GRX With ReMOTE: First in Human in India

Percutaneous Coronary Intervention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03705481
• Other study ID #: 104-07972
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: December 7, 2018

Study information

• Verified date: January 2020
• Source: Corindus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 7, 2018
• Est. primary completion date: December 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Percutaneous Coronary Intervention

Intervention

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.

Locations

Country	Name	City	State
India	Apex Heart Institute	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Corindus Inc.

Country where clinical trial is conducted

India, 

References & 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 locat — View Citation

Pugin F, Bucher P, Morel P. History of robotic surgery: from AESOP® and ZEUS® to da Vinci®. J Visc Surg. 2011 Oct;148(5 Suppl):e3-8. doi: 10.1016/j.jviscsurg.2011.04.007. Epub 2011 Oct 4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	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).
Secondary	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.

External Links

•   Surgeons perform transatlantic operation using fibreoptics