Coronary Artery Disease
Conditions
Keywords
Right coronary artery, Computed tomography
Brief 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.
Interventions
DEVICE3DCT-scan
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.
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.
Sponsors
Ziekenhuis Oost-Limburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessor of the IVUS images will be blinded to treatment arm
Intervention model description
A prospective, investigator-initiated, single-centre, randomized-controlled, assessor blinded pilot trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geographical mismatch as quantified by intra-coronary ultrasound (IVUS) | Procedural | Distance between the aorta-ostial junction and the most proximal protruding stent strut (in mm). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of contrast agent administered | Procedural | Expressed in mL |
| Procedural radiation dose | Procedural | Expressed in mGy |
| Procedural duration from first puncture of artery to skin closure | Procedural | Expressed in minutes |
| Minimal luminal area (MLA) | Procedural | The predicted MLA by 3DCT will be compared with the MLA prior to stent placement as obtained with IVUS |
| Geographical mismatch as quantified by intra-coronary ultrasound (IVUS) | Procedural | 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 |
| Stent expansion | Procedural | Expressed as the minimal stent area (MSA) determined by IVUS, divided by the reference luminal area in the healthy distal landing zone |
| Calcium modification | Procedural | Prediction of calcium modification pre-IVUS compared with IVUS based strategy of calcium modification |
| Calcified lesions | Procedural | Calcium score as determined by 3DCT will be correlated with the maximum calcium arc on IVUS |
| MACCE at 30 days follow-up | 30 days after PCI | 30 days event rate \[death, non-fatal MI, non-fatal stroke, definite or probable stent thrombosis, target lesion failure\] |
| Stent sizing | Procedural | Predicted stent diameter and length by 3DCT will be compared with the effectively implanted stent size |
Countries
Belgium
Outcome results
None listed