angina pectoris coronary atherosclerosis
Conditions
Interventions
Stenting Procedure
Baseline angiography of the target vessel will be completed as per the
Angiographic Core Laboratory Guidelines.
Subjects presenting without documentation of prior left ventricula
IVUS follow-up in all subjects
in the IVUS sub-study (n=75
50:25 Combo to TAXUS).
Sponsors
OrbusNeich Medical B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: General Inclusion Criteria 1. The patient must be >=18 and =2.5 to =50% and
Exclusion criteria
Exclusion criteria: General Exclusion Criteria 1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test; 2. Patient has had a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure (elevated troponin or CK-MB >=2 times upper limit of normal) or >72 hours preceding the index procedure and CK and CK-MB have not returned to within normal limits at the time of procedure; 3. The patient is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate unresponsive prolonged chest pain; 4. Impaired renal function (serum creatinine >2.0 mg/dL or 177 µmol/l) or on dialysis; 5. Platelet count 700,000 cells/mm3 or a WBC =50% stenosis; 18. Ostial target lesion(s); 19. Totally occluded target vessel (TIMI flow 0); 20. Calcified target lesion(s) which cannot be successfully predilated; 21. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment; 22. Angiographic evidence of thrombus in the target lesion(s); 23. Target lesion involving bifurcation with a side branch >=2.0 mm in diameter (either stenosis of both main vessel and major side branch or stenosis of just major side branch) that would require intervention of diseased side branch; 24. A significant (>50%) stenosis proximal or distal to the target lesion that cannot be covered by same single stent; 25. Diffuse distal disease to target lesion with impaired
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent late lumen loss of the Combo Stent compared to the TAXUS® Liberté® DES at 9 months post-procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All-cause and cardiac mortality at 30 days, 9 months, 1, 2, 3, 4, and 5 years; 2. Myocardial infarction: Q-wave and non Q-wave, cumulative and individual at 30 days, 9 months, 1, 2, 3, 4, and 5 years; 3. Major Adverse Cardiac Event (MACE) at hospital discharge, 30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure; 4. Vascular complications from index procedure through hospital discharge; 5. Rate of stent thrombosis, per ARC definitions, at 30 days, 9 months, 1, 2, 3, 4 and 5 years post-procedure; 6. Change in human anti-murine antibody (HAMA) plasma levels at 30 day and 9 month follow-up compared to baseline; 7. Device success, defined as attainment of | — |
Countries
Netherlands
Outcome results
None listed