seduce oct study in coronary artery restenosis:an optical coherence tomography (oct) study

Conditions: Restenosis

Summary: different healing responses after treatment of bare metal stent restenosis with implantation of an everolimus-eluting xience v stent (abbott vascular) versus use of a paclitaxel-eluting sequent please balloon (bbraun): an optical coherence tomography study. a prospective, single-centre, randomized clinical trial with clinical, angiographic and oct follow-up at 9 months.

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.

Eligibility criteria:
inclusion criteria: 1. patient older than 18 years 2. written informed consent available 3. patient eligible for percutaneous coronary intervention 4. patients with a single or multiple re-stenotic lesion(s) in a previously stented area of a coronary artery (irrelevant whether bms or des) 5. target reference vessel diameter measured by qca: 2-4 mm 6. target lesion length measured by qca \< 24 mm 7. target lesion stenosis measured by qca: \> 70%- \< 100% 8. patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations. exclusion criteria: 1. left ventricular ejection fraction of \< 30% 2. impaired renal function (serum creatinine \> 2.0 mg/dl) 3. target lesion located in bifurcation 4. previous and/or planned brachytherapy of target vessel 5. lesion of the left main trunk \> 50%, unprotected 6. known allergies to antiplatelet, anticoagulation therapy, contrast media, paclitaxel or everolimus 7. pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required) 8. patients with a life expectancy of less than one year 9. patients who intend to have a major surgical intervention within 6 months of enrolment in the study. 10. patient currently enrolled in other investigational device or drug trial 11. patient not able or willing to adhere to follow-up visits 12. patients who previously participated in this study. -

Keywords: restenosis pci drug-eluting stent drug-eluting balloon optical coherence tomography