PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis

A Prospective, Multicenter, European Registry Investigating the Lutonix Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis Within Bare-Metal Stents

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.

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 <100,000 mL or >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;