-initiated studies have been launched at the Department of Angiology and are sponsored by the University of Zurich:

• ARIVA phase III trial (NCT04128956): Aspirin Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With PTS. Aim of this multinational superiority trial is to show if a combination therapy of rivaroxaban plus Aspirin is more efficient (superiority testing) compared to rivaroxaban alone in the prevention of early venous stent thrombosis in patients suffering from post-thrombotic syndrome in the first 6 months following endovascular therapy. A total of 316 patients will be recruited at 7 centers in Switzerland, Germany, and Austria over 4 years. Sponsor: University of Zurich. Status: recruiting.
• Venous Stent Registry (NCT02433054). Obstruction and stenosis of the ilio-femoro-caval veins are difficult to treat by conservative measures only. In the last decade, venous stenting has become an accepted treatment for ilio-femoro-caval obstruction. There is little data on short and long term outcomes of Nitinol stent placement specifically designed for the venous system accounting for the anatomy of the iliofemoral veins. The aim of the study is to study patency rates and clinical outcome data of specifically designed CE-marked stents for iliofemoral and inferior vena cava residual thrombosis, obstruction or stenosis. Sponsor: University of Zurich. Status: follow-up.
• Pelvic Congestion Syndrome study (2020-01838). This study focuses on the clinical presentation, diagnostic and treatment patterns of patients with pelvic congestion syndrome. Sponsor: University of Zurich. Status: ongoing.

The Department of Angiology is involved in the design and conduction of the following multinational studies:

• TOPOS registry (NCT02942394): Treatment of the Postthrombotic Syndrome With the Oblique Stent. Registry on the use of Obliquus stent in patients with deep vein thrombosis or post-thrombotic syndrome and concomitant common iliac vein compression (2016-02015). Sponsor: Optimed. Status: in follow up.
• BYV–PMCF: Prospective, multicentre single-arm Post-Market Clinical Follow-up (PMCF) study to evaluate safety and performance of the BeYond Venous Self-Expanding Stent. This study is conducted to evaluate safety and performance of the BeYond Venous Self-Expanding Stent for endovascular treatment of patients with symptomatic obstructions of the femoral or iliac vein. The study is a post-market clinical follow-up observational study with a CE marked medical device to evaluate technical success of the stenting and to collect long-term data about clinical performance as well as potential unknown side effects. Sponsor: Bentley InnoMed GmbH. Status: approval pending.
• Blueflow Venous Stent (DRKS00014827): Post Market Clinical Follow-up, retrospective and prospective, observational study of the IP Medical Vein Stent. The objective of the IP-Medical Vein Stent PMCF-study is to determine the patency rates and clinical outcome of the CE-marked IP-Medical Vein Stent “blueflow Venous Stent” for iliofemoral residual thrombosis, obstruction or stenosis. Sponsor: IP Medical GmbH. Status: recruitment completed.