atherosclerotic plaque coronary disease
Conditions
Interventions
The patient is scheduled for intervention of coronary bifurcation lesion using
DES stents
Sponsors
Volcano Europe SA/NV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient must be greater than 18 years of age. 2. Patient is scheduled for coronary stenting of a bifurcation lesion in a native artery using Drug Eluting Stents. 3. Patient must be willing and able to read and sign the informed consent document before planned coronary intervention. 4. If the patient is female and of child bearing potential, a pregnancy test (serum HcG or urine dip stick) is negative within 7 days of the procedure. 5. Side branch lumen diameter min of >2 mm by visual, angiographic estimate. 6. Patient must agree to be available for follow-up at 30 days, 1 and 2 years after procedure. 7. Other significant lesions in different vessels should be treated successfully (residual stenosis
Exclusion criteria
Exclusion criteria: 1. The patient experiences significant hepatic disease, renal disease, lung disease and/or malignant disease with unfavorable prognosis. 2. Any contraindications for IVUS interrogation as determined by the investigator including sever vessel tortuosity and severe calcification by angiogram. The patient suffered a cerebrovascular accident within the past 6 months and has residual effects from the event. 3. The patient suffered significant (as determined by the Investigator) gastrointestinal bleeding within the past 3 months. 4. The most recent white blood cell count less than 3,000 cell/mm3 or the number of platelet is less than 100,000 cell/mm3. 5. The patient has contraindication to antithrombotic regimen or anticoagulation therapy. 6. The lesion is 0.0.1. (Medina classification). 7. The bifurcation lesion involves an anastamosis site from previous a coronary artery bypass surgery. 8. Acute MI or recent MI with CPK > 3 times the normal value prior to intervention (during index hospitalization). 9. Other significant lesion in the same vessel. 10. Other lesion in a different vessel not successfully treated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline demographics and anatomy will be displayed comparing the two treatment groups: angiogram only and angiogram with VH-IVUS. The three primary endpoints: correct identification of calcium presence, accurate measurement of lesion length for stent sizing, and correct minimal lumen CSA will be used to determine overall improved diagnostic accuracy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Niet van toepassing | — |
Countries
Netherlands
Outcome results
None listed