Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Margo Klomp
ORCID ID
Contact details
Academic Medical Centre Amsterdam
University of Amsterdam
Department of Interventional Cardiology
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 7883
trias@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR998
Study information
Scientific title
Acronym
TRIAS-HR
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Coronary artery lesions with a high risk of restenosis and an indication for percutaneous coronary treatment
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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
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
Overall trial start date
01/03/2007
Overall trial end date
01/03/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
1300
Participant 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
Recruitment start date
01/03/2007
Recruitment end date
01/03/2013
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre Amsterdam
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
Department of Interventional Cardiology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
Publication citations
-
Results
Klomp M, Beijk MA, Varma C, Koolen JJ, Teiger E, Richardt G, Bea F, van Geloven N, Verouden NJ, Chan YK, Woudstra P, Damman P, Tijssen JG, de Winter RJ, 1-year outcome of TRIAS HR (TRI-stent adjudication study-high risk of restenosis) a multicenter, randomized trial comparing genous endothelial progenitor cell capturing stents with drug-eluting stents., JACC Cardiovasc Interv, 2011, 4, 8, 896-904, doi: 10.1016/j.jcin.2011.05.011.
-
Klomp M, Beijk MA, Verouden NJ, Tijssen JG, de Winter RJ, , Design and rationale of the TRI-stent adjudication study (TRIAS) program., Am. Heart J., 2009, 158, 4, 527-532.e1, doi: 10.1016/j.ahj.2009.07.022.
-
Beijk MA, Klomp M, Verouden NJ, van Geloven N, Koch KT, Henriques JP, Baan J, Vis MM, Scheunhage E, Piek JJ, Tijssen JG, de Winter RJ, Genous endothelial progenitor cell capturing stent vs. the Taxus Liberte stent in patients with de novo coronary lesions with a high-risk of coronary restenosis: a randomized, single-centre, pilot study., Eur. Heart J., 2010, 31, 9, 1055-1064, doi: 10.1093/eurheartj/ehp476.