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

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: Completed
• Conditions: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Artery Disease; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases
• Intervention / Treatment: Procedure: CorPath-assisted Percutaneous Coronary Intervention

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: Observational
• Enrollment (Actual): 754

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Success	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

Outcome Measure	Measure Description	Time Frame
Number of Participants With In-hospital Major Adverse Coronary Events (MACE)	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	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

Outcome Measure	Measure Description	Time Frame
Overall Procedure Time	Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.	During procedure
PCI Procedure Time	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	As recorded by an X-Ray System utilized during the procedure.	During procedure
Contrast Fluid Volume	The amount of contrast fluid used (mL) during the procedure.	During procedure
Patient Radiation Exposure - Dose-Area-Product	DAP (dose-area-product) as recorded during the procedure.	During procedure
Patient Radiation Exposure - Cumulative Dose	Cumulative dose (mGy) as recored during the procedure.	During procedure
Number of Participants Who Had a Conversions to Manual Technique.	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	Visual estimate by clinical operator prior to delivery of PCI device(s).	During procedure
CorPath Measurement of Lesion Length	Robotic measurement of lesion length using the CorPath System performed by the Clinical Operator.	During procedure

Collaborators and Investigators

• Sponsor: Corindus Inc.
• Investigators: Principal Investigator: Giora Weisz, MD, Columbia University Medical Center/New York-Presbyterian Hospital; Study Director: Chris Cain, VP, Clinical Affairs

Publications and helpful links

Helpful Links

• Visit the Corindus website for related information.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: August 2, 2013
• First Submitted That Met QC Criteria: August 5, 2013
• First Posted (Estimate): August 7, 2013

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: PCI; angioplasty; coronary intervention; robotic-assisted PCI; CorPath PRECISION Registry
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Vascular Diseases; Ischemia; Arterial Occlusive Diseases; Arteriosclerosis
• Other Study ID Numbers: PRECISION CorPath Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No