Clinical trial NCT01917682: Post-Market CorPath Registry on the CorPath 200 System in Percutaneous Coronary Interventions
Official title: A Post-Market Registry for the Evaluation of the CorPath 200 System Effectiveness in Percutaneous Coronary Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Keywords: robotic-assisted PCI
coronary intervention
CorPath PRECISION Registry
PCI
angioplasty
Lead sponsor: Corindus Inc.
Sponsor class: INDUSTRY
First posted: 2013-08-07
Enrollment: 754
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with coronary artery disease and with the clinical indication for Percutaneous Coronary Intervention (PCI).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Clinical Success
timeFrame: In-hospital (72-hours or discharge, whichever occurs first)
Secondary outcomes:
measure: Number of Participants With In-hospital Major Adverse Coronary Events (MACE)
timeFrame: In-hospital (72-hours or discharge, whichever occurs first)
measure: Number of Participants With an Adverse Event
timeFrame: In-hospital (72-hours or discharge, whichever occurs first)
Other outcomes:
measure: Overall Procedure Time
timeFrame: During procedure
measure: PCI Procedure Time
timeFrame: During procedure
measure: Fluoroscopy and/or X-Ray Time
timeFrame: During procedure
measure: Contrast Fluid Volume
timeFrame: During procedure
measure: Patient Radiation Exposure - Dose-Area-Product
timeFrame: During procedure
measure: Patient Radiation Exposure - Cumulative Dose
timeFrame: During procedure
measure: Number of Participants Who Had a Conversions to Manual Technique.
timeFrame: During procedure
measure: Visual Measurement of Lesion Length
timeFrame: During procedure
measure: CorPath Measurement of Lesion Length
timeFrame: During procedure
Locations:
city: San Diego
country: United States
facility: UC San Diego Medical Center
state: California
city: Glenwood Springs
country: United States
facility: Valley View Hospital
state: Colorado
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Gainesville
country: United States
facility: North Georgia Heart Foundation
state: Georgia
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Columbia University Medical Center/New York-Presbyterian Hospital
state: New York
city: Syracuse
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
city: Concord
country: United States
facility: Carolinas Medical Center - Northeast
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth Univ. Medical Center
state: Virginia
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Columbia University Medical Center/New York-Presbyterian Hospital
name: Giora Weisz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VP, Clinical Affairs
name: Chris Cain
role: STUDY_DIRECTOR
References: