Combo Bio-Engineered Sirolimus Eluting Stent Placement Long-Term Healing Pattern Assessment by Optical Coherence Tomography

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1. The patient must be *18 and * 80 years of age;
2. Device and procedural success at the index procedure;
3. The Patient is willing to comply with specified follow-up evaluations;
4. The Patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC), Institutional Review Board (IRB), or Human Research Ethics Committee (HREC).

Exclusion Criteria

1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test;
2. Impaired renal function (serum creatinine >2.0 mg/dL or 177 *mol/l) or on dialysis;
3. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3 or a WBC<3,000 cells/mm3;
4. Patient has other medical illness (e.g., cancer, known malignancy, or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with
5. a limited life expectancy (i.e., less than 1 year);
6. Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy, sirolimus, everolimus and/or contrast sensitivity that cannot be adequately pre-medicated;
7. Patient has received any organ transplant or is on a waiting list for any organ transplant;
8. Any significant medical condition, which in the Investigator*s opinion may interfere with the patient*s optimal participation in the study;
9. Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up;;Angiographic exclusion criteria
10. Patients treated for in-stent restenosis of the index procedure Combo stent during follow-up;
11. Patients treated for in-segment stenosis of the index procedure Combo stent during follow-up;
12. Patients treated for a bifurcation lesion with a 2 stent strategy at the index procedure during follow-up;
13. Patients treated in a bypass graft at the index procedure;
14. Patients with >1 overlapping Combo stent at the index procedure;
15. Patient with unsuitable anatomy for OCT (tortious, heavily calcified, small distal stent).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>For all analyses the findings at each individual timepoint and the * between<br /><br>timepoints will be assesed<br /><br>- OCT findings on strut coverage (binary and thickness), neointimal morphology,<br /><br>strut malapposition, incidence of intracoronary thrombi and late loss (late<br /><br>tissue growth, plaque volume, lumen cross sectional area).<br /><br>- Quantitative Coronary Angiography analyses of minimal lumen diameter, mean<br /><br>lumen diameter, maximum percent stenosis, mean stenosis and late lumen loss.</p><br>

Secondary Outcome Measures