Coronary Restenosis
Conditions
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
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.
Interventions
DEVICEXience V®
Placement of a Xience V® stent within a restenosed bare metal stent.
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 (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 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 |
| Evaluation by IVUS of the in-segment % volume obstruction after the implantation of the XIENCE V® stent | 9 months |
Countries
France
Outcome results
None listed