Trials / Completed
CompletedNCT05172323
Pre-procedural 3DCT Versus Angiography Guided PCI for Ostial Right Coronary Artery Lesions
Pre-procedural 3D Reconstructed Computer Tomography Versus Angiography Guided Percutaneous Coronary Intervention for Ostial Right Coronary Artery Lesions
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Ziekenhuis Oost-Limburg · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
| OTHER | 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. |
Timeline
- Start date
- 2022-01-13
- Primary completion
- 2023-02-08
- Completion
- 2023-02-08
- First posted
- 2021-12-29
- Last updated
- 2023-03-29
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT05172323. Inclusion in this directory is not an endorsement.