Pre-procedural 3DCT Versus Angiography Guided PCI for Ostial Right Coronary Artery Lesions (NCT05172323) | Clinical Trial Compass
CompletedNot Applicable
Pre-procedural 3DCT Versus Angiography Guided PCI for Ostial Right Coronary Artery Lesions
Belgium30 participantsStarted 2022-01-13
Plain-language summary
Even with second generation drug eluting stents, rates of target lesion failure (TLF) for aorto-ostial RCA lesions remain high \[3yrs TLF 14.2%\]. Retrospective studies show that stent underexpansion and geographical stent-ostium mismatch are the main predictors for TLF. Geographical mismatch means that the stent is implanted either too distal (thereby not fully covering the lesion) or too proximal (thereby protruding too much in the aorta and hampering future engagement with guiding catheters). The investigators hypothesize that, pre-procedural 3D CT coronarography to determine the optimal C-arm angle of the X-ray system with the most accurate visualization of the aorto-ostial angle and determination of localization of calcium, could prevent geographical mismatch.
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:
* Clinically indicated non-emergent PCI for an aorta-ostial-RCA lesion defined as a significant de novo lesion \[by angiography or by physiological assessment\] for which the operator intends to fully cover the ostial RCA with stent struts
* Willing to provide informed consent
Exclusion Criteria:
* Emergent PCI indication: if the ostial RCA lesion is the culprit lesion of an acute coronary syndrome \[of note: if the ostial RCA lesion is a non-culprit lesion, patient can be included in the trial\]
* In-stent restenosis or thrombosis in the ostial RCA
* Renal insufficiency \[eGFR\<30 ml/min\]
* Known allergic reaction to contrast medium
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
Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)