TRI-stent Adjudication Study - High risk of Restenosis
- Conditions
- Circulatory SystemOther disorders of arteries and arteriolesCoronary artery lesions with a high risk of restenosis and an indication for percutaneous coronary treatment
- Registration Number
- ISRCTN74297220
- Lead Sponsor
- Academic Medical Centre (AMC) (Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1300
Clinically stable patients undergoing a Percutaneous Coronary Intervention (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 revascularisation
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 creatinine level of more than 200 µgram/L)
10. 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)
11. History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days of randomisation
12. History of a haemorrhagic stroke at any time, or stroke or Transient Ischaemic Accident (TIA) of any aetiology within 30 days of randomisation
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 greater than 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 sensitisation 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 six 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 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 1. Procedural success, defined as a less than 20% residual stenosis by off-line Quantitative Coronary Angiography (QCA) and Thrombolysis in Myocardial Infarction (TIMI) three-flow post PCI procedure of the treated vessel<br>2. Target lesion revascularisation within one, 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, and five years<br>10. Cardiac death or myocardial infarction within one, two, three, four, or five years