Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote treatment of PCI. | Other | 5 sequential subjects presenting for remote PCI who have signed informed consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Angiographic Inclusion:
Exclusion Criteria:
Angiographic Exclusion:
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:
Unprotected left main coronary artery disease (an obstruction greater than 50% diameter stenosis in the left main coronary artery)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tejas Patel, MD | Apex Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apex Heart Institute | Ahmedabad | Gujarat | 380054 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28105993 | Result | 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. | |
| 21974854 |
| Label | URL |
|---|---|
| Surgeons perform transatlantic operation using fibreoptics | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Remote Treatment of PCI. | 5 sequential subjects presenting for remote PCI who have signed informed consent. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
5 participants in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Age at Time of Consent | Age at the time of consent for the subjects that had a CorPath robotic PCI procedure performed remotely. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Participants whose age is > 18 years. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Device Technical Success | Defined as completing the robotic PCI entirely with the CorPath GRX POP System. | Number of participants that had a remote robotic assisted PCI without unplanned conversion to manual technique. | Posted | Count of Participants | Participants | Measured from guide catheter in time through procedure end time (or guide catheter out time). |
|
|
MACE that occurs within 48 hours of the procedure or prior to hospital discharge.
Major Adverse Cardiac Event (MACE): MACE is defined as cardiac death, Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target vessel revascularization (TVR) by per-cutaneous or surgical methods.
Serious Adverse Events - all serious adverse events that were collected during the study, whether or not they were anticipated or considered to be attributed or associated with the intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Remote Treatment of PCI. | 5 sequential subjects presenting for remote PCI who have signed informed consent. 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Van Vleet, VP Clinical and Regulatory Affairs | Corindus, Inc. | 260-615-8892 | john.vanvleet@corindus.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2018 | Jan 21, 2020 | Prot_SAP_001.pdf |
Not provided
Prospective, single-arm, single center, non-randomized feasibility study
Not provided
Not provided
Not provided
Not provided
|
|
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. |
| 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. |
| Median |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| 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. | Number of participants with an In-hospital MACE occurrence. | Posted | Count of Participants | Participants | 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. | Number of participants with a residual stenosis less than 30% (visual estimate). | Posted | Count of Participants | Participants | 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. | Number of participants with a Serious Adverse Events (SAEs) from the start of the Re- MOTE CorPath procedure until the end of the study | Posted | Count of Participants | Participants | Measured from Sheath in time to discharge or 48 hours, whichever occurs first. |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
Not provided
Not provided