TRI-stent Adjudication Study - Low risk of Restenosis
- Conditions
- elective PCI, low risk of restenosis, endothelial progenitor cells, bare metal stent
- Registration Number
- NL-OMON27491
- Lead Sponsor
- Investigator initiated study, AMC-UvA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1260
Clinically stable patients undergoing a PCI for a coronary artery lesion with a low risk of restenosis are candidates for entry into this study.
A target lesion is considered to be at a low risk of restenosis if all of the following apply:
1. A de novo lesion located in a native epicardial vessel with a Reference Vessel Diameter (RVD) greater than 2.8 mm by visual estimation;
2. A de novo lesion with a length of smaller than 20 mm by visual estimation;
3. A de novo lesion with a TIMI flow equal to or greater than 1;
4. The patient does not have diabetes mellitus
1. Younger than 18 years of age;
2. A target lesion located in the left main coronary artery;
3. A chronic, totally occluded (CTO) target lesion;
4. A target lesion with involvement of a side branch, which is equal to or greater than 2.0 mm in diameter by visual estimation;
5. A restenotic target lesion;
6. A target lesion in an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft;
7. A target lesion(s) with an indication for treatment with a drug-eluting stent (DES).
8. Urgent need for revascularization;
9. ST Elevation Myocardial Infarction (STEMI) within the past six weeks;
10. Ventricular tachyarrhythmias within the past week;
11. A diabetic patient ;
12. Known renal insufficiency (e.g. serum creatinin level of more than 200 ìgram/L);
13. 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);
14. History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days of randomization;
15. History of a hemorrhagic stroke at any time, or stroke or transient ischemic accident (TIA) of any etiology within 30 days of randomization;
16. Previous or scheduled chemotherapy or radiotherapy within 30 days prior or after the procedure;
17. On immune-suppression therapy or with known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
18. Severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure over 100 mmHg, after treatment)
19. 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).
20. Known hypersensitivity or contraindication to aspirin, heparin or clopidogrel;
21. Elective surgery, planned within the first 6 months after the procedure that requires discontinuing either aspirin or clopidogrel;
22. Previous heart transplant or any other organ transplant;
23. Previous participation in this study;
24. Circumstances that prevent follow-up (no permanent home or address, transient, etc.);
25. Women who are pregnant or who are of childbearing potential who do not use adequate contraception.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The secondary endpoints are:<br>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;<br>2. Target lesion revascularization within two, three, four, or five years;<br>3. Target lesion failure within two, three, four, or five years;<br>4. Target vessel revascularization within one, two, three, four, or five years;<br>5. Target vessel failure within one, two, three, four, or five years;<br>6. In-stent late loss within one year;<br>7. In-segment late loss within one year;<br>8. Stent thrombosis within one, two, three, four, or five years;<br>9. Hospitalization for acute coronary syndrome within one, two, three, four, or five years ;<br>10. Cardiac death or myocardial infarction within two, three, four, or five years<br>