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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Corindus Inc.
Sponsor:
Information provided by (Responsible Party):
Corindus Inc.
ClinicalTrials.gov Identifier:
NCT01917682
First received: August 2, 2013
Last updated: June 10, 2014
Last verified: June 2014
  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
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

Resource links provided by NLM:


Further study details as provided by Corindus Inc.:

Primary Outcome Measures:
  • Clinical Success [ Time Frame: In-hospital (72 hours or discharge, whichever occurs first) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    As recorded by an X-Ray System utilized during the procedure.

  • Patient Radiation Exposure [ Time Frame: During procedure ] [ Designated as safety issue: No ]
    DAP (dose-area-product) and cumulative dose as recorded during the procedure.

  • Contrast Fluid Volume [ Time Frame: During procedure ] [ Designated as safety issue: No ]
    No additional description

  • Number of Conversions to Manual [ Time Frame: During procedure ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 2000
Study Start Date: August 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Chris Cain, VP, Clinical Affairs (508) 653-3335 ext 202 chris.cain@corindus.com

Locations
United States, California
UC San Diego Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Ehtisham Mahmud, MD       emahmud@ucsd.edu   
Principal Investigator: Ehtisham Mahmud, MD         
Sub-Investigator: Mitul Patel, MD         
United States, Colorado
Valley View Hospital Recruiting
Glenwood Springs, Colorado, United States, 81601
Contact: Richelle (Shelley) Reed, RN    970-384-7282    richelle.reed@vvh.org   
Principal Investigator: Frank A. Laws, MD         
Sub-Investigator: Kimberly Johnson, NP         
United States, Florida
Orlando Regional Medical Center Not yet recruiting
Orlando, Florida, United States, 32806
Contact: Vijaykumar Kasi, MD       vijaykasimd@gmail.com   
Principal Investigator: Vijaykumar Kasi, MD         
United States, Georgia
Northeast Georgia Heart Center Recruiting
Gainesville, Georgia, United States, 30501
Contact: Donna Patrick, RN    678-989-5001    dpatrick@ngheartcenter.com   
Principal Investigator: Mark Leimbach, MD         
Sub-Investigator: Pradyumna Tummala, MD         
Sub-Investigator: Jeffrey Marshall, MD         
United States, Massachusetts
St. Elizabeth's Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02135
Principal Investigator: Joseph P. Carrozza, MD         
United States, Michigan
Detroit Medical Center Not yet recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Theodore Schreiber, MD         
Spectrum Health Hospital Group Not yet recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Jennifer Schuitema, MA    616-391-6660    Jennifer.Schuitema@spectrumhealth.org   
Principal Investigator: David Wohns, MD         
United States, New York
St. Joseph's Hospital Center Recruiting
Liverpool, New York, United States, 13088
Contact: Christine Lastinger, RN    315-448-6215    clastinger@sjhcardiology.org   
Principal Investigator: Ron Caputo, MD         
Sub-Investigator: Michael Fischi, MD         
Sub-Investigator: Ayman Iskander, MD         
Sub-Investigator: Alan Simons, MD         
Columbia University Medical Center/New York-Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Andy Morales    212-342-4357    am2513@cumc.columbia.edu   
Principal Investigator: Jeffrey Moses, MD         
Sub-Investigator: Ali Aboufares, MD         
Sub-Investigator: Tamim Nazif, MD         
Sub-Investigator: Manish Parikh, MD         
United States, North Carolina
Carolinas Medical Center Not yet recruiting
Charlotte, North Carolina, United States, 28203
Contact: Paul Campbell, MD       paul.campbell@carolinashealthcare.org   
Principal Investigator: Paul Campbell, MD         
United States, Ohio
University Hospitals Case Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Hiram Bezerra, MD       hiram.bezerra@UHhospitals.org   
Principal Investigator: Hiram Bezerra, MD         
United States, South Dakota
Sanford Health Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Amy Wittrock    605-312-2346    amy.wittrock@sanfordhealth.org   
Principal Investigator: Tomasz Stys, MD         
Sub-Investigator: Adam Stys, MD         
Sub-Investigator: Marian Petrasko, MD         
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:
No publications provided

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 10, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 23, 2014