Multicenter Registry on Robotically Assisted PCI - TESLA

NCT05841745 | Recruiting FDA Device

• 1 other identifier: TESLA Protocol Version 2.1
• Study Type: observational
• Target: 700
• Locations: 5 countries
• Sites: 6

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.

Conditions

Coronary Artery Disease

Keywords

Robotically-assisted percutaneous coronary intervention; Coronary artery disease; R-PCI registry

Outcome Measures

Primary Outcomes (1)

• 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);

  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)

  1 year post-procedure

• Number of participants with target lesion failure (TLF)

  1 year post-procedure

• Number of participants with target vessel failure (TVF)

  1 year post-procedure

• Procedure time

  During the procedure

• Contrast volume

  During the procedure

Other Outcomes (4)

• Major adverse cardiovascular events (MACE)

  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

• Number of participants with stent thrombosis

  1 year post-procedure

• Bleeding events

  1 year post-procedure

Study Arms (1)

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).

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

Interventions

Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX System DEVICE

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.

Robotically-Assisted Percutaneous Coronary Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• \- Unwillingness to provide informed consent (only if applicable).

Sponsors & Collaborators

• Clinical Research Center, Intercard Sp. z o.o.: lead
• Corindus, Inc. dba Siemens Healthineers Endovascular Robotics: collaborator
• KCRI Sp. z o.o.: collaborator

Study Sites (6)

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, 33-300, Poland

RECRUITING

Hospital Gregorio Maranon

Madrid, Spain

COMPLETED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Dariusz Dudek, MD, PhD

  Clinical Research Center Intercard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriana Zlahoda-Huzior, MSc

CONTACT

+48788624993; azlahoda@carint.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 3, 2023
• Study Start: March 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: July 1, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1); ES (1); BE (1); DE (2); PL (1)