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

Corindus

Status: Completed

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

Treatments: Procedure: CorPath-assisted Percutaneous Coronary Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01917682

PRECISION CorPath Registry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 754 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

754 participants in 1 patient group

Study Cohort

Description:

Subjects treated with CorPath-assisted Percutaneous Coronary Intervention (PCI)

Treatment:

Procedure: CorPath-assisted Percutaneous Coronary Intervention