Zero Incidence of Late Stent Thrombosis Reported in CUSTOM I, II, and III
WASHINGTON and MENLO PARK, Calif., Oct. 13 /PRNewswire-FirstCall/ -- XTENT, Inc. (Nasdaq: XTNT) today announced positive long-term follow-up data from the CUSTOM I, II and III clinical trials that reinforces the efficacy of the Custom NX(R) drug eluting stent (DES) system in treating patients with coronary artery disease. The CUSTOM clinical trials are prospective studies designed to investigate the safety and efficacy of the Custom NX DES system. The three trials have enrolled 220 patients and represent one of the most challenging patient populations -- those with long and/or multiple lesions -- ever studied in DES trials.
"We are pleased to see favorable outcome trend data continue with the CUSTOM Trials even as we look out as far as two and three years of follow-up in very complex patients," commented Pieter R. Stella, MD, Director, Cardiovascular Research, University Medical Centre Utrecht, The Netherlands, and one of the CUSTOM clinical trial investigators, who presented the data during a DES panel at the Cardiovascular Research Foundation's (CRF) twentieth annual Transcatheter Cardiovascular Therapeutics (TCT) meeting. "To date, the incidence of late stent thrombosis in all three CUSTOM trials is zero percent and this is particularly encouraging."
The results presented today include three-year follow-up data from 30
patients studied in CUSTOM I, two-year data from the 100 patients in CUSTOM
II and one-year data in 90 patients enrolled in CUSTOM III. Patients
enrolled in these trials presented with the smallest reference vessel
diameter (RVD) ever in a DES study, and CUSTOM II featured the longest
|SOURCE XTENT, Inc.|
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