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Completed

NCT Number: NCT05172323

Pre-procedural 3DCT Versus Angiography Guided PCI 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Procedural

    Distance between the aorta-ostial junction and the most proximal protruding stent strut (in mm).

Secondary outcomes

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

    Time frame: Procedural

    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

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

    Time frame: Procedural

    The percentage of patients who need an additional stent after the final IVUS has shown that the ostium was not fully covered

  3. Volume of contrast agent administered

    Time frame: Procedural

    Expressed in mL

  4. Procedural radiation dose

    Time frame: Procedural

    Expressed in mGy

  5. Procedural duration from first puncture of artery to skin closure

    Time frame: Procedural

    Expressed in minutes

  6. Minimal luminal area (MLA)

    Time frame: Procedural

    The predicted MLA by 3DCT will be compared with the MLA prior to stent placement as obtained with IVUS

  7. Stent sizing

    Time frame: Procedural

    Predicted stent diameter and length by 3DCT will be compared with the effectively implanted stent size

  8. Stent expansion

    Time frame: Procedural

    Expressed as the minimal stent area (MSA) determined by IVUS, divided by the reference luminal area in the healthy distal landing zone

  9. Calcium modification

    Time frame: Procedural

    Prediction of calcium modification pre-IVUS compared with IVUS based strategy of calcium modification

  10. Calcified lesions

    Time frame: Procedural

    Calcium score as determined by 3DCT will be correlated with the maximum calcium arc on IVUS

  11. MACCE at 30 days follow-up

    Time frame: 30 days after PCI

    30 days event rate [death, non-fatal MI, non-fatal stroke, definite or probable stent thrombosis, target lesion failure]

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Official study title

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

Acronym: 3DCT-RCA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 29, 2021
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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