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

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 \<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;