pervideo i registry, the lutonix paclitaxel-coated balloon catheter for the treatment of coronary in-stent restenosis

Conditions: In-Stent Restenosis

Summary: the study will enroll patients with angiographic evidence of in-stent restenosis of a previously placed bare-metal stent. subjects will be treated with a lutonix catheter. the purpose is to investigate the feasibility, safety, and efficacy of the lutonix catheter in the native coronary system. angiographic and clinical outcomes will be assessed.


Eligibility criteria:
inclusion criteria: * male or non-pregnant/non-breast feeding female ≥18 years of age. women of childbearing potential must have a negative pregnancy test within 7 days of the procedure; * documented stable angina pectoris canadian cardiovascular society classification (ccsc) 1-4, unstable angina pectoris with documented ischemia (braunwald i-ii) or documented silent ischemia; * previous history of native coronary bare metal stenting ≥60 days; * lvef ≥25%; * patient is an acceptable candidate for ptca, stenting, and emergent cabg; * patient is willing to provide informed consent and comply with follow-up visits and testing schedule; * target lesion is in a native coronary with previous single bare metal stent; stenosis is ≥50% and \<100% by visual estimate or qca prior to defined pre-dilatation; * reference vessel diameter (rvd) is ≥2.5 and ≤3.25; * target lesion is ≤40 mm in length and can be treated in its entirety by no more than 2 contiguous lutonix catheters; * guidewire is able to cross lesion(s) and be placed in distal vessel prior to enrollment; * enrollment permitted after successful treatment of 1 to 2 non-study lesions in a single other non-study vessel. successful treatment is defined as ≤30% residual stenosis with timi iii flow and no evidence of dissection. exclusion criteria: * history of stroke within past 6 months; * history of mi or thrombolysis within 72 hours of randomization; * history of previous target vessel perforation; * prior vascular brachytherapy; * angiographic evidence of thrombus or dissection within the target vessel; * intervention of another coronary lesion \<60 days before index procedure day or planned following index procedure; * target lesion is in the left main or vessel ostium and has excessive calcification or tortuosity or involves bifurcation disease of vessel ≥2.5 mm; * target lesion is planned to be treated with something other than ptca (i.e. stent, cutting balloon, atherectomy, vbt, etc.); * uncontrollable allergies to procedure medications, materials, or contrast; * patient has previous stent procedure with any drug-coated or drug eluting stent device in the target coronary vessel; * known sensitivity to paclitaxel or other antimitogenic agent; * patient has a stent sandwich (a stench previously deployed within another stent; * pre-procedure ckmb \>2x uln or positive troponin; * creatinine \>2.0 mg/dl; * leukocyte \<3500/ml; * platelet \ 750,000 ml; * currently taking or must resume warfarin; * patient is contraindicated for anti-platelet therapy or it will need to be withdrawn for a planned procedure; * the patient is currently participating in another investigational drug or device study that has not completed its primary endpoint or that clinically interferes with the endpoints of this study;

Keywords: bare metal in-stent restenosis paclitaxel coated balloon catheter drug coated balloon coronary artery disease