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
Phase 3
Completed
- Conditions
- Coronary Restenosis
- Interventions
- Device: Xience V®
- Registration Number
- NCT00882219
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Xience V® Xience V® -
- Primary Outcome Measures
Name Time Method Evaluation by QCA (Quantitative Coronary Angiography) of in-stent late loss after the implantation of the stent XIENCE V® 9 months
- Secondary Outcome Measures
Name Time Method 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 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 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
Trial Locations
- Locations (1)
Hopital de Rangueil - Chu
🇫🇷Toulouse, France