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

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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: 3DCT-scan; Other: Angiography guided PCI

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Ziekenhuis Oost-Limburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3DCT-guided group; PCI guided with 3DCT results and IVUS	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.
Placebo Comparator: Angiography-guided group; PCI guided by operator and IVUS	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg
• Investigators: Principal Investigator: Koen Ameloot, Dr., Ziekenhuis Oost-Limburg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2022
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): February 8, 2023

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: December 27, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Computed tomography; Right coronary artery
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Z-2021107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No