Registry evaluating robotically assisted heart procedures
Multicenter Registry on Robotically Assisted Percutaneous Coronary Interventions - TESLA Registry
Clinical Research Center, Intercard Sp. z o.o. · NCT05841745
This study is testing how safe and effective robot-assisted heart procedures are for people with heart conditions like stable coronary artery disease or recent heart attacks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinical Research Center, Intercard Sp. z o.o. (industry) |
| Drugs / interventions | radiation |
| Locations | 6 sites (Aalst and 5 other locations) |
| Trial ID | NCT05841745 on ClinicalTrials.gov |
What this trial studies
The TESLA registry is a multicenter observational study assessing the safety and efficacy of robotically assisted percutaneous coronary interventions (PCI) using the CorPath GRX System in real-world clinical settings. This registry aims to collect data from patients who have undergone R-PCI, focusing on those with stable coronary artery disease, unstable angina, or acute myocardial infarction. By analyzing baseline, procedural, and follow-up data, the study seeks to provide insights into the effectiveness and safety of this innovative approach in interventional cardiology. The goal is to enroll between 700 to 1000 patients across various international centers.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with stable coronary artery disease, unstable angina, or acute myocardial infarction who are suitable for R-PCI.
Not a fit: Patients who are unwilling to provide informed consent or do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of PCI procedures for patients with coronary artery disease.
How similar studies have performed: Previous studies have shown promising results with robotically assisted PCI, indicating a potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Older than 18 years, * Patients with either stable coronary artery disease, unstable angina, or acute myocardial infarction (MI), * Coronary artery lesions considered suitable for R-PCI with CorPath GRX System. Exclusion Criteria: \- Unwillingness to provide informed consent (only if applicable).
Where this trial is running
Aalst and 5 other locations
- Hartcentrum OLV Aalst — Aalst, Belgium (COMPLETED)
- SEGEBERGER Kliniken GmbH — Bad Segeberg, Germany (COMPLETED)
- Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany (COMPLETED)
- Sapporo Cardiovascular Clinic — Sapporo, Japan (COMPLETED)
- Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii — Nowy Sącz, Malopolska, Poland (RECRUITING)
- Hospital Gregorio Maranon — Madrid, Spain (COMPLETED)
Study contacts
- Principal investigator: Dariusz Dudek, MD, PhD — Clinical Research Center Intercard
- Study coordinator: Adriana Zlahoda-Huzior, MSc
- Email: azlahoda@carint.pl
- Phone: +48788624993
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Robotically-assisted percutaneous coronary intervention, Coronary artery disease, R-PCI registry