Coronary Artery Disease3DCT-RCANCT05172323
Pre-procedural 3DCT Versus Angiography Guided PCI for Ostial Right Coronary Artery Lesions
A study testing 3DCT-scan and Angiography guided PCI in people with Coronary Artery Disease, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- 3DCT-scan and Angiography guided PCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Jan 2022to 8 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-procedural 3D Reconstructed Computer Tomography Versus Angiography Guided Percutaneous Coronary Intervention 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.
- Conditions
- Coronary Artery Disease
- Being tested
- 3DCT-scan, Angiography guided PCI
- Keywords
- Right coronary artery, Computed tomography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DCT-scanDevice
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 PCIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 3DCT-guided group | Experimental | PCI guided with 3DCT results and IVUS Receives: Device: 3DCT-scan |
| Angiography-guided group | Placebo comparator | PCI guided by operator and IVUS Receives: Other: Angiography guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)
Distance between the aorta-ostial junction and the most proximal protruding stent strut (in mm).
Measured: Procedural
Secondary outcomes (11)
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
Measured: Procedural
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
Measured: Procedural
Volume of contrast agent administered
Expressed in mL
Measured: Procedural
Procedural radiation dose
Expressed in mGy
Measured: Procedural
Procedural duration from first puncture of artery to skin closure
Expressed in minutes
Measured: Procedural
Minimal luminal area (MLA)
The predicted MLA by 3DCT will be compared with the MLA prior to stent placement as obtained with IVUS
Measured: Procedural
Stent sizing
Predicted stent diameter and length by 3DCT will be compared with the effectively implanted stent size
Measured: Procedural
Stent expansion
Expressed as the minimal stent area (MSA) determined by IVUS, divided by the reference luminal area in the healthy distal landing zone
Measured: Procedural
Calcium modification
Prediction of calcium modification pre-IVUS compared with IVUS based strategy of calcium modification
Measured: Procedural
Calcified lesions
Calcium score as determined by 3DCT will be correlated with the maximum calcium arc on IVUS
Measured: Procedural
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]
Measured: 30 days after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start13 Jan 2022
- Primary completion8 Feb 2023
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, investigator-initiated, single-centre, randomized-controlled, assessor blinded pilot trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koen Ameloot, Ziekenhuis Oost-Limburg
- Investigators
- Koen Ameloot, Dr., Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172323
- Sponsor's protocol ID
- Z-2021107
- Acronym
- 3DCT-RCA
- Status last verified
- Mar 2023
- First submitted
- 24 Nov 2021
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29407132van 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.
PubMed 39878016
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-procedural 3D Reconstructed Computer Tomography Versus Angiography Guided Percutaneous Coronary Intervention for Ostial Right Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT05172323
- Acronym / sponsor ID
- 3DCT-RCA / Z-2021107
- Conditions
- Coronary Artery Disease
- Keywords
- Right coronary artery, Computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 8 Feb 2023 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, investigator-initiated, single-centre, randomized-controlled, assessor blinded pilot trial.
| Arm | Type | Receives |
|---|---|---|
| 3DCT-guided group | Experimental | Device: 3DCT-scanPCI guided with 3DCT results and IVUS |
| Angiography-guided group | Placebo comparator | Other: Angiography guided PCIPCI guided by operator and IVUS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3DCT-scanA 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. | Device | 3DCT-guided group |
| Angiography guided PCIStandard 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. | Other | Angiography-guided group |
Primary outcome
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).
11 secondary outcomes
Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)
Time frame: Procedural
Geographical mismatch as quantified by intra-coronary ultrasound (IVUS)
Time frame: Procedural
Volume of contrast agent administered
Time frame: Procedural
Procedural radiation dose
Time frame: Procedural
Procedural duration from first puncture of artery to skin closure
Time frame: Procedural
Minimal luminal area (MLA)
Time frame: Procedural
Stent sizing
Time frame: Procedural
Stent expansion
Time frame: Procedural
Calcium modification
Time frame: Procedural
Calcified lesions
Time frame: Procedural
MACCE at 30 days follow-up
Time frame: 30 days after PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Background: PubMed 29407132Mitomo 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.
- Derived from this study: PubMed 39878016van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Ameloot, Dr. principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3DCT-scan and Angiography guided PCI in people with Coronary Artery Disease, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geographical mismatch as quantified by intra-coronary ultrasound (IVUS) (time frame: Procedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05172323, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.