TRI-stent Adjudication Study - Low risk of Restenosis

A randomized multi-center trial of elective revascularization with EPC capturing stenting versus bare metal stenting in patients with de novo coronary lesions with a low risk of coronary restenosis: The Genous™ EPC capturing stent versus a bare metal stent

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27491

Enrollment

1260

Registered

2007-06-14

Start date

2007-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

elective PCI, low risk of restenosis, endothelial progenitor cells, bare metal stent

Interventions

Elective PCI with stent placement

Eligibility

Inclusion criteria

Inclusion criteria: Clinically stable patients undergoing a PCI for a coronary artery lesion with a low risk of restenosis are candidates for entry into this study. A target lesion is considered to be at a low risk of restenosis if all of the following apply: 1. A de novo lesion located in a native epicardial vessel with a Reference Vessel Diameter (RVD) greater than 2.8 mm by visual estimation; 2. A de novo lesion with a length of smaller than 20 mm by visual estimation; 3. A de novo lesion with a TIMI flow equal to or greater than 1; 4. The patient does not have diabetes mellitus

Exclusion criteria

Exclusion criteria: 1. Younger than 18 years of age; 2. A target lesion located in the left main coronary artery; 3. A chronic, totally occluded (CTO) target lesion; 4. A target lesion with involvement of a side branch, which is equal to or greater than 2.0 mm in diameter by visual estimation; 5. A restenotic target lesion; 6. A target lesion in an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft; 7. A target lesion(s) with an indication for treatment with a drug-eluting stent (DES). 8. Urgent need for revascularization; 9. ST Elevation Myocardial Infarction (STEMI) within the past six weeks; 10. Ventricular tachyarrhythmias within the past week; 11. A diabetic patient ; 12. Known renal insufficiency (e.g. serum creatinin level of more than 200 ìgram/L); 13. 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); 14. History of a bleeding diathesis, or evidence of active abnormal bleeding within 30 days of randomization; 15. History of a hemorrhagic stroke at any time, or stroke or transient ischemic accident (TIA) of any etiology within 30 days of randomization; 16. Previous or scheduled chemotherapy or radiotherapy within 30 days prior or after the procedure; 17. On immune-suppression therapy or with known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.) 18. Severe hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure over 100 mmHg, after treatment) 19. 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). 20. Known hypersensitivity or contraindication to aspirin, heparin or clopidogrel; 21. Elective surgery, planned within the first 6 months after the procedure that requires discontinuing either aspirin or clopidogrel; 22. Previous heart transplant or any other organ transplant; 23. Previous participation in this study; 24. Circumstances that prevent follow-up (no permanent home or address, transient, etc.); 25. Women who are pregnant or who are of childbearing potential who do not use adequate contraception.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 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, or five years ; 10. Cardiac death or myocardial infarction within two, three, four, or five years	—

Measure

Time frame

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 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, or five years ; 10. Cardiac death or myocardial infarction within two, three, four, or five years

—

Contacts

Public ContactTRIAS investigators

Academic Medical Center Amsterdam- University of Amsterdam dept. of interventional cardiology

trias@amc.uva.nl+31 20 566 7883

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)