iVascular Announces Interim Data From BARISTA Trial of Restorer BMS

August 29, 2024—iVascular announced 12-month clinical outcomes from the BARISTA trial that highlight the efficacy and safety of the Restorer bare-metal stent (BMS) in treating aortoiliac lesions.

BARISTA is a prospective, multicenter, nonrandomized, single-arm observational study assessing the long-term (24 months) safety and efficacy of Restorer in TransAtlantic Inter-Society Consensus (TASC) A through D aortoiliac lesions.

The company noted that this interim analysis includes 12-month follow-up from the first 67 patients. These data were initially presented by Principal Investigator Lieven Maene, MD, at LINC 2024, the Leipzig Interventional Course held May 28-31, in Leipzig, Germany.

Of the lesions in this first cohort, 76.1% showed moderate to severe calcification and 86.6% included TASC A and B lesions.

As outlined by iVascular in the press release, the Restorer demonstrated efficacy at 12 months in terms of primary endpoint success and ankle-brachial index (ABI) improvement:

• Primary patency was achieved in 96.9% of patients, freedom from target lesion revascularization in 98.5%, and freedom from major amputation in 100%.
• ABI had a mean increase of 0.24 compared to baseline.

Dr. Maene noted in the press release that benefits of the Restorer include good trackability due to the low profiles (6 F for all diameters), as well as flexibility for reaching the lesion and achieving optimal wall apposition.

The company also announced that BARISTA has now successfully completed patient enrollment with 200 total participants.