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

E

East Limburg Hospital

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: 3DCT-scan
Other: Angiography guided PCI

Study type

Interventional

Funder types

Other

Identifiers

NCT05172323
Z-2021107

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups, including a placebo group

3DCT-guided group
Experimental group
Description:
PCI guided with 3DCT results and IVUS
Treatment:
Device: 3DCT-scan
Angiography-guided group
Placebo Comparator group
Description:
PCI guided by operator and IVUS
Treatment:
Other: Angiography guided PCI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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