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

C

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

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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