SEDUCE OCT Study in Coronary Artery rEstenosis:an Optical Coherence Tomography (OCT) Study
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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Sequent Please Paclitaxel eluting balloon, Xience V everolimus eluting stent
University Hospitals Leuven
University Hospital, Gasthuisberg
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT01065532
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Stents that are covered with materials that are embedded with chemicals that are gradually released into the surrounding milieu.
An analytical technique for resolution of a chemical mixture into its component compounds. Compounds are separated on an adsorbent paper (stationary phase) by their varied degree of solubility/mobility in the eluting solvent (mobile phase).
Separation systems containing a relatively long-lived parent radionuclide which produces a short-lived daughter in its decay scheme. The daughter can be periodically extracted (milked) by means of an appropriate eluting agent.
Intra-aortic Balloon Pumping
Counterpulsation in which a pumping unit synchronized with the patient's electrocardiogram rapidly fills a balloon in the aorta with helium or carbon dioxide in early diastole and evacuates the balloon at the onset of systole. As the balloon inflates, it raises aortic diastolic pressure, and as it deflates, it lowers aortic systolic pressure. The result is a decrease in left ventricular work and increased myocardial and peripheral perfusion.
Angioplasty, Balloon, Laser-assisted
Techniques using laser energy in combination with a balloon catheter to perform angioplasty. These procedures can take several forms including: 1, laser fiber delivering the energy while the inflated balloon centers the fiber and occludes the blood flow; 2, balloon angioplasty immediately following laser angioplasty; or 3, laser energy transmitted through angioplasty balloons that contain an internal fiber.
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