GRX With ReMOTE: First in Human in India

CorPath GRX With ReMOTE Proof of Principle (POP): First in Human in India

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.

Study Overview

• Status: Completed
• Conditions: Percutaneous Coronary Intervention
• Intervention / Treatment: Device: Remote treatment of PCI.

Detailed Description

Prospective, single-arm, single center, non-randomized feasibility study of the CorPath GRX POP System to examine its performance during remote angioplasty (ballooning) and stenting and patient outcomes through 48 hours post-PCI procedure hospital discharge, whichever occurs first.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380054
      • Apex Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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.

Angiographic Inclusion:

1. Study lesion is a single de novo native coronary artery lesion (i.e. a coronary lesion not previously treated).
2. The lesion reference vessel diameter is between 2.50 mm and 4.0 mm by visual estimate.
3. Study lesion length less or equal to 20 mm by visual estimate.
4. 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.
5. Study lesion diameter showing significant stenosis of at least 50% by visual estimate.

Exclusion Criteria:

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.

Angiographic Exclusion:

1. Target lesion that cannot be fully covered by a single stent.
2. Subject requires treatment of multiple lesions
3. Any previous stent placement within 5 mm (proximal or distal) of the target lesion
4. The study lesion requires planned treatment with DCA, laser, rotational atherectomy, or any device except for balloon dilatation prior to stent placement
5. The study vessel has evidence of intraluminal thrombus or moderate to severe tortuosity (> 90°) proximal to the target lesion

6. The study lesion has any of the following characteristics:

   1. Total occlusion
   2. Within 2mm of a side branch > 2.0 mm vessel diameter
   3. Not ostial in location
   4. Is located at ≥ 45° bend in the vessel
   5. Is severely tortuous
   6. Is severely calcified
   7. Severe calcification at the part of the vessel proximal to target lesion
   8. Target lesion that is located in a native vessel distal to an anastomosis with a saphenous vein graft or a left/right internal mammary artery (LIMA/RIMA) bypass and is approached through the by-pass graft
7. Unprotected left main coronary artery disease (an obstruction greater than 50% diameter stenosis in the left main coronary artery)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Remote treatment of PCI.; 5 sequential subjects presenting for remote PCI who have signed informed consent.	Device: Remote treatment of PCI.; 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.; Other Names: CorPath GRX and Proof of Principle System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Procedural Success	Number of patients with a residual stenosis (visual estimate, less than 30%) post PCI in the lesion(s) treated with the CorPath GRX POP System.	Measured from guide catheter in time through procedure end time (or guide catheter out time).
All Serious Adverse Events	Recording any SAE that occurred measured from the sheath insertion time through 48 hours post procedure or hospital discharge, whichever occurred first.	Measured from Sheath in time to discharge or 48 hours, whichever occurs first.

Collaborators and Investigators

• Sponsor: Corindus Inc.
• Investigators: Principal Investigator: Tejas Patel, MD, Apex Heart Institute

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Surgeons perform transatlantic operation using fibreoptics

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): December 6, 2018
• Study Completion (Actual): December 7, 2018

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 104-07972

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes