TY - JOUR
T1 - Clinical and angiographic safety and efficacy trial with a new coronary stent
T2 - The RESTOR study of the R Stent
AU - Den Heijer, Peter
AU - Rensing, Benno J.W.M.
AU - Foley, David P.
AU - Van Den Bos, Arjan A.
AU - Corbeij, Huub M.A.
AU - Quarles Van Ufford, Michael A.
AU - Te Riele, Johannes A.M.
AU - Rooset, Paul C.H.
AU - Serruys, Patrick W.
PY - 2004/8
Y1 - 2004/8
N2 - The RESTOR trial (R Stent Efficacy and Safety Trial by ORBUS) is an efficacy and safety evaluation of the R Stent for treatment of patients with a single de novo coronary lesion < 25 mm in length in a coronary artery of 2.75-4.0 mm diameter. This new stent utilizes a patented dual helix design for radial strength and flexibility. The aim of the study was to assess major adverse cardiac events (MACE) and angiographic outcome at 6 months after implantation. From May to December 2000 a total of 121 patients with symptomatic stable or unstable angina pectoris or documented silent ischemia and a signficant single, de novo coronary lesion (average reference vessel diameter 2.84 ± 0.54 mm, average lesion length 10.53 ± 3.70 mm) were included in two Dutch centers. All patients were treated with clopidogrel 75 mg/day for 1 month and with aspirin ≥ 100 mg/day. The angiographic success rate (< 30% diameter stenosis post procedure) was 98.3%. Procedural success (angiographic success without in-hospital MACE) was 95.9%. The 6-month MACE rate was 12.4%. 101 of the 121 patients had an angiographic allow-up at 6 months. Minimal lumen diameter pre/post procedure and at follow-up was 0.98 ± 0.37, 2.64 ± 0.38 and 1.85 ± 0.68 mm, respectively. The resulting binary restenosis rate in this population was 20.8%. The coronary R Stent is safe and effective as a primary device for the treatment of native coronary lesions in patients with stable or unstable angina pectoris, and well suitable as a platform for a drug eluting stent.
AB - The RESTOR trial (R Stent Efficacy and Safety Trial by ORBUS) is an efficacy and safety evaluation of the R Stent for treatment of patients with a single de novo coronary lesion < 25 mm in length in a coronary artery of 2.75-4.0 mm diameter. This new stent utilizes a patented dual helix design for radial strength and flexibility. The aim of the study was to assess major adverse cardiac events (MACE) and angiographic outcome at 6 months after implantation. From May to December 2000 a total of 121 patients with symptomatic stable or unstable angina pectoris or documented silent ischemia and a signficant single, de novo coronary lesion (average reference vessel diameter 2.84 ± 0.54 mm, average lesion length 10.53 ± 3.70 mm) were included in two Dutch centers. All patients were treated with clopidogrel 75 mg/day for 1 month and with aspirin ≥ 100 mg/day. The angiographic success rate (< 30% diameter stenosis post procedure) was 98.3%. Procedural success (angiographic success without in-hospital MACE) was 95.9%. The 6-month MACE rate was 12.4%. 101 of the 121 patients had an angiographic allow-up at 6 months. Minimal lumen diameter pre/post procedure and at follow-up was 0.98 ± 0.37, 2.64 ± 0.38 and 1.85 ± 0.68 mm, respectively. The resulting binary restenosis rate in this population was 20.8%. The coronary R Stent is safe and effective as a primary device for the treatment of native coronary lesions in patients with stable or unstable angina pectoris, and well suitable as a platform for a drug eluting stent.
UR - https://www.scopus.com/pages/publications/4143052636
M3 - Article
C2 - 15282413
AN - SCOPUS:4143052636
SN - 1042-3931
VL - 16
SP - 402
EP - 405
JO - Journal of Invasive Cardiology
JF - Journal of Invasive Cardiology
IS - 8
ER -
