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

NCT ID: NCT01917682

Last Updated: 2020-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

754 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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robotic-assisted PCI coronary intervention CorPath PRECISION Registry PCI angioplasty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Study Cohort

Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI)

CorPath-assisted Percutaneous Coronary Intervention

Intervention Type PROCEDURE

Robotic-assisted Percutaneous Coronary Intervention

Interventions

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CorPath-assisted Percutaneous Coronary Intervention

Robotic-assisted Percutaneous Coronary Intervention

Intervention Type PROCEDURE

Other Intervention Names

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Robotic-assisted Percutaneous Coronary Intervention

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corindus Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giora Weisz, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University Medical Center/New York-Presbyterian Hospital

Chris Cain

Role: STUDY_DIRECTOR

VP, Clinical Affairs

Locations

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UC San Diego Medical Center

San Diego, California, United States

Site Status

Valley View Hospital

Glenwood Springs, Colorado, United States

Site Status

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Orlando Regional Medical Center

Orlando, Florida, United States

Site Status

North Georgia Heart Foundation

Gainesville, Georgia, United States

Site Status

St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Site Status

Spectrum Health System

Grand Rapids, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Columbia University Medical Center/New York-Presbyterian Hospital

New York, New York, United States

Site Status

St. Joseph's Hospital Health Center

Syracuse, New York, United States

Site Status

Carolinas Medical Center - Northeast

Concord, North Carolina, United States

Site Status

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

Sanford Health

Sioux Falls, South Dakota, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Virginia Commonwealth Univ. Medical Center

Richmond, Virginia, United States

Site Status

Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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United States Israel

Other Identifiers

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PRECISION CorPath Registry

Identifier Type: -

Identifier Source: org_study_id