Percutaneous Coronary InterventionNCT03705481
GRX With ReMOTE: First in Human in India
A study testing Remote treatment of PCI. in people with Percutaneous Coronary Intervention, run by Siemens Healthineers Endovascular Robotics, Inc. at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- Remote treatment of PCI.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIndia
- Study dates
- 3 Dec 2018to 7 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Patients with coronary artery disease with clinical indication for PCI;
- Patient deemed appropriate for robotic-assisted PCI; and
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- Angiographic Inclusion:
- Study lesion is a single de novo native coronary artery lesion (i.e. a coronary lesion not previously treated).
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- The lesion reference vessel diameter is between 2.50 mm and 4.0 mm by visual estimate.
- Study lesion length less or equal to 20 mm by visual estimate.
- 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.
- Study lesion diameter showing significant stenosis of at least 50% by visual estimate.
Who cannot join
- Failure/inability/unwillingness to provide informed consent; or
- The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.
- 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
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- 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:
- Total occlusion
- Within 2mm of a side branch > 2.0 mm vessel diameter
- Not ostial in location
- Is located at ≥ 45° bend in the vessel
- Is severely tortuous
- Is severely calcified
- Severe calcification at the part of the vessel proximal to target lesion
- 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
- Unprotected left main coronary artery disease (an obstruction greater than 50% diameter stenosis in the left main coronary artery)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CorPath GRX With ReMOTE Proof of Principle (POP): First in Human in India
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.
Read the 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.
- Conditions
- Percutaneous Coronary Intervention
- Being tested
- Remote treatment of PCI.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote treatment of PCI.Device
Also called CorPath GRX and Proof of Principle System
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.
| Study group | Role | What they receive |
|---|---|---|
| Remote treatment of PCI. | Other | 5 sequential subjects presenting for remote PCI who have signed informed consent. Receives: Device: Remote treatment of PCI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Technical Success
Defined as completing the robotic PCI entirely with the CorPath GRX POP System.
Measured: 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: Measured from Sheath in time to discharge or 48 hours, whichever occurs first.
Secondary outcomes (2)
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: Measured from guide catheter in time through procedure end time (or guide catheter out time).
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: Measured from Sheath in time to discharge or 48 hours, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start3 Dec 2018
- Primary completion6 Dec 2018
- Study completion7 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Intervention model
- Sequential
- Model description
- Prospective, single-arm, single center, non-randomized feasibility study
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tejas Patel, MD, Principal investigator, Apex Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705481
- Sponsor's protocol ID
- 104-07972
- Status last verified
- Jan 2020
- First submitted
- 8 Oct 2018
- Last updated
- 31 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28105993Pugin 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.
PubMed 21974854
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorPath GRX With ReMOTE Proof of Principle (POP): First in Human in India
- ClinicalTrials.gov ID
- NCT03705481
- Acronym / sponsor ID
- 104-07972
- Conditions
- Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Siemens Healthineers Endovascular Robotics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 6 Dec 2018 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Posted 31 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-arm, single center, non-randomized feasibility study
| Arm | Type | Receives |
|---|---|---|
| Remote treatment of PCI. | Other | Device: Remote treatment of PCI.5 sequential subjects presenting for remote PCI who have signed informed consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years;
- Patients with coronary artery disease with clinical indication for PCI;
- Patient deemed appropriate for robotic-assisted PCI; and
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- Study lesion is a single de novo native coronary artery lesion (i.e. a coronary lesion not previously treated).
Key exclusion criteria (18 listed)
- Failure/inability/unwillingness to provide informed consent; or
- The investigator determines that the patient or the coronary anatomy is not suitable for robotic-assisted PCI.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote treatment of PCI.Also: CorPath GRX and Proof of Principle SystemTo 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. | Device | Remote treatment of PCI. |
Primary outcome
Device Technical Success
Time frame: 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
Time frame: 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.
2 secondary outcomes
Clinical Procedural Success
Time frame: Measured from guide catheter in time through procedure end time (or guide catheter out time).
All Serious Adverse Events
Time frame: Measured from Sheath in time to discharge or 48 hours, whichever occurs first.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28105993Madder 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.
- Results publication: PubMed 21974854Pugin 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.
- Surgeons perform transatlantic operation using fibreopticsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tejas Patel, MD principal investigator
Apex Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote treatment of PCI. in people with Percutaneous Coronary Intervention, run by Siemens Healthineers Endovascular Robotics, Inc. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Technical Success (time frame: Measured from guide catheter in time through procedure end time (or guide catheter out time).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03705481, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.