Multicenter Registry on Robotically Assisted PCI - TESLA

Clinical Research Center, Intercard Sp. z o.o.

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Device: Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX System

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05841745

TESLA Protocol Version 2.1

Details and patient eligibility

About

MulTicenter rEgiStry on RoboticalLy Assisted percutaneous coronary interventions- TESLA registry is a retrospective registry evaluating the safety and efficacy of robotically assisted PCI with the CorPath GRX System (Corindus Vascular, Siemens Healthineers, Germany) in real-world interventional cardiology practice.

Full description

R-PCI represents a novel approach to performing PCI with several studies showing high technical success and low complication rates. The CorPath GRX System is the second generation of the CorPath platform, dedicated to advancing robotic-assisted vascular procedures to mitigate the orthopaedic and radiation-related occupational hazards associated with the practice of interventional cardiology.

MulTicenter rEgiStry on RoboticalLy Assisted percutaneous coronary interventions- TESLA registry is a retrospective registry evaluating the safety and efficacy of robotically assisted PCI with the CorPath GRX System (Siemens Healthineers, Germany) in real-world interventional cardiology practice in Europe and Asia.

All patients who underwent R-PCI (defined as completion of at least one procedural step robotically) with the CorPath GRX System and completed one-year follow-up are eligible for recruitment in this registry, if older than 18 years. This study includes patients with either stable coronary artery disease, unstable angina, or acute myocardial infarction (MI).

The Study Investigators expect to enroll at least 700 patients (up to 1000). International centers that performed R-PCI with the CorPath GRX System will be invited to participate in this multicenter study.

Baseline, procedural, and follow-up data will be collected for all cases.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

700 participants in 1 patient group

Robotically-Assisted Percutaneous Coronary Intervention

Description:

All patients older than 18 years, who underwent R-PCI (defined as completion of at least one procedural step robotically) with the CorPath GRX System (Corindus Vascular) and completed one-year follow-up including patients with either stable coronary artery disease, unstable angina, or acute myocardial infarction (MI).

Treatment:

Device: Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX System