Freiburg Robotics in Interventional Cardiology Registry

Recruiting

• Conditions: I25; I21; Acute myocardial infarction; Chronic ischaemic heart disease

• Registration Number: DRKS00023868
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Adult patients
- Informed consent
- Robotics assisted PCI

Exclusion Criteria

- Refusal by patients

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Successful coronary intervention (PCI) (%)<br>- Procedural characteristics <br>o Pre- and post-procedure time (min)<br>o Procedure duration (incision-suture time) (min)<br>- Diagnostic (min) and intervention (min)<br>o Amount of contrast medium (ml)<br>o Fluoroscopy time (min)<br>- Diagnostics (min) and intervention (min)<br>o Radiation dose for physician (Dose-area product (cGycm²))<br>o Radiation dose for patient (Dose-area product (cGycm²) <br>o Recording of periprocedural complications (%)<br>- Myocardial infarction (%)<br>- MACE (major adverse cardiovascular events) (%)<br>- Stent thrombosis (%)<br>- dissection (%)<br>- Target vessel revascularization (%)<br>o Evolution of intervention rate (min)<br>o Proportion of manual assistance required (%)

Secondary Outcome Measures

Name	Time	Method
- Mortality<br>- Long-term assessment of intervention success<br>o Death (%), cardiovascular death (%), and time to death (m).<br>o Rehospitalization rate (%)<br>o Need for reintervention (%)<br>o Target vessel failure (%) and time to failure (m)<br>o Health-related quality of life survey <br>- NYHA score <br>- Canadian Cardiovascular Society (CCS) Angina Grade <br>- EuroQoL 5D (EQ-5D-5L) <br>- Seattle angina questionnaire - 7 short form (SAQ-7)