I25
Conditions
Interventions
Group 1: 1.) Evaluation of individualized coronary anatomy and physiology by
SyncVision, guided by the roboter
2.) Based on SyncVision results, plan and perform a robotic-assisted PCI
3.) Perform post
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. = 18 years 2. CCS, NSTE-ACS with hemodynamically and clinical stability 3. Single or multi-vessel CAD 4. prePCI-iFR of =0.89 with at least 1 stenosis 5. Informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Feasibility and success rate (%) of a combined procedure using SyncVision and R-PCI 2.Safety (MACE: cardiac death, cerebrovascular event (stroke), documented myocardial infarction, target lesion repeated revascularization (PCI and/or CABG); dissection, occlusion) (%) 3.Necessary manual assistance (%) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of stent implantation accuracy o postPCI-iFR (absolute), as assessed by SyncVision o postPCI-iFR <0.95 (%), as assessed by SyncVision o Intravascular ultrasound (IVUS), if postPCI-iFR =0.89 2. Ratio of iFR prePCI to postPCI | — |
Countries
Germany
Contacts
Public ContactConstantin von zur Mühlen
Universitätsklinikum Freiburg
Outcome results
None listed