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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
3DCT-scan
Angiography guided PCI
Sponsored by
Ziekenhuis Oost-Limburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Right coronary artery, Computed tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuis Oost-Limburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

3DCT-guided group

Angiography-guided group

Arm Description

PCI guided with 3DCT results and IVUS

PCI guided by operator and IVUS

Outcomes

Primary Outcome Measures

Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)
Distance between the aorta-ostial junction and the most proximal protruding stent strut (in mm).

Secondary Outcome Measures

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
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
Volume of contrast agent administered
Expressed in mL
Procedural radiation dose
Expressed in mGy
Procedural duration from first puncture of artery to skin closure
Expressed in minutes
Minimal luminal area (MLA)
The predicted MLA by 3DCT will be compared with the MLA prior to stent placement as obtained with IVUS
Stent sizing
Predicted stent diameter and length by 3DCT will be compared with the effectively implanted stent size
Stent expansion
Expressed as the minimal stent area (MSA) determined by IVUS, divided by the reference luminal area in the healthy distal landing zone
Calcium modification
Prediction of calcium modification pre-IVUS compared with IVUS based strategy of calcium modification
Calcified lesions
Calcium score as determined by 3DCT will be correlated with the maximum calcium arc on IVUS
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]

Full Information

First Posted
November 24, 2021
Last Updated
March 27, 2023
Sponsor
Ziekenhuis Oost-Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT05172323
Brief Title
Pre-procedural 3DCT Versus Angiography Guided PCI for Ostial Right Coronary Artery Lesions
Acronym
3DCT-RCA
Official Title
Pre-procedural 3D Reconstructed Computer Tomography Versus Angiography Guided Percutaneous Coronary Intervention for Ostial Right Coronary Artery Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
February 8, 2023 (Actual)
Study Completion Date
February 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziekenhuis Oost-Limburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Right coronary artery, Computed tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, investigator-initiated, single-centre, randomized-controlled, assessor blinded pilot trial.
Masking
Outcomes Assessor
Masking Description
The assessor of the IVUS images will be blinded to treatment arm
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3DCT-guided group
Arm Type
Experimental
Arm Description
PCI guided with 3DCT results and IVUS
Arm Title
Angiography-guided group
Arm Type
Placebo Comparator
Arm Description
PCI guided by operator and IVUS
Intervention Type
Device
Intervention Name(s)
3DCT-scan
Intervention Description
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
Other
Intervention Name(s)
Angiography guided PCI
Intervention Description
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 Outcome Measure Information:
Title
Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)
Description
Distance between the aorta-ostial junction and the most proximal protruding stent strut (in mm).
Time Frame
Procedural
Secondary Outcome Measure Information:
Title
Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)
Description
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
Time Frame
Procedural
Title
Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)
Description
The percentage of patients who need an additional stent after the final IVUS has shown that the ostium was not fully covered
Time Frame
Procedural
Title
Volume of contrast agent administered
Description
Expressed in mL
Time Frame
Procedural
Title
Procedural radiation dose
Description
Expressed in mGy
Time Frame
Procedural
Title
Procedural duration from first puncture of artery to skin closure
Description
Expressed in minutes
Time Frame
Procedural
Title
Minimal luminal area (MLA)
Description
The predicted MLA by 3DCT will be compared with the MLA prior to stent placement as obtained with IVUS
Time Frame
Procedural
Title
Stent sizing
Description
Predicted stent diameter and length by 3DCT will be compared with the effectively implanted stent size
Time Frame
Procedural
Title
Stent expansion
Description
Expressed as the minimal stent area (MSA) determined by IVUS, divided by the reference luminal area in the healthy distal landing zone
Time Frame
Procedural
Title
Calcium modification
Description
Prediction of calcium modification pre-IVUS compared with IVUS based strategy of calcium modification
Time Frame
Procedural
Title
Calcified lesions
Description
Calcium score as determined by 3DCT will be correlated with the maximum calcium arc on IVUS
Time Frame
Procedural
Title
MACCE at 30 days follow-up
Description
30 days event rate [death, non-fatal MI, non-fatal stroke, definite or probable stent thrombosis, target lesion failure]
Time Frame
30 days after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koen Ameloot, Dr.
Organizational Affiliation
Ziekenhuis Oost-Limburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
State/Province
Limburg
ZIP/Postal Code
3600
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
29407132
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.
Results Reference
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Pre-procedural 3DCT Versus Angiography Guided PCI for Ostial Right Coronary Artery Lesions

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