TRI-stent Adjudication Study - High risk of Restenosis
- Conditions
- Elective PCI, Drug-eluting stent, Endothelial progenitor cells, High risk of restenosis
- Registration Number
- NL-OMON28696
- Lead Sponsor
- Investigator-initiated study. AMC-UvA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 1300
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method