TRI-stent Adjudication Study - High risk of Restenosis
| ISRCTN | ISRCTN74297220 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74297220 |
| Secondary identifying numbers | NTR998 |
- Submission date
- 16/07/2007
- Registration date
- 16/07/2007
- Last edited
- 03/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Margo Klomp
Scientific
Scientific
Academic Medical Centre Amsterdam
University of Amsterdam
Department of Interventional Cardiology
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 7883 |
|---|---|
| trias@amc.uva.nl |
Study information
| Study design | Multicentre prospective randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | TRIAS-HR |
| Study objectives | 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(s) | Approval received from the Academic Medical Centre Medical Ethics Committee on the 12th March 2007 (ref: MEC 07/041 # 07.17.0400). |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2007 |
| Completion date | 01/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 1300 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 01/03/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre Amsterdam
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Interventional Cardiology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl#http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/10/2009 | Yes | No | |
| Results article | results | 01/05/2010 | Yes | No | |
| Results article | results | 01/08/2011 | Yes | No |
