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New treatment option for Coronary Artery Disease (CAD)
Official title "Expert IVUS-Eye" vs. IVUS-guided Left Main Bifurcation PCI
ClinicalTrials.gov ID: NCT07711106
What this study is testing
- What it's testing
- This is a prospective, randomized, controlled trial comparing two strategies for optimizing stent implantation during bifurcation stenting of the left main coronary artery (LM): an intravascular ultrasound (IVUS)-guided approach versus a "IVUS-trained eye" approach based on angiographic assessment and operator experience. All patients receive the same stent brand and procedure steps to minimize variability.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- De novo lesion in an unprotected left main coronary artery, indicated for bifurcational stenting (provisional or 2-stent)
- Patient referred for elective or delayed (non-emergency) stenting
- Technical feasibility of performing IVUS
- Signed informed consent
You likely can't join if
- ST-elevation myocardial infarction (STEMI) within the preceding 72 hours
- Cardiogenic shock
- Isolated (non-bifurcation) left main lesion
- Prior PCI in the target segment
- Diameter of one of the left main main branches \< 2 mm
- Occlusion in the proximal segment of one of the main left main branches without the possibility of simultaneous recanalization
See the full eligibility criteria
- De novo lesion in an unprotected left main coronary artery, indicated for bifurcational stenting (provisional or 2-stent)
- Patient referred for elective or delayed (non-emergency) stenting
- Technical feasibility of performing IVUS
- Signed informed consent
- ST-elevation myocardial infarction (STEMI) within the preceding 72 hours
- Cardiogenic shock
- Isolated (non-bifurcation) left main lesion
- Prior PCI in the target segment
- Diameter of one of the left main main branches \< 2 mm
- Occlusion in the proximal segment of one of the main left main branches without the possibility of simultaneous recanalization
- History of coronary artery bypass grafting (CABG)
- Severe comorbidity with expected life expectancy \< 1 year
- Participation in another treatment study
- Patient is a woman who is pregnant or nursing;
- Female patient of childbearing potential, i.e. who are not surgically sterile or post-menopausal (defined as no menses for 2 years without an alternative cause);
- IVUS is strictly required for pre-PCI lesion severity assessment
- Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 6 months in stable patients and 1 year in ACS patients;
- Known contraindication or hypersensitivity to everolimus, platinum-chromium, or to anticoagulants.
The study team makes the final eligibility decision.
Where it's taking place
- Saint Petersburg, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.