TASC D II
Evaluation of the 4 French Pulsar-18 self-expanding nitinol stent in long femoropopliteal lesions (TASC D II) – 12-month results
- At 12 months, results of all 36 patients show primary patency (PP) rates of 85.4% and clinically-driven freedom from Target Lesion Revascularization (FTLR) rates of 87.5%.
- Clinical benefit and improvement of patients' quality of life measured by improvement in Rutherford Class of 1 or more in 97.1% of patients at 12 months; ankle-brachial index (ABI) improved from 0.60 ± 0.10 before the intervention to 0.88 ± 0.08 at 12 months; and pain-free walking distance improved from 56.1 ± 34.9 m before the intervention to 654.2 ± 419.1 m at 12 months (p < 0.0001).
- This all-comers registry for long femoropopliteal lesions of a mean lesion length of 18.2 cm proved the Pulsar-18 stent's safe usage. Diabetes and renal insufficiency had no negative impact on rates of PP or TLR.
Patient Demographics and Lesion Characteristics
Prospective, multi-center, investigator-initiated registry to evaluate the outcome of the implantation of the Pulsar-18 stent in lesions >15 cm in the femoropopliteal arteries.
- Number of patients (n): 36
- Principal investigator: Dr. Michael Lichtenberg, Klinikum Arnsberg, Germany
- Primary endpoint: PP at 6 and 12 months, defined as a binary restenosis on duplex ultrasound (PSVR < 2.5) at the stented target lesion with no clinically-driven TLR (cd-TLR) within the stented segment
- Secondary clinical endpoints (selected): improvement in resting ABI, improvement in pain-free walking distance, improvement in Rutherford Class, difference in PP in diabetic and renal insufficieny patients, difference in PP of single vs. overlapping stents
Primary Patency and Clinical Improvement in Rutherford Class
Self-expanding StentOne-handed stent release for accurate stent deployment
Self-expanding StentTri-axial shaft for a stable delivery system during stent deployment
Lichtenberg M et al. Evaluation of the 4-French Pulsar-18 Self-expanding Nitinol Stent in Long Femoropopliteal Lesions. Clinical Medicine Insights: Cardiology. 2014; 8(S2): 37–42.
© BIOTRONIK AG
All rights reserved. Specifications are subject to modification, revision and improvement.