Multicenter Registry on Robotically Assisted PCI - TESLA

Last updated: July 10, 2024
Sponsor: Clinical Research Center, Intercard Sp. z o.o.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Thrombosis

Chest Pain

Treatment

Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX System

Clinical Study ID

NCT05841745
TESLA Protocol Version 2.1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Older than 18 years,

  • Patients with either stable coronary artery disease, unstable angina, or acutemyocardial infarction (MI),

  • Coronary artery lesions considered suitable for R-PCI with CorPath GRX System.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 700
Treatment Group(s): 1
Primary Treatment: Robotically-Assisted Percutaneous Coronary Intervention with CorPath GRX System
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
July 31, 2024

Study 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.

Connect with a study center

  • Hartcentrum OLV Aalst

    Aalst,
    Belgium

    Completed

  • SEGEBERGER Kliniken GmbH

    Bad Segeberg,
    Germany

    Completed

  • Universitätsklinikum Freiburg

    Freiburg,
    Germany

    Completed

  • Sapporo Cardiovascular Clinic

    Sapporo,
    Japan

    Completed

  • Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii

    Nowy Sacz, Malopolska 33-300
    Poland

    Active - Recruiting

  • Hospital Gregorio Maranon

    Madrid,
    Spain

    Completed

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