GRX With ReMOTE: First in Human in India

NCT03705481 | Completed Results FDA Device

• 1 other identifier: 104-07972
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and performance of CorPath GRX POP System, in the ReMOTE (location outside hospital) delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.

Conditions

Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (2)

• Device Technical Success

  Defined as completing the robotic PCI entirely with the CorPath GRX POP System.

  Measured from guide catheter in time through procedure end time (or guide catheter out time).

• In-hospital MACE

  Recording any MACE event that occurred from the time the sheath was inserted through 48 hours post procedure or hospital discharge, whichever of the two occurred first.

  Measured from Sheath in time to discharge or 48 hours, whichever occurs first.

Secondary Outcomes (2)

• Clinical Procedural Success

  Measured from guide catheter in time through procedure end time (or guide catheter out time).

• All Serious Adverse Events

  Measured from Sheath in time to discharge or 48 hours, whichever occurs first.

Study Arms (1)

Remote treatment of PCI.

OTHER

5 sequential subjects presenting for remote PCI who have signed informed consent.

Device: Remote treatment of PCI.

Interventions

Remote treatment of PCI. DEVICE

To evaluate the safety and performance of CorPath GRX POP System, in the ReMOTE (location outside hospital) delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.

Also known as: CorPath GRX and Proof of Principle System

Remote treatment of PCI.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Patients with coronary artery disease with clinical indication for PCI;
• Patient deemed appropriate for robotic-assisted PCI; and
• The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
• Study lesion is a single de novo native coronary artery lesion (i.e. a coronary lesion not previously treated).
• The lesion reference vessel diameter is between 2.50 mm and 4.0 mm by visual estimate.
• Study lesion length less or equal to 20 mm by visual estimate.
• The study lesion length can be treated with one stent. The stent should be able to cover the whole length of the lesion with at least 2 mm of normal segments on proximal and distal edges of the lesion.
• Study lesion diameter showing significant stenosis of at least 50% by visual estimate.

You may not qualify if:

• Failure/inability/unwillingness to provide informed consent; or
• The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.
• Target lesion that cannot be fully covered by a single stent.
• Subject requires treatment of multiple lesions
• Any previous stent placement within 5 mm (proximal or distal) of the target lesion
• The study lesion requires planned treatment with DCA, laser, rotational atherectomy, or any device except for balloon dilatation prior to stent placement
• The study vessel has evidence of intraluminal thrombus or moderate to severe tortuosity (\> 90°) proximal to the target lesion
• The study lesion has any of the following characteristics:
• Total occlusion
• Within 2mm of a side branch \> 2.0 mm vessel diameter
• Not ostial in location
• Is located at ≥ 45° bend in the vessel
• Is severely tortuous
• Is severely calcified
• Severe calcification at the part of the vessel proximal to target lesion

Sponsors & Collaborators

• Corindus Inc.: lead

Study Sites (1)

Apex Heart Institute

Ahmedabad, Gujarat, 380054, India

Location

Related Publications (2)

• Madder RD, VanOosterhout SM, Jacoby ME, Collins JS, Borgman AS, Mulder AN, Elmore MA, Campbell JL, McNamara RF, Wohns DH. Percutaneous coronary intervention using a combination of robotics and telecommunications by an operator in a separate physical location from the patient: an early exploration into the feasibility of telestenting (the REMOTE-PCI study). EuroIntervention. 2017 Jan 20;12(13):1569-1576. doi: 10.4244/EIJ-D-16-00363.

  PMID: 28105993 RESULT

• Pugin F, Bucher P, Morel P. History of robotic surgery: from AESOP(R) and ZEUS(R) to da Vinci(R). J Visc Surg. 2011 Oct;148(5 Suppl):e3-8. doi: 10.1016/j.jviscsurg.2011.04.007. Epub 2011 Oct 4. No abstract available.

  PMID: 21974854 RESULT

Related Links

• Surgeons perform transatlantic operation using fibreoptics

Results Point of Contact

• Title: John Van Vleet, VP Clinical and Regulatory Affairs
• Organization: Corindus, Inc.

john.vanvleet@corindus.com

260-615-8892

Study Officials

• Tejas Patel, MD

  Apex Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm, single center, non-randomized feasibility study

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 15, 2018
• Study Start: December 3, 2018
• Primary Completion: December 6, 2018
• Study Completion: December 7, 2018
• Last Updated: January 31, 2020
• Results First Posted: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)