Elective PCI, Drug-eluting stent, Endothelial progenitor cells, High risk of restenosis
Conditions
Interventions
Sponsors
Investigator-initiated study. AMC-UvA
Eligibility
Inclusion criteria
Inclusion criteria: Clinically stable patients undergoing a PCI for a native, de novo, coronary artery lesion(s), are candidates for entry into this study. A target lesion is considered to be at a high risk of restenosis if one or more of the following apply: 1. A chronic total occlusion; 2. A lesion with a length equal to or greater than 20 mm; 3. A lesion in a coronary artery vessel with a diameter equal to or smaller than 2.8 mm (by visual estimation); 4. Any lesion in a patient with diabetes mellitus (independent of lesion length or vessel diameter).
Exclusion criteria
Exclusion criteria: 1. Younger than 18 years of age; 2. Any target lesion located in the left main coronary artery; 3. Any target lesion with involvement of a side branch, which is equal to or greater than 2.0 mm in diameter by visual estimation; 4. Any restenotic target lesion; 5. Any target lesion in an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft; 6. Urgent need for revascularization; 7. ST Elevation Myocardial Infarction (STEMI) within the past six weeks; 8. Ventricular tachyarrhythmias within the past week; 9. Known renal insufficiency (e.g. serum creatinin level of more than 200 ìgram/L); 10. Platelet count of less than 100,000 cells/ mm3 or more than 700,000 cells/ mm3, a WBC of less than 3,000 cells/ mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis); 11. History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days of randomization; 12. History of a hemorrhagic stroke at any time, or stroke or transient ischemic accident (TIA) of any etiology within 30 days of randomization; 13. Previous or scheduled chemotherapy or radiotherapy within 30 days prior or after the procedure; 14. On immune-suppression therapy or with known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.); 15. Severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure over 100 mmHg, after treatment); 16. Contraindication for treatment with the Genous™ EPC capturing stent, such as previous administration of murine therapeutic antibodies and exhibition of sensitization through the production of Human Anti-Murine Antibodies (HAMA); 17. Contraindication(s) for treatment with the PES or SES; 18. Known hypersensitivity or contraindication to aspirin, heparin or clopidogrel; 19. Elective surgery, planned within the first 6 months after the procedure that requires discontinuing either aspirin or clopidogrel; 20. Previous heart transplant or any other organ transplant; 21. Previous participation in this study; 22. Circumstances that prevent follow-up (no permanent home or address, transient, etc.); 23. Women who are pregnant or who are of childbearing potential who do not use adequate contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The primary endpoint is target lesion failure within one year, defined as the composite of cardiac death, myocardial infarction (unless documented to arise from a non-treated coronary artery) and clinically driven repeat revascularization of the treated target lesion. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: 1. Procedural success, defined as a less than 20% residual stenosis by off-line QCA and TIMI 3 flow post PCI procedure of the treated vessel; 2. Target lesion revascularization within one, two, three, four, or five years; 3. Target lesion failure within two, three, four, or five years; 4.Target vessel revascularization within one, two, three, four, or five years; 5. Target vessel failure within one, two, three, four, or five years; 6. In-stent late loss within one year; 7. In-segment late loss within one year; 8. Stent thrombosis within one, two, three, four, or five years; 9. Hospitalization for acute coronary syndrome within one, two, three, four, and five years; 10. Cardiac death or myocardial infarction within one, two, three, four, or five years | — |
Contacts
Public ContactTRIAS investigators
Academic Medical Center Amsterdam- University of Amsterdam dept. of interventional cardiology
Outcome results
None listed