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| [ ...Back to search results ] | [ Print-friendly version ] |
| TRI-stent Adjudication Study - High risk of Restenosis |
| ISRCTN | ISRCTN74297220 |
| ClinicalTrials.gov identifier | |
| Public title | TRI-stent Adjudication Study - High risk of Restenosis |
| Scientific title | |
| Acronym | TRIAS-HR |
| Serial number at source | NTR998 |
| Study hypothesis | In this multicentre, prospective, randomised trial a total of 1300 patients with coronary artery lesions with a high risk of restenosis and an indication for percutaneous coronary treatment are randomised to evaluate the non-inferiority of the Genous™ Endothelial Progenitor Cell (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 EPCs for accelerated natural healing. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Approval received from the Academic Medical Centre Medical Ethics Committee on the 12th March 2007 (ref: MEC 07/041 # 07.17.0400). |
| Study design | Multicentre prospective randomised controlled parallel group trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Coronary artery lesions with a high risk of restenosis and an indication for percutaneous coronary treatment |
| Participants - inclusion criteria |
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) |
| Participants - 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 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 |
| Anticipated start date | 01/03/2007 |
| Anticipated end date | 01/03/2013 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 1300 |
| Interventions |
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 randomised 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® PES placement, and for at least three months in case of Cypher® SES 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. Added 01/02/10: Enrollment for this trial finished on the 19 of February 2009 |
| Primary outcome measure(s) | 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 measure(s) |
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
2. Target lesion revascularisation within one, two, three, four, or five years 3. Target lesion failure within two, three, four, or five years 4.Target vessel revascularisation 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. Hospitalisation 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 |
| Sources of funding | Academic Medical Centre (AMC) (Netherlands) |
| Trial website | http://www.triasrandomization.org |
| Publications |
1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19781410
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19933225 3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21851905 |
| Contact name | Dr Margo Klomp |
| Address |
Academic Medical Centre Amsterdam
University of Amsterdam Department of Interventional Cardiology |
| City/town | Amsterdam |
| Zip/Postcode | 1105 AZ |
| Country | Netherlands |
| Tel | +31 (0)20 566 7883 |
| trias@amc.uva.nl | |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Address |
Department of Interventional Cardiology
P.O. Box 22660 |
| City/town | Amsterdam |
| Zip/Postcode | 1100 DD |
| Country | Netherlands |
| Sponsor website: | http://www.amc.uva.nl#http://www.amc.uva.nl/ |
| Date applied | 16/07/2007 |
| Last edited | 03/01/2012 |
| Date ISRCTN assigned | 16/07/2007 |
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| © 2012 ISRCTN unless otherwise stated. | |
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