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Percutaneous coronary interventions in patients with thrombo\u2010occlusive disease or friable degenerative saphenous vein grafts are associated with considerable periprocedural morbidity and mortality, predominantly related to microscopic distal embolization. X\u2010Sizer catheter system is a novel atherectomy and thrombectomy device that consists of a helix cutter connected to a handheld motor drive unit and a vacuum collection chamber for aspiration of excised atheroma, thrombus, and debris. Quantitative coronary angiography was obtained in 14 patients before and after X\u2010Sizer extraction atherectomy with adjunctive balloon angioplasty and stenting. Thirteen native coronary arteries and one saphenous vein graft were treated. Mean preprocedural reference vessel diameter was 3.06 \u00b1 0.66 mm. There were 71.4% AHA\/ACC type B2 and C lesions. Preprocedural thrombus was present in nine patients and total occlusion in 64% of cases. Minimal luminal diameter was increased from 0.29 \u00b1 0.47 mm to 1.32 \u00b1 0.64 mm, a gain of 1.04 \u00b1 0.69 mm after atherectomy. Final total gain was 1.47 \u00b1 0.61 mm. Mean diameter stenosis was reduced from 89.3% to a final residual stenosis of 14.4%. Postatherectomy distal embolization occurred in one patient who had heavy preprocedural thrombus burden. No episodes of perforation, distal coronary spasm, abrupt closure, or slow\/no\u2010reflow occurred. The angiographic analysis of the first cohort of human subjects suggests that X\u2010Sizer helical atherectomy is a feasible method of removing occlusive tissue or thrombus in coronary artery disease with a low angiographic complication rate. A large\u2010scale randomized phase II clinical trial is underway to determine the ultimate safety and efficacy of this device in thrombo\u2010occlusive native coronary arteries and saphenous vein grafts. Cathet Cardiovasc Intervent 2002;55:133\u2013139. \u00a9 2002 Wiley\u2010Liss, Inc.<\/jats:p>","DOI":"10.1002\/ccd.10036","type":"journal-article","created":{"date-parts":[[2002,9,11]],"date-time":"2002-09-11T01:43:16Z","timestamp":1031708596000},"page":"133-139","source":"Crossref","is-referenced-by-count":13,"title":["Angiographic outcome after intracoronary X\u2010Sizer helical atherectomy and thrombectomy: First use in humans"],"prefix":"10.1002","volume":"55","author":[{"given":"On\u2010Hing","family":"Kwok","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ross","family":"Prpic","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jorge","family":"Gaspar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Detlef 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