Pre-procedural 3DCT Versus Angiography Guided PCI for Ostial Right Coronary Artery Lesions
- Conditions
- Coronary Artery Disease
- Interventions
- Other: Angiography guided PCIDevice: 3DCT-scan
- Registration Number
- NCT05172323
- Lead Sponsor
- Ziekenhuis Oost-Limburg
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Angiography-guided group Angiography guided PCI PCI guided by operator and IVUS 3DCT-guided group 3DCT-scan PCI guided with 3DCT results and IVUS
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Procedural radiation dose Procedural Expressed in mGy
Volume of contrast agent administered Procedural Expressed in mL
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 The percentage of patients who need an additional stent after the final IVUS has shown that the ostium was not fully covered
Calcified lesions Procedural Calcium score as determined by 3DCT will be correlated with the maximum calcium arc on IVUS
Procedural duration from first puncture of artery to skin closure Procedural Expressed in minutes
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
Stent sizing Procedural Predicted stent diameter and length by 3DCT will be compared with the effectively implanted stent size
Calcium modification Procedural Prediction of calcium modification pre-IVUS compared with IVUS based strategy of calcium modification
MACCE at 30 days follow-up 30 days after PCI 30 days event rate \[death, non-fatal MI, non-fatal stroke, definite or probable stent thrombosis, target lesion failure\]
Trial Locations
- Locations (1)
Ziekenhuis Oost-Limburg
🇧🇪Genk, Limburg, Belgium