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

Study Overview
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Brief Summary
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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.

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

Conditions
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In-Stent Restenosis

Intervention / Treatment
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* Device: Lutonix Paclitaxel-Coated Balloon


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lutonix Catheter<br> | Device: Lutonix Paclitaxel-Coated Balloon<br>* PTCA<br>* Other names: Drug Coated Balloon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Diameter Stenosis (%DS) in the Analysis Segment |  | 6 months | 
| Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months | Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Lumen Loss | Change in (loss of) lumen diameter from baseline through 6 months in the analysis segment (including the treated segment and 5mm proximal and distal). | 6 months | 
| MACE Rate | Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR). | 30 Days | 
| Binary Restenosis | Subjects with percent diameter stenosis >50% in the analysis segment. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bare Metal In-Stent Restenosis, Paclitaxel Coated Balloon Catheter, Drug Coated Balloon, Coronary Artery Disease