XERES: 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

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT00882219

Collaborator

(none)

102

Enrollment

Location

Arm

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Restenosis	Device: Xience V®	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

102 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Xience V®

Device: Xience V®

Placement of a Xience V® stent within a restenosed bare metal stent.

Outcome Measures

Primary Outcome Measures

Evaluation by QCA (Quantitative Coronary Angiography) of in-stent late loss after the implantation of the stent XIENCE V® [9 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.