Feasibility and precision of optical coherence tomography guided and robotic-assisted PCI

Recruiting

• Conditions: I20; Angina pectoris

• Registration Number: DRKS00024995
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. = 18 years
2. Patients undergoing planned stent implantation during a clinically indicated PCI procedure
3. All target lesions must have a visually estimated or quantitatively assessed %DS of either
=70%, or =50% plus one or more of the following: an abnormal functional test (e.g. fractional
flow reserve, stress test) signifying ischemia in the distribution of the target lesion(s) or
biomarker positive ACS with plaque disruption or thrombus.
4. Single or multi-vessel CAD
5. Informed consent

Exclusion Criteria

1. STE-ACS within the last 7 days
2. Unstable NSTE-ACS patients
3. Previous coronary artery bypass graft (CABG)
4. Chronic total occlusion (CTO)
5. Cardiogenic shock (sustained (>10 min) systolic blood pressure < 90 mmHg)
6. Persistent ventricular arrhythmia

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint<br>1.Success rate of OCT guided R-PCI (%) <br>2.Precision of R-PCI as determined by deviation from optimal stent landing zone (distal or proximal) (mm)