DEBAS Registry

To evaluate the outcome of the implantation of the Pulsar-18 stent followed by Passeo-18 Lux drug-coated balloon in the femoropopliteal arteries

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Conclusion

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

Study Design

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.