Coronary Artery Disease Clinical Trial
— REMEDEE-OCTOfficial title:
A Prospective Randomized Study to Compare Vascular Healing After Deployment of the Abluminal Sirolimus Coated Bio-Engineered (Combo) Stent Versus the Everolimus Eluting Stent in Patients With Acute Coronary Syndrome by Means of OCT
OBJECTIVE It is the objective of the REMEDEE OCT study to assess vascular healing after
deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered
Sirolimus Eluting Stent) in patients with Acute Coronary Syndrome (ACS) with single de novo
native coronary artery lesions ranging in diameter from ≥2.5 mm to ≤3.5 mm and ≤ 20 mm in
length.
STUDY DESIGN The REMEDEE OCT study is a prospective, multicenter, randomized study designed
to enroll 60 patients with ACS who will be randomized 1:1 to be treated with the Combo stent
versus the commercially available everolimus eluting stent (Xience V or Promus). Patients
will receive Optical Coherence Tomography (OCT) and Quatitative Coronary Angiography (QCA)
follow-up imaging at 60 days post procedure. Clinical follow-up is scheduled at 30, 60, 180,
360 and 540 days. Furthermore, QCA and OCT will also be performed at baseline in all
participants of the study.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 2014 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria 1. age =18 and = 80 years 2. ST or Non-ST-segment elevation MI (assumed to be a type 1) 3. Acceptable CABG candidate 4. Patient willing to comply with specified follow-up 5. 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 6. Single de novo or non-stented restenotic lesion in a native coronary artery 7. Patients with 2-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, 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 max 23 mm (stent coverage incl at least 3 mm of healthy vessel is recommended). The lesion length to be measured after pre-dilation 9. Reference vessel diameter =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 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 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 or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (<1 year) 8. Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy, sirolimus 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 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 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 26. Planned intervention of another lesion (target vessel or non-target vessel) within 30 days. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | OLV Ziekenhuis Aalst | Aalst | |
Belgium | AZ Middelheim | Antwerp | |
Finland | Satakunta Central Hospital | Pori | |
Netherlands | Academisch Medisch Centrum | Amsterdam | |
Switzerland | University Hospital Zurich | Zurich | |
United Kingdom | King's College Hospital | London |
Lead Sponsor | Collaborator |
---|---|
OrbusNeich | Genae associates |
Belgium, Finland, Netherlands, Switzerland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of uncovered stent struts per stent at follow-up (OCT) | 60 days | Yes | |
Secondary | Secondary Clinical Endpoint: Major Adverse Cardiac Events (MACE) | Major Adverse Cardiac Events (MACE)defined as a composite of death, Myocardial Infarction (MI) (Q wave or non-Q wave), emergent coronary artery bypass surgery (CABG), or justified target lesion revascularization (TLR) by repeat Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Grafting (CABG) at hospital discharge | 30, 60, 180, 360, 540 days | Yes |
Secondary | Secondary Clinical Endpoint: components of MACE: cardiac death | cardiac death | 30, 60, 180, 360, 540 days | Yes |
Secondary | Secondary Clinical Endpoints: components of MACE: MI | MI (Q wave or non-Q wave) | 30, 60, 180, 360, 540 days | Yes |
Secondary | Secondary Clinical Endpoints: components of MACE: CABG or re-PTCA of target lesion | emergent coronary artery bypass surgery (CABG), or clinically justified target lesion revascularization (TLR) by repeat PTCA or CABG at hospital discharge | 30, 60, 180, 360, 540 days | Yes |
Secondary | Secondary Clinical Endpoints: Stent thrombosis | Target vessel stent thrombosis per Academic Research Consortium (ARC) definition | 30, 60, 180, 360, 540 days | Yes |
Secondary | Secondary OCT Endpoints (1/12) | Percentage of stent strut malapposition | 60 days | No |
Secondary | Secondary OCT Endpoints (2/12) | Maximum length of segments (mm) with uncovered struts | 60 days | No |
Secondary | Secondary OCT Endpoints (3/12) | Maximum length of segments (mm) with malapposed struts | 60 days | No |
Secondary | Secondary OCT Endpoints (4/12) | Maximum malapposition distance (mm) | 60 days | No |
Secondary | Secondary OCT Endpoints (5/12) | Total malapposition volume | 60 days | No |
Secondary | Secondary OCT Endpoints (6/12) | Maximal malapposition volume | 60 days | No |
Secondary | Secondary OCT Endpoints (7/12) | Mean neointimal thickness (NIT)(strut level) | 60 days | No |
Secondary | Secondary OCT Endpoints (8/12) | Percentage of protruding struts per stent | 60 days | No |
Secondary | Secondary OCT Endpoints (9/12) | Frequency of Abnormal Intrastent Tissue (AIST) | 60 days | No |
Secondary | Secondary OCT Endpoints (10/12) | Stent Volume | 60 days | No |
Secondary | Secondary OCT Endpoints (11/12) | Lumen Volume | 60 days | No |
Secondary | Secondary OCT Endpoints (12/12) | Neointimal Hyperplasia (NIH) Volume | 60 days | No |
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