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

Coronary Artery Disease Clinical Trial

— PRECISION  

Official title:

A Post-Market Registry for the Evaluation of the CorPath 200 System Effectiveness in Percutaneous Coronary Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917682
• Other study ID #: PRECISION CorPath Registry
• Status: Completed
• Start date: August 2013
• Est. completion date: December 2016

Study information

• Verified date: December 2020
• Source: Corindus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 754
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• CorPath-assisted Percutaneous Coronary Intervention
Robotic-assisted Percutaneous Coronary Intervention

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem
United States	St. Elizabeth's Medical Center	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Carolinas Medical Center - Northeast	Concord	North Carolina
United States	North Georgia Heart Foundation	Gainesville	Georgia
United States	Valley View Hospital	Glenwood Springs	Colorado
United States	Spectrum Health System	Grand Rapids	Michigan
United States	Columbia University Medical Center/New York-Presbyterian Hospital	New York	New York
United States	Orlando Regional Medical Center	Orlando	Florida
United States	Virginia Commonwealth Univ. Medical Center	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	UC San Diego Medical Center	San Diego	California
United States	Sanford Health	Sioux Falls	South Dakota
United States	St. Joseph's Hospital Health Center	Syracuse	New York
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Corindus Inc.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Procedure Time	Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.	During procedure
Other	PCI Procedure Time	Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.	During procedure
Other	Fluoroscopy and/or X-Ray Time	As recorded by an X-Ray System utilized during the procedure.	During procedure
Other	Contrast Fluid Volume	The amount of contrast fluid used (mL) during the procedure.	During procedure
Other	Patient Radiation Exposure - Dose-Area-Product	DAP (dose-area-product) as recorded during the procedure.	During procedure
Other	Patient Radiation Exposure - Cumulative Dose	Cumulative dose (mGy) as recored during the procedure.	During procedure
Other	Number of Participants Who Had a Conversions to Manual Technique.	The overall number of conversions from the robotic PCI to manual PCI will be captured to analyze the technical success of the device.	During procedure
Other	Visual Measurement of Lesion Length	Visual estimate by clinical operator prior to delivery of PCI device(s).	During procedure
Other	CorPath Measurement of Lesion Length	Robotic measurement of lesion length using the CorPath System performed by the Clinical Operator.	During procedure
Primary	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	Number of Participants With In-hospital Major Adverse Coronary Events (MACE)	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.	In-hospital (72-hours or discharge, whichever occurs first)
Secondary	Number of Participants With an Adverse Event	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.	In-hospital (72-hours or discharge, whichever occurs first)

External Links

•   Visit the Corindus website for related information.