Intact Vascular has announced the peer-reviewed publication of its Tack optimized balloon angioplasty (TOBA) III 12-month clinical trial results in the Journal of Vascular Surgery.
The multi-center, single-arm, prospective study investigated the combination of the Tack endovascular system with Medtronic’s IN.PACT Admiral drug-coated balloon as a treatment in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA).
The trial results were previously presented as part of the high impact clinical research session during the 2019 Transcatheter Cardiovascular Therapeutics (TCT) conference.
“We are thrilled to have the TOBA III data published in the Journal of Vascular Surgery,” commented Peter Schneider, co-founder and chief medical officer of Intact Vascular. “This peer-reviewed article adds to the strong body of evidence supporting use of the Tack endovascular system for focal dissection repair when treating lesions both above- and below-the-knee.”
The study was conducted in multiple sites across Europe and enrolled 201 patients, including 169 patients with arterial lesions ≤150mm in length and a subset of 32 patients with long arterial lesions (>150 and ≤250mm).
All patients suffered from peripheral arterial disease (PAD) and underwent drug-coated balloon angioplasty, consequently experiencing at least one dissection requiring repair.
Results from the 169-patient standard lesion cohort (≤150mm) impressively demonstrated a 95% primary K-M patency with 97.5% K-M freedom from clinically-driven reintervention at 12-months and a 0.6% bailout stent rate.
The observational data from the long lesion subset (>150 and ≤250mm) was analysed separately. Results from these 32 patients notably demonstrated 98.8% complete dissection resolution and 89.3% K-M vessel patency, with 96.8% K-M freedom from clinically-driven reintervention at 12-months and a 0% bailout stent rate.
“The TOBA III trial met all primary endpoints and impressively demonstrated the highest reported rates of safety, patency and freedom from clinically driven reintervention when treating above-the-knee lesions,” commented Marianne Brodmann, head of the Clinical Division of Angiology, Medical University of Graz, Austria and principal investigator of the TOBA III trial.
She added: “This study is unique in that we enrolled patients with 100% dissected vessels and included a long lesion subset, notoriously a complex cohort. These clinically compelling data further validate Tack implants as safe and effective for PAD interventions.”