TRI-stent Adjudication Study - High risk of Restenosis|
|- candidate number||2630|
|- NTR Number||NTR998|
|- Date ISRCTN created||16-jul-2007|
|- date ISRCTN requested||9-jul-2007|
|- Date Registered NTR||14-jun-2007|
|- Secondary IDs|| |
|- Public Title||TRI-stent Adjudication Study - High risk of Restenosis|
|- Scientific Title||A randomized multi-center trial of elective revascularization with EPC capturing stenting versus drug eluting stenting in patients with de novo coronary lesions with a high risk of coronary restenosis: The Genous™ EPC capturing stent versus the paclitaxel or sirolimus eluting stent|
|- hypothesis||In this multi-center, prospective, randomized trial a total of 1300 patients with coronary artery lesions with a high risk of restenosis and an indication for percutaneous coronary treatment are randomized to evaluate the non-inferiority of the Genous™ EPC capturing stent as compared to the Taxus® paclitaxel eluting stent (PES) or Cypher® sirolimus eluting stent (SES). The Genous™ EPC capturing stent is coated with an antibody that captures circulating endothelial progenitor cells (EPCs) for accelerated natural healing|
|- Healt Condition(s) or Problem(s) studied||Elective Percutaneous Coronary Intervention (PCI), Drug-eluting stent, Endothelial progenitor cells, Restenosis|
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- planned startdate ||1-mrt-2007|
|- planned closingdate||1-mrt-2013|
|- Target number of participants||1300|
|- Interventions||Elective PCI with stent placement|
|- Primary outcome||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 outcome||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
|- Trial web site||http://www.triasrandomization.org|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| TRIAS investigators|
|- CONTACT for SCIENTIFIC QUERIES|| TRIAS investigators|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Dept. of Interventional Cardiology|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Dept. of Interventional Cardiology|
|- Brief summary||Objectives
The primary objective of this study is to show non-inferiority of the Genous EPC capturing stent compared to the Taxus Liberté paclitaxel eluting stent or the Cypher sirolimus eluting stent in its capacity to prevent target lesion failure within one year in statin treated patients undergoing PCI of a de novo, coronary artery lesion(s) with a high risk of restenosis.
The secondary objective of this study is to show superiority of the Genous EPC capturing stent relative to the Taxus Liberté paclitaxel eluting stent or the Cypher sirolimus eluting stent with regard to the long-term incidence of (potentially stent thrombosis related) cardiac death or myocardial infarction.
In this European, multi-center, prospective, randomized trial a total of 1300 clinically stable patients with coronary artery lesions with a high risk of restenosis and an indication for elective percutaneous coronary treatment are randomized. A target lesion is considered to be at 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).
Suitable candidates are either patients with stable exercise-induced angina or patients stabilized after an episode of unstable angina or non-ST elevation myocardial infarction. Furthermore, all patients entered into this trial have lesions suitable for treatment with either study stent. Patients must have been on statin therapy for at least seven days. Patients with coronary artery lesions considered at low risk for restenosis are excluded from this trial.
Randomization and treatment
All included patients are randomly assigned in a 1:1 ratio to the Genous EPC capturing stent or a drug eluting stent.
Multiple stent placement is allowed. The randomized treatment assignment must be followed for all high-risk target lesions and for low-risk target lesions located in the same vessel as a high-risk target lesion. Low-risk target lesions in non-target vessels, if present, may be treated with a bare metal stent or the randomly assigned active stent at the discretion of the investigator.
Clopidogrel is started before or during PCI procedure and continued on a daily basis for a minimum of one month in case of Genous EPC capturing stent placement, for at least six months in case of Taxus Liberté paclitaxel eluting stent placement, and for at least three months in case of Cypher sirolimus eluting stent placement. The prescribed statin should be atorvastatin in a dosage of at least 40 mg or other statins in equivalent dosages and should be continued for the duration of the study.
Patients are followed clinically by telephone contact at 30 days, six months, one year, two, three, four and five years following the index stenting procedure.
Scheduling of angiographic evaluation of the treated lesion(s) is at the discretion of the treating physician. Repeat coronary angiography, if performed, is preferably scheduled after twelve months and angiograms should be suitable for off-line quantitative coronary angiography.
The primary efficacy 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.
The main long-term endpoint is defined as cardiac death or myocardial infarction (unless documented to unequivocally arise from a non-treated coronary artery) within five years.
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, (3) target lesion failure, (4) target vessel revascularization, (5) target vessel failure, (6) in-stent late loss, (7) in-segment late loss, (8) stent thrombosis, (9) hospitalization for acute coronary syndrome, (10) cardiac death or myocardial infarction.
|- Main changes (audit trail)|
|- RECORD||14-jun-2007 - 16-jul-2007|
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