Pre-procedural 3DCT Versus Angiography Guided PCI for Ostial Right Coronary Artery Lesions

Study Overview
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Brief Summary
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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.

Official Title
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Pre-procedural 3D Reconstructed Computer Tomography Versus Angiography Guided Percutaneous Coronary Intervention for Ostial Right Coronary Artery Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: 3DCT-scan
* Other: Angiography guided PCI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, investigator-initiated, single-centre, randomized-controlled, assessor blinded pilot trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3DCT-guided group<br>PCI guided with 3DCT results and IVUS | Device: 3DCT-scan<br>* 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.<br>|
| Placebo Comparator: Angiography-guided group<br>PCI guided by operator and IVUS | Other: Angiography guided PCI<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Right coronary artery, Computed tomography