Clinical trial NCT03278301: PRECISION GRX Registry
Official title: A Multicenter Post-Market Registry for the Evaluation of the CorPath® GRX System Effectiveness in Percutaneous Coronary Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Corindus Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-11
Enrollment: 952
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with coronary artery disease and with a clinical indication for PCI.

Brief summary: To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath GRX System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.

Detailed description: This is a single-arm, open-label, multi-center patient registry of the CorPath GRX System to examine its performance during PCI procedures and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.

Eligibility criteria: Inclusion Criteria:

Candidates will be included in the study only if all of the following conditions are met:

1. Age ≥18 years;
2. Patients with coronary artery disease with clinical indication for PCI;
3. Patient deemed appropriate for robotic-assisted PCI; and
4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

* Candidates will be excluded from the study if any of the following conditions are present:

  1. Failure/inability/unwillingness to provide informed consent; or
  2. The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.

Primary outcomes:
measure: Clinical Success
timeFrame: Discharge or 72 hours post intervention, whichever comes first.
measure: Technical Success
timeFrame: Procedure
Secondary outcomes:
measure: Overall Procedure Time
timeFrame: Procedure
measure: PCI Procedure Time
timeFrame: Procedure
measure: Fluoroscopy Time
timeFrame: Procedure
measure: Patient Radiation Exposure
timeFrame: Procedure
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC San Diego Health Sulpizio Cardiovascular Center
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals Fred and Lena Meijer Heart Center
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital - Troy
state: Michigan
city: Kansas City
country: United States
facility: St. Luke's Hospital of Kansas City
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: New York-Presbyterian Columbia University Medical Center
state: New York
city: Raleigh
country: United States
facility: WakeMed Raleigh Campus
state: North Carolina
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: York
country: United States
facility: Wellspan York Hospital
state: Pennsylvania
city: Jackson
country: United States
facility: Jackson-Madison County General Hospital
state: Tennessee
city: Dallas
country: United States
facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital
state: Texas
city: Fort Worth
country: United States
facility: Baylor Scott and White All Saints Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System University Hospital
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: São Paulo
country: Brazil
facility: Albert Einstein Israelite Hospital
state: Sao Paulo
city: Ahmedabad
country: India
facility: Apex Heart Institute
state: Gujarat
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: University of California, San Diego
name: Ehtisham Mahmud, MD
role: PRINCIPAL_INVESTIGATOR
References: