Clinical trial NCT03705481: GRX With ReMOTE: First in Human in India
Official title: CorPath GRX With ReMOTE Proof of Principle (POP): First in Human in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Coronary Intervention
Lead sponsor: Corindus Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Intervention model description: Prospective, single-arm, single center, non-randomized feasibility study
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Device Technical Success
timeFrame: Measured from guide catheter in time through procedure end time (or guide catheter out time).
measure: In-hospital MACE
timeFrame: Measured from Sheath in time to discharge or 48 hours, whichever occurs first.
Secondary outcomes:
measure: Clinical Procedural Success
timeFrame: Measured from guide catheter in time through procedure end time (or guide catheter out time).
measure: All Serious Adverse Events
timeFrame: Measured from Sheath in time to discharge or 48 hours, whichever occurs first.
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Apex Heart Institute
state: Gujarat
Study officials:
affiliation: Apex Heart Institute
name: Tejas Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.