NAVIGATE GRX Study

NCT04883008 | Terminated FDA Device

• 1 other identifier: 104-09466
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the present study is to detail the results of robotic-assisted PCI using technIQ automated movements in real-world clinical practice.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Major Clinical and Angiographic Complications (MCAC)

  The rate of the combined MCAC endpoint (a composite of MACE and Major Clinical and Angiographic Complications) in the technIQ ON group is not significantly higher than in the technIQ OFF group.

  72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.

• Technical Success

  Residual stenosis of \<30% in all target lesions with final TIMI (Thrombolysis In Myocardial Infarction) flow grade 3 by angiographic core lab analysis, AND absence of unplanned manual conversion.

  During the Procedure

Secondary Outcomes (17)

• PCI procedure time

  During the Procedure

• Procedure success

  72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.

• Major adverse cardiovascular events (MACE),

  72 hours post-procedure or until immediately prior to discharge from the index procedure hospitalization, whichever occurs first.

• Major angiographic complications

  During the Procedure

• Serious Adverse Events (SAE)

  Procedure through 72 hours postprocedure or hospital discharge (whichever occurs)

Study Arms (2)

Intervention

CorPath GRX with technIQ automated movements enabled (technIQ ON)

Device: CorPath GRX with technIQ automated movements enabled (technIQ ON)

Control

CorPath GRX with technIQ automated movements disabled (technIQ OFF).

Device: CorPath GRX with technIQ automated movements disabled (technIQ OFF).

Interventions

CorPath GRX with technIQ automated movements enabled (technIQ ON) DEVICE

The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures. TechnIQ automated movements are software-based automation of common maneuvers that interventionalists perform when manipulating catheters, guidewires, and devices by hand. In this group, automated movements will be enabled and used at the discretion of the interventionalist.

Intervention

CorPath GRX with technIQ automated movements disabled (technIQ OFF). DEVICE

The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures. TechnIQ automated movements are software-based automation of common maneuvers that interventionalists perform when manipulating catheters, guidewires, and devices by hand. In this group, automated movements will be disabled.

Control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The targeted population is subjects with coronary artery disease and with a clinical indication for PCI.

You may qualify if:

• Male or nonpregnant female aged ≥ 20 years.
• Patients with coronary artery disease with clinical indication for Percutaneous Coronary Intervention (PCI).
• The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

You may not qualify if:

• Failure/inability/unwillingness to provide informed consent.
• In the opinion of the investigator, the subject is deemed unsuitable for robotic PCI due to clinical status or anatomic characteristics.
• Acute STEMI within 72 hours pre-procedure.

Sponsors & Collaborators

• Corindus Inc.: lead

Study Sites (1)

Intercard Sp. Z o.o.

Nowy Sącz, Poland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean Fajadet, MD

  Groupe Cardiovasculaire Interventionnel, Clinique Pasteur

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: May 12, 2021
• Study Start: June 14, 2021
• Primary Completion: February 4, 2022
• Study Completion: February 7, 2022
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)