A multicenter, prospective randomized study to compare vascular healing after deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) versus the Everolimus Eluting Stent in patients with Acute Coronary Syndrome by means of Optical Coherence Tomography
- Conditions
- Heart attack10011082Acute Coronary Syndrome
- Registration Number
- NL-OMON36157
- Lead Sponsor
- OrbusNeich Medical B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
See page 23 (Sec. 9.4.1) of the protocol:;9.4.1 Inclusion Criteria
Patients must meet ALL of the following criteria:;General Inclusion Criteria:
1. The patient must be *18 and * 80 years of age;;2. ST or Non-ST-segment elevation myocardial infarction (STEMI or NSTEMI) (assumed - by the investigator - to be a type 1 myocardial infarction, according to universal definition of MI; Eur Heart J. 2007; 28(20):2525-38) (1);;3. Acceptable candidate for CABG;;4. The Patient is willing to comply with specified follow-up evaluations;;5. 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).;Angiographic
6. Single de novo or non-stented restenotic lesion in a native coronary artery;;7. Patients with two-vessel coronary disease, may have undergone successful treatment (<20% diameter stenosis by visual estimate) of the non-target vessel with approved devices up to and including the index procedure but must be prior to the index target vessel treatment. Any non-target vessel or lesion intended to be treated during the index procedure or follow-up, cannot be an unprotected left main, ostial lesion, chronic total occlusion (CTO), heavily calcified, bifurcation, vein grafts, be anything requiring atherectomy, thrombectomy, or pre-treatment with anything other than balloon angioplasty;;8. Target lesion (maximum length is 20 mm by visual estimate) to be covered by a single stent of maximum 23 mm (stent coverage including at least 3 mm of healthy vessel is recommended). The lesion length should be measured after pre-dilation procedure;;9. Reference vessel diameter must be *2.5 to * 3.5 mm by visual estimate.;10. The vessel diameter should be measured after pre-dilation procedure and after intra-coronary nitroglycerin if spasm is suspected;;11. Target lesion *50% and <100% stenosed by visual estimate.
See page 23 (Sec. 9.4.2) of the protocol:;9.4.2. Exclusion Criteria
Patients will be excluded if ANY of the following conditions apply: ;General 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 a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated;;5. Patient requires low molecular weight heparin (LMWH) treatment postprocedure or has received a dose of LMWH *8 hours prior to index procedure;;6. Patient has received any organ transplant or is on a waiting list for any organ transplant;;7. 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 a limited life expectancy (i.e., less than 1 year);;8. 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;;9. Patient has previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies (HAMA);;10. Patient presents with cardiogenic shock;;11. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion;;12. Any significant medical condition, which in the Investigator*s opinion may interfere with the patient*s optimal participation in the study;;13. 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:
14. Unprotected left main coronary artery disease with *50% stenosis;;15. Ostial target lesion(s);;16. Totally occluded target vessel (TIMI flow 0);;17. Calcified target lesion(s) which cannot be successfully predilated;;18. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;;19. Target lesion involving bifurcation with a side branch *2.0 mm in diameter (either stenosis of both main vessel and major side branch or stenosis of just major side branch) that would require intervention of diseased side branch;;20. A significant (>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single stent;;21. Diffuse distal disease to target lesion with impaired runoff;;22. Pre-treatment with devices other than balloon angioplasty;;23. Prior stent within 10 mm of target lesion;;24. Intervention (PCI or bypass) of any lesion in the target vessel performed within the previous 6 months;;25. Intervention (PCI or bypass) of another lesion in a non-target vessel performed within 30 days prior to the index procedure;;26. planned intervention of another lesion (target vessel or non-target vessel) within 30 days following the index procedure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>See also page 20 (section 8.1) of the protocol:<br /><br><br /><br>8.1. Primary Endpoint<br /><br>Percentage of uncovered stent struts per stent at 60 days follow-up (by OCT)</p><br>
- Secondary Outcome Measures
Name Time Method