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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corindus Inc.
ClinicalTrials.gov Identifier:
NCT01917682
First received: August 2, 2013
Last updated: June 9, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Procedure: CorPath-assisted Percutaneous Coronary Intervention

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 3 Days
Official Title: A Post-Market Registry for the Evaluation of the CorPath 200 System Effectiveness in Percutaneous Coronary Interventions

Further study details as provided by Corindus Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • Adverse Events [ 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 Outcome Measures:
  • 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.

  • 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.

  • Fluoroscopy and/or X-Ray Time [ Time Frame: During procedure ]
    As recorded by an X-Ray System utilized during the procedure.

  • Patient Radiation Exposure [ Time Frame: During procedure ]
    DAP (dose-area-product) and cumulative dose as recorded during the procedure.

  • Contrast Fluid Volume [ Time Frame: During procedure ]
    No additional description

  • Number of Conversions to Manual [ 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.

  • Measurement of Lesion and Stented Segment Length [ Time Frame: During procedure ]
    1. Visual estimate by clinical operator prior to delivery of PCI device(s).
    2. CorPath 200 System measurement of the segment planned for treatment and length of deployed stent.
    3. Quantitative Coronary Angiography (QCA) of stented segment length


Enrollment: 754
Actual Study Start Date: August 2013
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Study Cohort
Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI)
Procedure: CorPath-assisted Percutaneous Coronary Intervention
Robotic-assisted Percutaneous Coronary Intervention
Other Name: Robotic-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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with coronary artery disease and with the clinical indication for Percutaneous Coronary Intervention (PCI).
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917682

Locations
United States, California
UC San Diego Medical Center
San Diego, California, United States, 92103
United States, Colorado
Valley View Hospital
Glenwood Springs, Colorado, United States, 81601
United States, District of Columbia
Medstar Washington Hospital Center
Washington, D.C., District of Columbia, United States, 20010
United States, Florida
Orlando Regional Medical Center
Orlando, Florida, United States, 32806
United States, Georgia
North Georgia Heart Foundation
Gainesville, Georgia, United States, 30501
United States, Massachusetts
St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
United States, Michigan
Spectrum Health System
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55906
United States, New York
Columbia University Medical Center/New York-Presbyterian Hospital
New York, New York, United States, 10032
St. Joseph's Hospital Health Center
Syracuse, New York, United States, 13203
United States, North Carolina
Carolinas Medical Center - Northeast
Concord, North Carolina, United States, 28203
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, South Dakota
Sanford Health
Sioux Falls, South Dakota, United States, 57104
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Virginia Commonwealth Univ. Medical Center
Richmond, Virginia, United States, 23298
Israel
Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Corindus Inc.
Investigators
Principal Investigator: Giora Weisz, MD Columbia University Medical Center/New York-Presbyterian Hospital
Study Director: Chris Cain VP, Clinical Affairs
  More Information

Additional Information:
Responsible Party: Corindus Inc.
ClinicalTrials.gov Identifier: NCT01917682     History of Changes
Other Study ID Numbers: PRECISION CorPath Registry
Study First Received: August 2, 2013
Last Updated: June 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Corindus Inc.:
robotic-assisted PCI
coronary intervention
CorPath PRECISION Registry
PCI
angioplasty

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 16, 2017