TRI-stent Adjudication Study - Low risk of Restenosis
- Conditions
- Coronary artery lesions with a low risk of restenosis undergoing percutaneous coronary treatmentCirculatory SystemOther disorders of arteries and arterioles
- Registration Number
- ISRCTN47701105
- Lead Sponsor
- Academic Medical Centre (AMC) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1260
Clinically stable patients undergoing a Percutaneous Coronary Intervention (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 Thrombolysis in Myocardial Infarction (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 revascularisation
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 creatinine level of more than 200 µgram/L)
13. Platelet count of less than 100,000 cells/mm^3 or more than 700,000 cells/mm^3, a White Blood Cell (WBC) count of less than 3,000 cells/mm^3, 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 randomisation
15. History of a hemorrhagic stroke at any time, or stroke or Transient Ischaemic Accident (TIA) of any aetiology within 30 days of randomisation
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 greater than 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 sensitisation 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 six 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 revascularisation 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 Quantitative Coronary Angiography (QCA) and TIMI 3 flow post PCI procedure of the treated vessel<br>2. Target lesion revascularisation within two, three, four, or five years<br>3. Target lesion failure within two, three, four, or five years<br>4. Target vessel revascularisation 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. Hospitalisation 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