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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3DCT-guided group | Experimental | PCI guided with 3DCT results and IVUS |
|
| Angiography-guided group | Placebo Comparator | PCI guided by operator and IVUS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3DCT-scan | Device | A contrast CT-scan of the coronary arteries will be performed and 3D analyzed to determine the best angle for the C-arm during Percutaneous Coronary Intervention (PCI) for stent implantation. Furthermore determining the amount and localization of calcium in the right coronary artery (RCA) and diameter and length of RCA. The use of IVUS will be used to determine the degree of calcium. |
| Measure | Description | Time Frame |
|---|---|---|
| Geographical mismatch as quantified by intra-coronary ultrasound (IVUS) | Distance between the aorta-ostial junction and the most proximal protruding stent strut (in mm). | Procedural |
| Measure | Description | Time Frame |
|---|---|---|
| Geographical mismatch as quantified by intra-coronary ultrasound (IVUS) | Percentage of patients without geographical mismatch as defined by a fully covered ostium AND a maximal length between the aorta-ostial junction and the most proximal protruding stent struts not more then 3mm | Procedural |
| Geographical mismatch as quantified by intra-coronary ultrasound (IVUS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Koen Ameloot, Dr. | Ziekenhuis Oost-Limburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | Limburg | 3600 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29407132 | Background | Mitomo S, Jabbour RJ, Watanabe Y, Mangieri A, Ancona M, Regazzoli D, Tanaka A, Nakajima A, Naganuma T, Giannini F, Latib A, Nakamura S, Colombo A. Comparison of mid-term clinical outcomes after treatment of ostial right coronary artery lesions with early and new generation drug-eluting stents: Insights from an international multicenter registry. Int J Cardiol. 2018 Mar 1;254:53-58. doi: 10.1016/j.ijcard.2017.10.066. Epub 2018 Jan 28. | |
| 39878016 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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A prospective, investigator-initiated, single-centre, randomized-controlled, assessor blinded pilot trial.
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The assessor of the IVUS images will be blinded to treatment arm
|
| Angiography guided PCI | Other | Standard of care is angiography guided PCI of the ostium of the RCA. The use of IVUS will be used to determine the degree of calcium. |
|
The percentage of patients who need an additional stent after the final IVUS has shown that the ostium was not fully covered |
| Procedural |
| Volume of contrast agent administered | Expressed in mL | Procedural |
| Procedural radiation dose | Expressed in mGy | Procedural |
| Procedural duration from first puncture of artery to skin closure | Expressed in minutes | Procedural |
| Minimal luminal area (MLA) | The predicted MLA by 3DCT will be compared with the MLA prior to stent placement as obtained with IVUS | Procedural |
| Stent sizing | Predicted stent diameter and length by 3DCT will be compared with the effectively implanted stent size | Procedural |
| Stent expansion | Expressed as the minimal stent area (MSA) determined by IVUS, divided by the reference luminal area in the healthy distal landing zone | Procedural |
| Calcium modification | Prediction of calcium modification pre-IVUS compared with IVUS based strategy of calcium modification | Procedural |
| Calcified lesions | Calcium score as determined by 3DCT will be correlated with the maximum calcium arc on IVUS | Procedural |
| MACCE at 30 days follow-up | 30 days event rate [death, non-fatal MI, non-fatal stroke, definite or probable stent thrombosis, target lesion failure] | 30 days after PCI |
| Derived |
| van den Buijs DMF, Poels EM, Willems E, Cottens D, Dotremont K, De Leener K, Meekers E, Ferdinande B, Vrolix M, Dens J, Ameloot K. Three-Dimensional CT for Preprocedural Planning of PCI for Ostial Right Coronary Artery Lesions: A Randomized Controlled Pilot Trial. Circ Cardiovasc Interv. 2025 Feb;18(2):e013584. doi: 10.1161/CIRCINTERVENTIONS.123.013584. Epub 2025 Jan 29. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |