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

NCT05172323 | Completed

• 1 other identifier: Z-2021107
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Right coronary artery; Computed tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)

  Procedural

• Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)

  Procedural

• Volume of contrast agent administered

  Procedural

• Procedural radiation dose

  Procedural

• Procedural duration from first puncture of artery to skin closure

  Procedural

Study Arms (2)

3DCT-guided group

EXPERIMENTAL

PCI guided with 3DCT results and IVUS

Device: 3DCT-scan

Angiography-guided group

PLACEBO COMPARATOR

PCI guided by operator and IVUS

Other: Angiography guided PCI

Interventions

3DCT-scan DEVICE

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.

3DCT-guided group

Angiography guided PCI OTHER

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.

Angiography-guided group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Related Publications (2)

• 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.

  PMID: 29407132 BACKGROUND

• van den Buijs DMF, Poels EM, Willems E, Cottens D, Dotremont K, De Leener K, Meekers E, Ferdinande B, Vrolix M, Dens J, Ameloot K. Three-Dimensional CT for Preprocedural Planning of PCI for Ostial Right Coronary Artery Lesions: A Randomized Controlled Pilot Trial. Circ Cardiovasc Interv. 2025 Feb;18(2):e013584. doi: 10.1161/CIRCINTERVENTIONS.123.013584. Epub 2025 Jan 29.

  PMID: 39878016 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Koen Ameloot, Dr.

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor of the IVUS images will be blinded to treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional cardiologist

Model Details: A prospective, investigator-initiated, single-centre, randomized-controlled, assessor blinded pilot trial.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 29, 2021
• Study Start: January 13, 2022
• Primary Completion: February 8, 2023
• Study Completion: February 8, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

BE (1)