Coronary CT Angiography for Guiding Percutaneous Coronary Artery Intervention: a Prospective Randomised Study

Not Applicable

Recruiting

• Conditions: I25; Chronic ischaemic heart disease

• Registration Number: DRKS00028994
• Lead Sponsor: niversitätsklinikum Erlangen Medizinische Klinik 2

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1.Subjects must be at least 18 years of age.
2.Available coronary CT angiography data set
3.Obstructive coronary artery disease with at least one lesion causing > 50% stenosis in a coronary segment planned for percutaneous revascularisation according to clinical decision making.
4.Evidence of myocardial ischemia e.g. stable angina, silent ischemia, unstable angina suitable for elective PCI.
5.Good CT image quality with absence of artefacts in the affected coronary segment
6.No more than 2 target lesions requiring PCI are present in any single vessel, and no more than 2 target vessels are allowed. (PCI to non-target vessels are allowed after 48 hours of index PCI).
7.The patient signing a written informed consent.

Exclusion Criteria

1. Age >85 years
2. Target lesion location in a previously revascularized segment (stents or coronary artery bypass grafting)
3. Left main coronary artery stenosis
4. Patients with status post complicated PCI
5. Cardiogenic shock or hemodynamic instability
6. Creatinine clearance < 30 ml/l/min/1.73 m² as calculated by MDRD formula and not on dialysis.
7. Left ventricular ejection fraction < 30%
8. Planned cardiac or non-cardiac surgery within 24 months after index procedure
9. Prior PCI within the target vessel(s) within 12 months.
10. Any prior PCI in a non-target vessel within 24 hours before study or within 30 days if unsuccessful or complicated.
11. Planned use of a stent < 2.5 mm in diameter
12. Ostial left main stenosis or ostial RCA stenosis
13. Patients with chronic renal insufficiency with GFR < 30 ml/min/1.73 m²
14. Patients actively participating in another study without completion of the primary endpoint or follow-up period.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is ‘optimal stent deployment’ which is a composite technical endpoint defined as: a) absence of malapposition, b) stent expansion = 80% and c) absence of edge dissections.