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

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

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 2017
Estimated Primary Completion Date:	August 2017 (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)
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:

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.

Exclusion Criteria:

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).
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, RN	(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: Bahman Ghannadian bghannadian@mail.ucsd.edu
Principal Investigator: Ehtisham Mahmud, MD
United States, Colorado
Valley View Hospital	Recruiting
Glenwood Springs, Colorado, United States, 81601
Contact: Kim Williams Kim.Williams@vvh.org
Principal Investigator: Frank A. Laws, MD
United States, Florida
Orlando Regional Medical Center	Recruiting
Orlando, Florida, United States, 32806
Contact: Pamela Peisner 321-841-3706 Pamela.Peisner@orlandohealth.com
Principal Investigator: Vijaykumar Kasi, MD
United States, Georgia
North Georgia Heart Foundation	Recruiting
Gainesville, Georgia, United States, 30501
Contact: Donna Patrick, RN dpatrick@pulseoftomorrow.org
Principal Investigator: Mark Leimbach, MD
United States, Massachusetts
St. Elizabeth's Medical Center	Recruiting
Boston, Massachusetts, United States, 02135
Contact: Lindsay Pothier Lindsay.Pothier@steward.org
Principal Investigator: Joseph P. Carrozza, MD
United States, Michigan
Spectrum Health System	Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Stacie VanOosterhout, MEd 616-486-2031 stacie.vanoosterhout@spectrumhealth.org
Principal Investigator: David Wohns, MD
United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55906
Contact: Mary Thum, MS 507-255-9405 thum.mary@mayo.edu
Principal Investigator: Rajiv Gulati, MD
United States, New York
Columbia University Medical Center/New York-Presbyterian Hospital	Recruiting
New York, New York, United States, 10032
Contact: Andy Morales am2513@cumc.columbia.edu
Principal Investigator: Jeffrey Moses, MD
St. Joseph's Hospital Health Center	Recruiting
Syracuse, New York, United States, 13203
Contact: Tamer Ghobrial tamer.ghobrial@sjhcardiology.org
Principal Investigator: Ronald Caputo, MD
United States, North Carolina
Carolinas Medical Center - Northeast	Recruiting
Concord, North Carolina, United States, 28203
Contact: Janet Patterson janet.patterson@carolinashealthcare.org
Principal Investigator: Paul Campbell, MD
United States, Ohio
University Hospitals Case Medical Center	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 amy.wittrock@sanfordhealth.org
Principal Investigator: Tomasz Stys, MD
United States, Virginia
University of Virginia	Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Laura Hughes, RN, BSN 434-982-1058 LEH9Z@hscmail.mcc.virginia.edu
Principal Investigator: Michael Ragosta, MD
Virginia Commonwealth Univ. Medical Center	Recruiting
Richmond, Virginia, United States, 23298
Contact: Laura Cei lcei@apps.vcu.edu
Principal Investigator: Luis Guzman, MD
Israel
Shaare Zedek Medical Center	Recruiting
Jerusalem, Israel, 91031
Contact: Astrid Rojansky astrid@szmc.org.il
Principal Investigator: Giora Weisz, 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:

Visit the Corindus website for related information. This link exits the ClinicalTrials.gov site


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:	April 15, 2016
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:


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 September 28, 2016

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