Clinical trial NCT00882219: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2009-04-16
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

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.

Primary outcomes:
measure: Evaluation by QCA (Quantitative Coronary Angiography) of in-stent late loss after the implantation of the stent XIENCE V®
timeFrame: 9 months
Secondary outcomes:
measure: Evaluation by IVUS (Intra Vascular Ultrasound) of the in-stent volume obstruction percentage (%VO) after the implantation of a XIENCE V® stent
timeFrame: 9 months
measure: Evaluation by IVUS of the mean volume of neointimal hyperplasia after the implantation of a XIENCE V® stent
timeFrame: 9 months
measure: Evaluation by QCA of the in-stent binary restenosis rate
timeFrame: 9 months
measure: Evaluation of the in-segment binary restenosis rate
timeFrame: 9 months
measure: Evaluation by QCA of in-segment late loss
timeFrame: 9 months
measure: Evaluation by IVUS of the in-segment % volume obstruction after the implantation of the XIENCE V® stent
timeFrame: 9 months
measure: Evaluation by IVUS of the rate of late incomplete apposition
timeFrame: 9 months
measure: Document the number of confirmed stent thrombosis
timeFrame: 1, 8, 9, 12 and 24 months
measure: -Document the number of confirmed revascularizations (TLR, TVR)
timeFrame: 1, 8, 9, 12 and 24 months
measure: Document the rate of MACE
timeFrame: 1, 8, 9, 12 and 24 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hopital de Rangueil - Chu
Study officials:
affiliation: HOPITAL DE RANGUEIL - CHU
name: Didier Carrie, MD
role: PRINCIPAL_INVESTIGATOR
References: