Clinical trial NCT05172323: Pre-procedural 3DCT Versus Angiography Guided PCI for Ostial Right Coronary Artery Lesions
Official title: Pre-procedural 3D Reconstructed Computer Tomography Versus Angiography Guided Percutaneous Coronary Intervention for Ostial Right Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Right coronary artery
Computed tomography
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, investigator-initiated, single-centre, randomized-controlled, assessor blinded pilot trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)
timeFrame: Procedural
Secondary outcomes:
measure: Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)
timeFrame: Procedural
measure: Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)
timeFrame: Procedural
measure: Volume of contrast agent administered
timeFrame: Procedural
measure: Procedural radiation dose
timeFrame: Procedural
measure: Procedural duration from first puncture of artery to skin closure
timeFrame: Procedural
measure: Minimal luminal area (MLA)
timeFrame: Procedural
measure: Stent sizing
timeFrame: Procedural
measure: Stent expansion
timeFrame: Procedural
measure: Calcium modification
timeFrame: Procedural
measure: Calcified lesions
timeFrame: Procedural
measure: MACCE at 30 days follow-up
timeFrame: 30 days after PCI
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Koen Ameloot, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.