To evaluate the outcome of the implantation of the Pulsar-18 stent followed by Passeo-18 Lux drug-coated balloon in the femoropopliteal arteries
- At 12 months, results from 51 patients show primary patency (PP) rates of 92.2% and freedom from clinically-driven Target Lesion Revascularization (cd-TLR) of 94.1%.
- At 12 months, freedom from major adverse events (MAE) is 98.1%, confirming the safety of the treatment combination with Pulsar-18 and Passeo-18 Lux.
- Significant improvement in Rutherford Class (RC) at 6 months and sustained over time shows clinical benefit and improvement of patients' quality of life.
- The combined approach of Passeo-18 Lux peripheral drug-coated balloon (DCB) and Pulsar-18 self-expanding stent is feasible and promising, and a potential future treatment option in complex, TASC C/D lesions.
Key Baseline Demographics
Prospective, multi-center, investigator-initiated registry to evaluate the implantation outcome of the Pulsar-18 stent followed by Passeo-18 Lux DCB in the femoropopliteal arteries.
- Number of patients (n): 65 (12-month data available on n 51)
- Principal investigator: Dr. Patrice Mwipatayi Royal Perth Hospital, University of Western Australia, Perth, Australia
- Primary endpoint: PP at 12 and 24 months, defined as a binary duplex ultrasound ratio PSVR <2.5 at the stented target lesion with no clinically-driven reintervention within the stented segment.
- Secondary clinical endpoints (selected): secondary patency at 12 and 24 months, freedom from MAE at 12 and 24 months, freedom from stent fracture, freedom from TLR, freedom from major limb amputation and death.
Self-expanding StentOne-handed stent release for accurate stent deployment
Drug-Coated BalloonClinically proven to reduce restenosis and the need for reinterventions
Source: Dr. Mwipatayi P. Presented at LINC 2015.© BIOTRONIK AGAll rights reserved. Specifications are subject to modification, revision and improvement.