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

NCT ID: NCT00882219

Last Updated: 2012-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-07-31

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.

Conditions

Coronary Restenosis

Keywords

Drug eluting stent; Stents; Angioplasty; Chronic coronary occlusion; Stent thrombosis; Vascular disease; Myocardial ischemia; Coronary artery stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Xience V®

Group Type: EXPERIMENTAL

Xience V®

Intervention Type: DEVICE

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

Interventions

Xience V®

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

Intervention Type: DEVICE

Eligibility Criteria

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

• 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Didier Carrie, MD

Role: PRINCIPAL_INVESTIGATOR

HOPITAL DE RANGUEIL - CHU

Locations

Hopital de Rangueil - Chu

Toulouse, , France

Countries

France

Other Identifiers

330704

Identifier Type: -

Identifier Source: org_study_id