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 (XERES)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Restenosis
• Intervention / Treatment: Device: Xience V®

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31403
    • Hôpital de Rangueil - CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xience V®	Device: Xience V®; Placement of a Xience V® stent within a restenosed bare metal stent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Didier Carrie, MD, Hôpital de Rangueil - CHU

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: April 14, 2009
• First Submitted That Met QC Criteria: April 15, 2009
• First Posted (Estimate): April 16, 2009

Study Record Updates

• Last Update Posted (Estimate): September 6, 2012
• Last Update Submitted That Met QC Criteria: September 5, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Stents; Coronary Artery Disease; Drug eluting stent; Angioplasty; Myocardial ischemia; Stent thrombosis; Coronary Disease; Coronary artery stenosis; Vascular disease; Coronary Restenosis; Chronic coronary occlusion
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis; Coronary Restenosis
• Other Study ID Numbers: 330704