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

Coronary Artery Disease Clinical Trial

— 3DCT-RCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05172323
• Other study ID #: Z-2021107
• Status: Completed
• Phase: N/A
• Start date: January 13, 2022
• Est. completion date: February 8, 2023

Study information

• Verified date: March 2023
• Source: Ziekenhuis Oost-Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 8, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• 3DCT-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.

Other:
• Angiography guided PCI
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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Volume of contrast agent administered	Expressed in mL	Procedural
Secondary	Procedural radiation dose	Expressed in mGy	Procedural
Secondary	Procedural duration from first puncture of artery to skin closure	Expressed in minutes	Procedural
Secondary	Minimal luminal area (MLA)	The predicted MLA by 3DCT will be compared with the MLA prior to stent placement as obtained with IVUS	Procedural
Secondary	Stent sizing	Predicted stent diameter and length by 3DCT will be compared with the effectively implanted stent size	Procedural
Secondary	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
Secondary	Calcium modification	Prediction of calcium modification pre-IVUS compared with IVUS based strategy of calcium modification	Procedural
Secondary	Calcified lesions	Calcium score as determined by 3DCT will be correlated with the maximum calcium arc on IVUS	Procedural
Secondary	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