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

NCT01917682 | Completed Results

• 1 other identifier: PRECISION CorPath Registry
• Study Type: observational
• Target: 754
• Locations: 2 countries
• Sites: 16

Brief Summary

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.

Conditions

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

Keywords

robotic-assisted PCI; coronary intervention; CorPath PRECISION Registry; PCI; angioplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

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

• Number of Participants With an Adverse Event

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

Other Outcomes (9)

• Overall Procedure Time

  During procedure

• PCI Procedure Time

  During procedure

• Fluoroscopy and/or X-Ray Time

  During procedure

Study Arms (1)

Study Cohort

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

Procedure: CorPath-assisted Percutaneous Coronary Intervention

Interventions

CorPath-assisted Percutaneous Coronary Intervention PROCEDURE

Robotic-assisted Percutaneous Coronary Intervention

Also known as: Robotic-assisted Percutaneous Coronary Intervention

Study Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Failure/inability/unwillingness to provide informed consent.

Sponsors & Collaborators

• Corindus Inc.: lead

Study Sites (16)

UC San Diego Medical Center

San Diego, California, 92103, United States

Location

Valley View Hospital

Glenwood Springs, Colorado, 81601, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

North Georgia Heart Foundation

Gainesville, Georgia, 30501, United States

Location

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Spectrum Health System

Grand Rapids, Michigan, 49503, United States

Location

Mayo Clinic

Rochester, Minnesota, 55906, United States

Location

Columbia University Medical Center/New York-Presbyterian Hospital

New York, New York, 10032, United States

Location

St. Joseph's Hospital Health Center

Syracuse, New York, 13203, United States

Location

Carolinas Medical Center - Northeast

Concord, North Carolina, 28203, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57104, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Virginia Commonwealth Univ. Medical Center

Richmond, Virginia, 23298, United States

Location

Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Location

MeSH Terms

Conditions

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

Results Point of Contact

• Title: John Van Vleet, VP of Clinical and Regulatory Affairs
• Organization: Corindus, Inc.

john.van_vleet@siemens-healthineers.com

(260)615-8892

Study Officials

• Giora Weisz, MD

  Columbia University Medical Center/New York-Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

• Chris Cain

  VP, Clinical Affairs

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 7, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 22, 2020
• Results First Posted: December 2, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (15)