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

Phase 1

Completed

Brief 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.

Recruitment & Eligibility

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;

Arm && Interventions

Group	Intervention	Description
Lutonix Catheter	Lutonix Paclitaxel-Coated Balloon	-

Primary Outcome Measures

Name	Time	Method
Percent Diameter Stenosis (%DS) in the Analysis Segment	6 months
Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months	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.

Secondary Outcome Measures

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

Locations (8): Kerckhoff Klinik
🇩🇪
Bad Nauheim, Germany
Alte Clinic Center for Cardiology
🇩🇪
Hamburg, Germany
Onze Lieve Vrouw Ziekenhuis
🇧🇪
Aalst, Belgium
Academic Medical Center
🇳🇱
Amsterdam, Netherlands
Catherina Ziekenhuis
🇳🇱
Eindhoven, Netherlands
Herzzentrum Leipzig GmbH
🇩🇪
Leipzig, Germany
Sint Antonius Ziehenhuis
🇳🇱
Nieuwegein, Netherlands
Westdeutsches Herzzentrum Essen
🇩🇪
Essen, Germany