TRI-stent Adjudication Study - High risk of Restenosis

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR998
• Date of registration: 14/06/2007
• Primary sponsor: Academic Medical Center (AMC), Dept. of Interventional Cardiology
• 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 - TRIAS-HR
• Date of first enrolment: 1/3/2007
• Target sample size: 1300
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=998
• Study type: intervention
• Study design: Randomised: Yes; Masking: Single; Control: Not applicable; Group: Parallel; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: TRIAS investigators

• Name: TRIAS investigators

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Elective Percutaneous Coronary Intervention (PCI), Drug-eluting stent, Endothelial progenitor cells, Restenosis

Intervention(s)

Elective PCI with stent placement

Primary Outcome(s)

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(s)

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

Secondary ID(s)

ISRCTN74297220

Source(s) of Monetary Support

Academic Medical Center (AMC), Dept. of Interventional Cardiology