Percutaneous Coronary Intervention
Conditions
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.
Interventions
DEVICERemote 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.
Sponsors
Corindus Inc.
Study design
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Prospective, single-arm, single center, non-randomized feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Technical Success | Measured from guide catheter in time through procedure end time (or guide catheter out time). | Defined as completing the robotic PCI entirely with the CorPath GRX POP System. |
| In-hospital MACE | Measured from Sheath in time to discharge or 48 hours, whichever occurs first. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Procedural Success | Measured from guide catheter in time through procedure end time (or guide catheter out time). | 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. |
| All Serious Adverse Events | Measured from Sheath in time to discharge or 48 hours, whichever occurs first. | Recording any SAE that occurred measured from the sheath insertion time through 48 hours post procedure or hospital discharge, whichever occurred first. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Age at Time of Consent Age at the time of consent for the subjects that had a CorPath robotic PCI procedure performed remotely. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Age at Time of Consent | — |
|---|---|---|
| Age, Continuous | 54 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Device Technical Success
Defined as completing the robotic PCI entirely with the CorPath GRX POP System.
Time frame: Measured from guide catheter in time through procedure end time (or guide catheter out time).
Population: Number of participants that had a remote robotic assisted PCI without unplanned conversion to manual technique.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Technical Success | Device Technical Success | 5 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.
Time frame: Measured from Sheath in time to discharge or 48 hours, whichever occurs first.
Population: Number of participants with an In-hospital MACE occurrence.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Technical Success | In-hospital MACE | 0 Participants |
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.
Time frame: Measured from Sheath in time to discharge or 48 hours, whichever occurs first.
Population: Number of participants with a Serious Adverse Events (SAEs) from the start of the Re- MOTE CorPath procedure until the end of the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Technical Success | All Serious Adverse Events | 0 Participants |
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.
Time frame: Measured from guide catheter in time through procedure end time (or guide catheter out time).
Population: Number of participants with a residual stenosis less than 30% (visual estimate).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Technical Success | Clinical Procedural Success | 5 Participants |