GRX With ReMOTE: First in Human in India

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2018-12-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Percutaneous Coronary Intervention

Study Design

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Intervention Model

SEQUENTIAL

Prospective, single-arm, single center, non-randomized feasibility study

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Remote treatment of PCI.

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

Group Type OTHER

Remote treatment of PCI.

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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CorPath GRX and Proof of Principle System

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes