Coronary Artery DiseaseTESLANCT05841745
Multicenter Registry on Robotically Assisted PCI - TESLA
An observational study of Coronary Artery Disease, run by Clinical Research Center, Intercard Sp. z o.o. at 6 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX System
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 1 Mar 2023to Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Unwillingness to provide informed consent (only if applicable).
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Germany2 sites
- Completed
SEGEBERGER Kliniken GmbH
Bad Segeberg
- Completed
Universitätsklinikum Freiburg
Freiburg im Breisgau
Poland1 site, 1 recruiting
- Recruiting
Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii
Nowy Sącz, Malopolska, 33-300
Maria Kundzierewicz, MSc, m.kundzierewicz@intercard.net.pl
Aleksander Zelias, MD, PhD
About this study
Official title: Multicenter Registry on Robotically Assisted Percutaneous Coronary Interventions - TESLA Registry
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX System
- Keywords
- Robotically-assisted percutaneous coronary intervention, Coronary artery disease, R-PCI registry
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX SystemDevice
The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures. The CorPath GRX System is composed of two units; the first is a bedside unit which consists of the extended robotic arm, robotic drive, and single-use loading cassette, and the second is the remote workstation, which consists of the interventional cockpit and the control console. A key innovation of the CorPath GRX System is the software-based automation of common maneuvers, called technIQ automated movements with the potential to increase procedural success, reduce procedure time, and generally increase user comfort with robotic assistance during PCI.
| Study group | Role | What they receive |
|---|---|---|
| Robotically-Assisted Percutaneous Coronary Intervention | 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). Receives: Device: Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinically successful PCI
Clinical success, defined as angiographic success (residual stenosis after stenting of <30% with final TIMI [Thrombolysis In Myocardial Infarction] flow grade 3) without an in-hospital major adverse cardiovascular event (MACE) (death, target vessel MI, or need of repeat target vessel revascularization);
Measured: 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 (6)
Number of participants with ischemia-driven target lesion revascularization (TLR)
Ischemia-driven target lesion revascularization (TLR), at 1 year defined according to the Academic Research Consortium (ARC) criteria;
Measured: 1 year post-procedure
Number of participants with target lesion failure (TLF)
Target lesion failure (TLF) at 1 year, the composite of ARC-defined cardiac death, target vessel MI, or ischemia-driven TLR;
Measured: 1 year post-procedure
Number of participants with target vessel failure (TVF)
Target vessel failure (TVF) at 1 year, the composite of ARC-defined cardiac death, target vessel MI, or ischemia-driven TVR.
Measured: 1 year post-procedure
Procedure time
The time recorded from initial guidewire insertion into the robotic drive until guide catheter disengagement.
Measured: During the procedure
Contrast volume
The total contrast volume used during the procedure.
Measured: During the procedure
Patient radiation exposure
Dose-area-product (DAP) as recorded during the procedure.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Mar 2023
- Primary completion31 Dec 2023
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Research Center, Intercard Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Corindus, Inc. dba Siemens Healthineers Endovascular Robotics, KCRI Sp. z o.o.
- Responsible party
- Sponsor
- Investigators
- Dariusz Dudek, MD, PhD, Principal investigator, Clinical Research Center Intercard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841745
- Sponsor's protocol ID
- TESLA Protocol Version 2.1
- Acronym
- TESLA
- Status last verified
- Jul 2024
- First submitted
- 6 Apr 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Registry on Robotically Assisted Percutaneous Coronary Interventions - TESLA Registry
- ClinicalTrials.gov ID
- NCT05841745
- Acronym / sponsor ID
- TESLA / TESLA Protocol Version 2.1
- Conditions
- Coronary Artery Disease
- Keywords
- Robotically-assisted percutaneous coronary intervention, Coronary artery disease, R-PCI registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Clinical Research Center, Intercard Sp. z o.o.Industry (pharma, biotech, devices)
- Collaborators
- Corindus, Inc. dba Siemens Healthineers Endovascular Robotics, KCRI Sp. z o.o.
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- Jul 2024 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotically-Assisted Percutaneous Coronary Intervention | – | Device: Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX SystemAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Unwillingness to provide informed consent (only if applicable).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX SystemThe CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures. The CorPath GRX System is composed of two units; the first is a bedside unit which consists of the extended robotic arm, robotic drive, and single-use loading cassette, and the second is the remote workstation, which consists of the interventional cockpit and the control console. A key innovation of the CorPath GRX System is the software-based automation of common maneuvers, called technIQ automated movements with the potential to increase procedural success, reduce procedure time, and generally increase user comfort with robotic assistance during PCI. | Device | Robotically-Assisted Percutaneous Coronary Intervention |
Primary outcome
Number of participants with clinically successful PCI
Time frame: 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
Clinical success, defined as angiographic success (residual stenosis after stenting of <30% with final TIMI [Thrombolysis In Myocardial Infarction] flow grade 3) without an in-hospital major adverse cardiovascular event (MACE) (death, target vessel MI, or need of repeat target vessel revascularization);
6 secondary outcomes
Number of participants with ischemia-driven target lesion revascularization (TLR)
Time frame: 1 year post-procedure
Number of participants with target lesion failure (TLF)
Time frame: 1 year post-procedure
Number of participants with target vessel failure (TVF)
Time frame: 1 year post-procedure
Procedure time
Time frame: During the procedure
Contrast volume
Time frame: During the procedure
Patient radiation exposure
Time frame: During the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dariusz Dudek, MD, PhD principal investigator
Clinical Research Center Intercard
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Clinical Research Center, Intercard Sp. z o.o. at 6 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Belgium, Japan, Poland, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adriana Zlahoda-Huzior, MSc (+48788624993, azlahoda@carint.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with clinically successful PCI (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.