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

Completed

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

Interventions: Procedure: CorPath-assisted Percutaneous Coronary Intervention

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.

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Study Cohort	CorPath-assisted Percutaneous Coronary Intervention	Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Success	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

Name	Time	Method
Number of Participants With In-hospital Major Adverse Coronary Events (MACE)	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.
Number of Participants With an Adverse Event	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.

Locations (16): Valley View Hospital
🇺🇸
Glenwood Springs, Colorado, United States
Medstar Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
North Georgia Heart Foundation
🇺🇸
Gainesville, Georgia, United States
Orlando Regional Medical Center
🇺🇸
Orlando, Florida, United States
Spectrum Health System
🇺🇸
Grand Rapids, Michigan, United States
Carolinas Medical Center - Northeast
🇺🇸
Concord, North Carolina, United States
Sanford Health
🇺🇸
Sioux Falls, South Dakota, United States
Virginia Commonwealth Univ. Medical Center
🇺🇸
Richmond, Virginia, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
Shaare Zedek Medical Center
🇮🇱
Jerusalem, Israel
Columbia University Medical Center/New York-Presbyterian Hospital
🇺🇸
New York, New York, United States
UC San Diego Medical Center
🇺🇸
San Diego, California, United States
St. Elizabeth's Medical Center
🇺🇸
Boston, Massachusetts, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
St. Joseph's Hospital Health Center
🇺🇸
Syracuse, New York, United States
University Hospitals Case Medical Center
🇺🇸
Cleveland, Ohio, United States