Philips’ Duo Venous Stent System Studied in VIVID Trial at 24 Months

November 3, 2024—The 24-month outcomes from the VIVID clinical trial, which evaluated the safety and efficacy of the Duo venous stent system (Royal Philips) for the treatment of patients with nonmalignant iliofemoral occlusive disease, have been presented.

VIVID was a prospective, multicenter, single-arm study conducted in the United States and Poland. Study centers enrolled patients with nonthrombotic, acute thrombotic, or chronic postthrombotic clinically significant venous outflow obstruction.

Mahmood Razavi, MD, presented the 24-month data in the late-breaking clinical trials session at The VEINS, the Venous Endovascular Interventional Strategies annual venous education symposium held by The VIVA Foundation on November 2-3 in Las Vegas, Nevada.

As summarized in the press release from The VEINS, the primary safety endpoint was freedom from major adverse events at 30 days postindex procedure. The primary efficacy endpoint was primary patency of the stented segment at 12 months. The 12-month primary endpoints were met and presented previously.

The press release advised that the secondary and observational endpoints collected through 24 and 36 months included primary patency, primary assisted patency, secondary patency, clinically driven target lesion revascularization (CD-TLR), clinically driven target vessel revascularization (CD-TVR), major adverse events, and patient-reported outcomes.

The 24-month results reported at The VEINS included the following:

• Primary patency was 89.9%.
• The Kaplan-Meier estimates of freedom from CD-TLR and CD-TVR were 94.1% and 93.4%, respectively.
• Primary assisted patency and secondary patency were 95.7% and 96.5%, respectively.
• The Kaplan-Meier estimate of freedom from major adverse events was 92.7%.
• No stent fractures, migrations, or embolizations were reported.

These data confirm the safety and efficacy of the Duo venous stent system in treating patients with nonthrombotic, acute thrombotic, or chronic post-thrombotic venous outflow obstruction, concluded the study in The VEINS press release.