United States, Denmark, France195 participantsStarted 2008-10
Plain-language summary
The purpose of this research study is to determine if Intravascular Ultrasound (IVUS) grayscale and VH (Virtual Histology)-IVUS pre-stenting can assess more accurately the location, amount, and type of a blockage than angiogram alone. Additionally, this study is to determine if IVUS grayscale and VH-IVUS guidance will result in improved acute and long term procedural outcome vs. bifurcation stenting with only angiographic guidance in native coronary arteries.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient must be greater than 18 years of age.
. Patient is scheduled for coronary stenting of a bifurcation lesion in a native artery using Drug Eluting Stents (DES).
. Patient must be willing and able to read and sign the informed consent document before planned coronary intervention.
. 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.
. Side branch lumen diameter min of \>2 mm by visual, angiographic estimate.
. Patient must agree to be available for follow-up at 30 days, 1 and 2 years after procedure.
. Other significant lesions in different vessels should be treated successfully (residual stenosis \< 30%, normal TIMI flow, no EKG modification) before treating the index bifurcation lesion.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
IVUS with VH guidance leads to better post procedural outcomes when compared
. The patient experiences significant hepatic disease, renal disease, lung disease and/or malignant disease with unfavorable prognosis.
. Any contraindications for IVUS interrogation as determined by the investigator including sever vessel tortuosity and severe calcification by angiogram.
. Side branch lumen diameter \< 2 mm by visual, angiographic estimate.
. The patient suffered a cerebrovascular accident within the past 6 months and has residual effects from the event.
. The patient suffered significant (as determined by the Investigator) gastrointestinal bleeding within the past 3 months.
. 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.
. The patient has contraindication to antithrombotic regimen or anticoagulation therapy.
. Any other patients who are judged by principal Investigator to be inappropriate for participation in the trial.