May 13, 2020
Twelve-Month Data Published From European TOBA III Study of Intact Vascular's Tack Endovascular System
May 13, 2020—Intact Vascular, Inc. announced that the 12-month results from the Tack Optimized Balloon Angioplasty (TOBA) III clinical trial were published by Marianne Brodmann, MD, et al in the Journal of Vascular Surgery. Prof. Brodmann, who serves as Principal Investigator of the TOBA III trial, is Head of the Clinical Division of Angiology, Medical University of Graz, Austria.
The multicenter, single-arm, prospective study investigated the combination of the company's Tack endovascular system with Medtronic’s In.Pact Admiral drug-coated balloon (DCB) to treat peripheral artery disease (PAD) in the superficial femoral artery and/or proximal popliteal artery.
The trial results were previously presented as part of the High Impact Clinical Research session during TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium held September 25–29, 2019 in San Francisco, California.
According to Intact Vascular, the TOBA III study was conducted in multiple sites across Europe. It enrolled 201 patients, including 169 patients with arterial lesions ≤ 150 mm in length and a subset of 32 patients with long arterial lesions (> 150 and ≤ 250 mm). All patients had PAD and underwent DCB angioplasty, consequently experiencing at least one dissection requiring repair.
Results from the 169-patient standard lesion cohort (≤ 150 mm) demonstrated a 95% primary Kaplan-Meier (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 ≤ 250 mm) was analyzed separately. Results from these 32 patients 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 Prof. Brodmann in Intact Vascular's announcement. “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.”