SEDUCE OCT Study in Coronary Artery rEstenosis:an Optical Coherence Tomography (OCT) Study

Background: The optimal treatment of bare metal stent restenosis (implantation of a drug-eluting stent, simple balloon dilatation, CABG) is still not defined. The most used option nowadays is the implantation of a drug-eluting stent (DES). However, this procedure implies application of a double metal layer in the vessel wall, which is linked to delayed healing. Furthermore there might be a higher risk of malapposition of both struts of the bare metal and the newly implanted drug-eluting stents. These phenomenon's might give rise to an increased risk of stent thrombosis in this patient population. Recently, drug-eluting balloons (DEB) were proposed as a new treatment strategy for bare metal stent restenosis. The initial results of this technique look promising.

Aim: To compare healing processes after treatment of BMS ISR with balloon dilatation using DEB versus implantation of DES.

Methods: 50 patients with BMS restenosis (SVG and bifurcation lesions will be excluded) will be randomized into two treatment groups: SeQuent Please drug-eluting balloon dilatation (group I) versus implantation of an everolimus-eluting Xience V stent (group II). At 9 months, a control angiography with OCT pullback of the treated segment is planned.

Inclusion criteria

• Patient older than 18 years
• written informed consent available
• patient eligible for percutaneous coronary intervention
• patients with a single or multiple re-stenotic lesion(s) in a previously stented area of a coronary artery (irrelevant whether BMS or DES)
• Target reference vessel diameter measured by QCA: 2-4 mm
• Target lesion length measured by QCA < 24 mm
• Target lesion stenosis measured by QCA: > 70%- < 100%
• Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.

Exclusion criteria

• Left ventricular ejection fraction of < 30%
• Impaired renal function (serum creatinine > 2.0 mg/dl)
• Target lesion located in bifurcation
• Previous and/or planned brachytherapy of target vessel
• Lesion of the left main trunk > 50%, unprotected
• Known allergies to antiplatelet, anticoagulation therapy, contrast media, paclitaxel or everolimus
• Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
• Patients with a life expectancy of less than one year
• Patients who intend to have a major surgical intervention within 6 months of enrolment in the study.
• Patient currently enrolled in other investigational device or drug trial
• Patient not able or willing to adhere to follow-up visits
• Patients who previously participated in this study. -