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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-13

Study Completion Date

2023-02-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The assessor of the IVUS images will be blinded to treatment arm

Study Groups

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3DCT-guided group

PCI guided with 3DCT results and IVUS

Group Type EXPERIMENTAL

3DCT-scan

Intervention Type 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.

Angiography-guided group

PCI guided by operator and IVUS

Group Type PLACEBO_COMPARATOR

Angiography guided PCI

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No