On-Site Augmented-Reality Computed Tomography Plus Angiography versus Angiography Alone for Guiding Percutaneous Coronary Intervention in Native Coronary Lesions * Randomized Study.

On-Site Augmented-Reality Computed Tomography Plus Angiography versus Angiography Alone for Guiding Percutaneous Coronary Intervention in Native Coronary Lesions * Randomized Study. - AR-PCI trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48988

Enrollment

Registered

2018-03-22

Start date

2018-04-25

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis coronary artery disease

Interventions

Patients will be randomized in a 1:1 fashion to angiographically plus CTA-assisted PCI or to angiographically-guided PCI only

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients with documented obstructive CAD defined as the presence of at least 1 stenosis *70% in a native coronary artery in whom PCI is considered based on clinical grounds

Exclusion criteria

Exclusion criteria: - refusal or inability to provide written informed consent - subjects in whom the quality of coronary CTA is low - bifurcation lesions, by which strategies other than a single cross-over stent technique are anticipated (i.e., side branch diameter *2.5 mm) - left main coronary artery stenosis - chronic total occlusions (excluding subtotal stenoses) - in-stent restenosis - chronic renal failure (estimated glomerular filtration rate

Design outcomes

Primary

Measure	Time frame
(1) length of the stented segment and (2) predicted stent diameter according to a compliance chart. To reduce bias, all study endpoints will be collected in a blinded fashion with respect to group allocation as well as patients* clinical and tomographic characteristics.	—

Secondary

Measure	Time frame
- nominal stent diameter - number of stents - predilation - postdilation - maximal balloon pressure - maximal balloon diameter - total procedural time - total fluoroscopy time - total radiation dose - total contrast load - procedural complications (including death, myocardial infarction, stroke, transient ischemic attack, need for urgent CABG, pericardial tamponade, contrast-induced nephropathy, stent-edge dissection, dissection length) - post-procedural residual diameter stenosis using 3D QCA - post-procedural residual area stenosis using 3D QCA - post-procedural minimum lumen diameter using 3D QCA - post-procedural minimum lumen area using 3D QCA - post-procedural lumen diameters at proximal and distal reference segments using 3D QCA - post-procedural lumen areas at proximal and distal reference segments using 3D QCA - post-procedural volume of the stented segment using 3D QCA - post-procedural volume of the reference segments using 3D QCA To reduce bias, all study endpoints will be collected in a blinded fashion with respect to group allocation as well as patients* clinical and tomographic characteristics.	—

Measure

Time frame

- nominal stent diameter - number of stents - predilation - postdilation - maximal balloon pressure - maximal balloon diameter - total procedural time - total fluoroscopy time - total radiation dose - total contrast load - procedural complications (including death, myocardial infarction, stroke, transient ischemic attack, need for urgent CABG, pericardial tamponade, contrast-induced nephropathy, stent-edge dissection, dissection length) - post-procedural residual diameter stenosis using 3D QCA - post-procedural residual area stenosis using 3D QCA - post-procedural minimum lumen diameter using 3D QCA - post-procedural minimum lumen area using 3D QCA - post-procedural lumen diameters at proximal and distal reference segments using 3D QCA - post-procedural lumen areas at proximal and distal reference segments using 3D QCA - post-procedural volume of the stented segment using 3D QCA - post-procedural volume of the reference segments using 3D QCA To reduce bias, all study endpoints will be collected in a blinded fashion with respect to group allocation as well as patients* clinical and tomographic characteristics.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)