Clinical trial NCT05841745: Multicenter Registry on Robotically Assisted PCI - TESLA
Official title: Multicenter Registry on Robotically Assisted Percutaneous Coronary Interventions - TESLA Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Robotically-assisted percutaneous coronary intervention
Coronary artery disease
R-PCI registry
Lead sponsor: Clinical Research Center, Intercard Sp. z o.o.
Sponsor class: INDUSTRY
Collaborators: name: Corindus, Inc. dba Siemens Healthineers Endovascular Robotics
name: KCRI Sp. z o.o.
First posted: 2023-05-03
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This registry will include at least 700 patients (up to 1000) who underwent R-PCI. All the international centers that have already utilized the CorPath GRX System have been invited to participate in this multicenter study. The final number of patients enrolled in the study will depend on the final number of participating centers and the number of patients treated with R-PCI with CorPath GRX System in each center. All patients 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 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).

Brief summary: 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.

Detailed 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.

Eligibility 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).

Primary outcomes:
measure: Number of participants with clinically successful PCI
timeFrame: From time of procedure until date of first event or death from any cause, which came first, assessed up to the time of discharge in the index hospitalization
Secondary outcomes:
measure: Number of participants with ischemia-driven target lesion revascularization (TLR)
timeFrame: 1 year post-procedure
measure: Number of participants with target lesion failure (TLF)
timeFrame: 1 year post-procedure
measure: Number of participants with target vessel failure (TVF)
timeFrame: 1 year post-procedure
measure: Procedure time
timeFrame: During the procedure
measure: Contrast volume
timeFrame: During the procedure
measure: Patient radiation exposure
timeFrame: During the procedure
Other outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: From time of procedure until date of first event or death from any cause, which came first, assessed up to the time of discharge in the index hospitalization
measure: Number of participants with stent thrombosis
timeFrame: 1 year post-procedure
measure: Bleeding events
timeFrame: 1 year post-procedure
measure: Manual input and/or conversion
timeFrame: During the procedure
Locations:
city: Aalst
country: Belgium
facility: Hartcentrum OLV Aalst
city: Bad Segeberg
country: Germany
facility: SEGEBERGER Kliniken GmbH
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Sapporo
country: Japan
facility: Sapporo Cardiovascular Clinic
city: Nowy Sacz
country: Poland
facility: Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii
state: Malopolska
city: Madrid
country: Spain
facility: Hospital Gregorio Maranon
Study officials:
affiliation: Clinical Research Center Intercard
name: Dariusz Dudek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: