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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Healing Responses After Treatment of Bare Metal Stent Restenosis With Implantation of an Everolimus-eluting Xience V Stent Versus Use of a Paclitaxel-eluting Balloon: Optical Coherence Tomography Study

Conditions
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Restenosis

Intervention / Treatment
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* Device: Sequent Please Paclitaxel eluting balloon
* Device: Xience V everolimus eluting stent


Participation Criteria
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Eligibility Criteria
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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. -

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>SeQuent Please Drug-eluting balloon | Device: Sequent Please Paclitaxel eluting balloon<br>* Sequent Please Paclitaxel eluting balloon<br>|
| Active Comparator: 2<br>Xience V Drug-eluting stent | Device: Xience V everolimus eluting stent<br>* Xience V everolimus eluting stent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent strut coverage and stent strut apposition(assessed with OCT) |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumen Loss (in-stent) at 9 months In-segment Late Lumen Loss at 9 months Cumulative MACE rate at 9 months Stent thrombosis at all follow-ups Target vessel revascularisation (TVR) at 12 months Device success |  | 9 months, 12 months, yearly until 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, Restenosis, Drug-eluting stent, Drug-eluting balloon, Optical Coherence Tomography