Clinical Evaluation of Patients With Everolimus-eluting Stent Xience V® Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period

Study Overview
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Brief Summary
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Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent  Xience V®  implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up period.

Official Title
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XERES Trial: Clinical Evaluation of Patients With Everolimus-eluting Stent  Xience V®  Implanted in the Treatment of Restenosis in Non-coated Metallic Stent (BMS In-stent Restenosis) During a 2 Year Clinical Follow-up Period

Conditions
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Coronary Restenosis

Intervention / Treatment
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* Device: Xience V®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older Patients affiliated to a social security or equivalent regimen Patients agreeing to participate in the study (Patient with signed informed consent ) Patients with evidence of myocardial ischemia (stable or unstable angina, silent ischemia, positive functional exploration or a reversible modification in the ECG consistent with ischemia). Patient acceptable candidate for CABG surgery Patient agreeing to undergo all protocol scheduled follow-up examinations. Patients who tolerate the association Aspirin (dosed 75 to 160 mg/day) and Clopidogrel at 75 mg/day for at least 6 months Angiographic inclusion criteria: Patient with de novo and sole in-stent restenosis (focal, diffuse or proliferative) in a non-coated metallic stent with or without any other coronary lesions. Patient with target reference vessel diameter between 2.5 and 4 mm by visual estimate Patient with a target lesion ≤ 22mm by visual estimate Patient with a target lesion in an artery with a visual estimate of the restenosis between 50 and 99% and a TIMI flow grade > 1 Patient with multiple lesions, the other lesions have been treated with success Exclusion Criteria: Patient in emergency Patient pregnant Patient nursing Patient unable to give informed consent personally. Patient with myocardial infarction within the previous 72 hours. Patient with limited life expectancy (lesser than 1 year post-inclusion) Patient with unstable arrhythmia Patient with left ventricular ejection fraction (LVEF) lesser than 30% Patient receiver of a cardiac or any other organ transplantation or candidate to an organ transplant Patient who receive or scheduled to receive chemo- or radio- therapy within the 30 days prior to any protocol-related procedure. Patient treated with immunosuppressives or for known immunodepressive or auto-immune pathologies Patient receiving chronically anticoagulant therapy with an INR greater than 2.5 Patient with known hypersensitivity or contraindications to anti-platelet drugs, everolimus, heparin, chromium cobalt alloys, nickel, tungsten, acrylic- or fluoro- polymers or sensitivity to angiographic contrast agents. Patient with planned elective surgery requiring the interruption or discontinuation of anti-platelet therapy. Patient with platelet count <100 000/ mm3 or >700 000mm3 ; WBC counts <3 000/mm3 or known or suspected liver disease Patient with severe renal insufficiency (creatinine clearance rate < 30 ml/min), or under dialysis Patient with an history of coagulopathy refusing blood transfusion Patient who had a stroke/cerebrovascular accident or transient cerebrovascular ischemia in the preceding 6 months Patient with urinary or gastro-intestinal bleed in the preceding 6 months Patient with other known serious medical illness or known history of substance abuse (alcohol, drugs) that might result in non-compliance to the investigational plan, or interfere with the results or diminish the life expectancy to less than a year. Patient enrolled in an interventional study with another medical device or drug Angiographic exclusion criteria Patient with in-stent restenosis located on the left main on the coronary by-pass Patient with a lesion of the in-stent restenosis located in a bifurcation including a lateral branch of diameter > 1.5mm Patient with the target vessel totally occluded Patient with a lesion of the restenosis previously treated with another device (with the exception of balloon-tipped catheter) such as a cutting balloon, an atherectomy, laser, brachytherapy or any another medicated stent. Patient with thrombus in the target vessel Patient with aorto-ostiale lesions Patient with previous failures of multiple lesions treated by angioplasty.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xience V®<br> | Device: Xience V®<br>* Placement of a Xience V® stent within a restenosed bare metal stent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation by QCA (Quantitative Coronary Angiography) of in-stent late loss after the implantation of the stent XIENCE V® |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation by IVUS (Intra Vascular Ultrasound) of the in-stent volume obstruction percentage (%VO) after the implantation of a XIENCE V® stent |  | 9 months | 
| Evaluation by IVUS of the mean volume of neointimal hyperplasia after the implantation of a XIENCE V® stent |  | 9 months | 
| Evaluation by QCA of the in-stent binary restenosis rate |  | 9 months | 
| Evaluation of the in-segment binary restenosis rate |  | 9 months | 
| Evaluation by QCA of in-segment late loss |  | 9 months | 
| Evaluation by IVUS of the in-segment % volume obstruction after the implantation of the XIENCE V® stent |  | 9 months | 
| Evaluation by IVUS of the rate of late incomplete apposition |  | 9 months | 
| Document the number of confirmed stent thrombosis |  | 1, 8, 9, 12 and 24 months | 
| -Document the number of confirmed revascularizations (TLR, TVR) |  | 1, 8, 9, 12 and 24 months | 
| Document the rate of MACE |  | 1, 8, 9, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug eluting stent, Stents, Angioplasty, Chronic coronary occlusion, Stent thrombosis, Vascular disease, Myocardial ischemia, Coronary artery stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis