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

December 1, 2020 updated by: Corindus Inc.

A Post-Market Registry for the Evaluation of the CorPath 200 System Effectiveness 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
754

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
  • United States
    • California
      • San Diego, California, United States, 92103
        • UC San Diego Medical Center
    • Colorado
      • Glenwood Springs, Colorado, United States, 81601
        • Valley View Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Orlando, Florida, United States, 32806
        • Orlando Regional Medical Center
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • North Georgia Heart Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • St. Elizabeth's Medical Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health System
    • Minnesota
      • Rochester, Minnesota, United States, 55906
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center/New York-Presbyterian Hospital
      • Syracuse, New York, United States, 13203
        • St. Joseph's Hospital Health Center
    • North Carolina
      • Concord, North Carolina, United States, 28203
        • Carolinas Medical Center - Northeast
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Health
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth Univ. Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with coronary artery disease and with the clinical indication for Percutaneous Coronary Intervention (PCI).

Description

Inclusion Criteria:

  1. Age >18 years.
  2. Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI) with the CorPath 200 system.
  3. 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:

  1. 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).
  2. Failure/inability/unwillingness to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Study Cohort
Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI)
Procedure: CorPath-assisted Percutaneous Coronary Intervention
Robotic-assisted Percutaneous Coronary Intervention
Other Names:
  • Robotic-assisted Percutaneous Coronary Intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
In-hospital (72-hours or discharge, whichever occurs first)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
In-hospital (72-hours or discharge, whichever occurs first)
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.
In-hospital (72-hours or discharge, whichever occurs first)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
During procedure
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.
During procedure
Fluoroscopy and/or X-Ray Time
Time Frame: During procedure
As recorded by an X-Ray System utilized during the procedure.
During procedure
Contrast Fluid Volume
Time Frame: During procedure
The amount of contrast fluid used (mL) during the procedure.
During procedure
Patient Radiation Exposure - Dose-Area-Product
Time Frame: During procedure
DAP (dose-area-product) as recorded during the procedure.
During procedure
Patient Radiation Exposure - Cumulative Dose
Time Frame: During procedure
Cumulative dose (mGy) as recored during the procedure.
During procedure
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.
During procedure
Visual Measurement of Lesion Length
Time Frame: During procedure
Visual estimate by clinical operator prior to delivery of PCI device(s).
During procedure
CorPath Measurement of Lesion Length
Time Frame: During procedure
Robotic measurement of lesion length using the CorPath System performed by the Clinical Operator.
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Corindus Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giora Weisz, MD, Columbia University Medical Center/New York-Presbyterian Hospital
  • Study Director: Chris Cain, VP, Clinical Affairs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRECISION CorPath Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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