773-6 Initial Human Implants with a Flexible Radio-Opaque Tantalum Stent

To address limitations of current stent technology a radio-opaque, tantalum stent using a novel continuous zig zag helical coil has been developed, undergone successful animal investigations prompting initial human implants. The target lesions were restenotic in a large (g3 mm reference diameter) vessel in single vessel disease. Between February 8 and June 22. 22/23 (96%) patients underwent successful single stent implantation. The patients were mostly male (17) mean age 61 yrs with single restenosis in 16 and multiple restenoses in 7. The target vessel was the LAD in 11. RCA in 10 and circumflex in 2. Stent visibility was graded as excellent in 18 and good in 5. Initial stent sizing was 3.0 in 15, 3.5 in 8 with a mean max inflation pressure of 12.8 ATM. There was a single delivery failure with stent embolization and subsequent percutaneous retrieval. There was one in-hospital Q wave infarct due to nonocclusive thrombus on day 2. There were no other major complications. Three patients had vascular complication (2 pseudoaneurysm, 1 bleed requiring transfusion). There were no out of hospital subacute thromboses; exercise treadmill at 6 weeks was negative in all patients. Pre PTCA Post PTCA Post Stent MLD mm 0.60 ± 0.07 * 1.57 ± 15 * 296 ± 0.21 % Stenosis 80.6 ± 2.3 * 33.3 ± 37 * –0.63 ± 1.98 * p l 0.001 Conclusion Preliminary human implants confirm the favourable design and delivery system with the distinct advantage of access to and preservation of side branches, delivery with a high pressure balloon and low profile delivery system. Long term randomized studies will be required to determine the future role of this stent.