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OpenTrials
Completed

NCT Number: NCT01917682

Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions

To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath 200 System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters during PCI procedures.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shaare Zedek Medical Center, Jerusalem, Israel

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About this study

This is a prospective, single-arm, open-label, multi-center patient registry of the CorPath 200 System to examine its performance during PCI procedure and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years.
  • Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI) with the CorPath 200 system.
  • The subject or the legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion criteria

  • Concurrent enrollment in another device or drug study protocol that specifically excludes concurrent enrollment or that prevents collection of data required in this registry (concurrent participation in another registry is not an automatic exclusion criterion for this study).
  • Failure/inability/unwillingness to provide informed consent.

Treatment and study plan

CorPath-assisted Percutaneous Coronary Intervention

Procedure

Robotic-assisted Percutaneous Coronary Intervention

Other names: Robotic-assisted Percutaneous Coronary Intervention

Primary outcomes

  1. Number of Participants With Clinical Success

    Time frame: In-hospital (72-hours or discharge, whichever occurs first)

    Less than 30% residual stenosis post PCI in the lesion(s) treated with the CorPath system, without in-hospital major adverse coronary events (MACE).

Secondary outcomes

  1. Number of Participants With In-hospital Major Adverse Coronary Events (MACE)

    Time frame: In-hospital (72-hours or discharge, whichever occurs first)

    The composite of death, myocardial infarction, and target vessel revascularization that occurs within 72 hours of the procedure or prior to hospital discharge, whichever occurs first, in a subject treated with the CorPath 200 System.

  2. Number of Participants With an Adverse Event

    Time frame: In-hospital (72-hours or discharge, whichever occurs first)

    All Serious Adverse Events (SAEs) and Unanticipated Adverse Device Effects (UADEs) from the start of the CorPath procedure until the end of the study will be summarized.

Other outcomes

  1. Overall Procedure Time

    Time frame: During procedure

    Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.

  2. PCI Procedure Time

    Time frame: During procedure

    Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.

  3. Fluoroscopy and/or X-Ray Time

    Time frame: During procedure

    As recorded by an X-Ray System utilized during the procedure.

  4. Contrast Fluid Volume

    Time frame: During procedure

    The amount of contrast fluid used (mL) during the procedure.

  5. Patient Radiation Exposure - Dose-Area-Product

    Time frame: During procedure

    DAP (dose-area-product) as recorded during the procedure.

  6. Patient Radiation Exposure - Cumulative Dose

    Time frame: During procedure

    Cumulative dose (mGy) as recored during the procedure.

  7. Number of Participants Who Had a Conversions to Manual Technique.

    Time frame: During procedure

    The overall number of conversions from the robotic PCI to manual PCI will be captured to analyze the technical success of the device.

  8. Visual Measurement of Lesion Length

    Time frame: During procedure

    Visual estimate by clinical operator prior to delivery of PCI device(s).

  9. CorPath Measurement of Lesion Length

    Time frame: During procedure

    Robotic measurement of lesion length using the CorPath System performed by the Clinical Operator.

Sponsors and collaborators

Lead sponsor

Siemens Healthineers Endovascular Robotics, Inc.

Industry

Registry information

Official study title

A Post-Market Registry for the Evaluation of the CorPath 200 System Effectiveness in Percutaneous Coronary Interventions

Acronym: PRECISION

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 7, 2013
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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