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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
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.
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)
Distance between the aorta-ostial junction and the most proximal protruding stent strut (in mm).
Time frame: Procedural
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
Time frame: 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
Time frame: Procedural
Volume of contrast agent administered
Expressed in mL
Time frame: Procedural
Procedural radiation dose
Expressed in mGy
Time frame: Procedural
Procedural duration from first puncture of artery to skin closure
Expressed in minutes
Time frame: Procedural
Minimal luminal area (MLA)
The predicted MLA by 3DCT will be compared with the MLA prior to stent placement as obtained with IVUS
Time frame: Procedural
Stent sizing
Predicted stent diameter and length by 3DCT will be compared with the effectively implanted stent size
Time frame: 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
Time frame: Procedural
Calcium modification
Prediction of calcium modification pre-IVUS compared with IVUS based strategy of calcium modification
Time frame: Procedural
Calcified lesions
Calcium score as determined by 3DCT will be correlated with the maximum calcium arc on IVUS
Time frame: Procedural
MACCE at 30 days follow-up
30 days event rate \[death, non-fatal MI, non-fatal stroke, definite or probable stent thrombosis, target lesion failure\]
Time frame: 30 days after PCI
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