Percutaneous Coronary InterventionNCT06110988
A Clinical Study for the Pan-vascular Interventional Robotic System
A study testing Pan-vascular interventional robotic system in people with Percutaneous Coronary Intervention and Pan-vascular Interventional Robotic System, run by Shenzhen Institute of Advanced Biomedical Robot Co., Ltd. at 2 sites in China.
Trial summary
The goal of this prospective, single-center, single-arm study is to explore the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI), researchers will assess the clinical success, technical success, and record the intraoperative data (PCI time, guidewire… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Percutaneous Coronary Intervention, Pan-vascular Interventional Robotic System
- What is being tested?
- Pan-vascular interventional robotic system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesChina
- Study dates
- 30 Apr 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. General Inclusion criteria:
- 18 years old ≤ age ≤80 years old;
- have a clinical indication for PCI (clinical evidence of ischemic heart disease or a positive functional study);
- Subjects or their legal representative has been informed of the nature of the study, signed informed consent and were willing to cooperate in the follow-up.
- 2. Angiographic inclusion criteria:
- study lesion is a single de novo native coronary artery lesion (previously untreated coronary artery disease);
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- target vessel diameter between 2.5 mm and 4.0 mm;
- single lesion length ≤38 mm, with at least 2.0 mm normal segments on the proximal and distal edges of the lesion;
- stenosis ≥50% and < 100%.
Who cannot join
- 1. General exclusion criteria:
- hemodynamic instability (including hypotension or use of vasopressors to maintain blood pressure);
- STEMI, cardiopulmonary resuscitation, or cardiogenic shock within 7 days before surgery;
- subjects were required to undergo planned PCI or CABG within 30 days after surgery, or had undergone PCI within 72 hours before surgery, or had undergone PCI within 30 days before surgery with a protocol-defined major adverse coronary event (MACE) or serious adverse event (SAE);
- subjects had a stroke or transient ischemic attack (TIA) within 30 days before surgery;
- subjects with active peptic ulcer or upper GI bleeding within 6 months before surgery;
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- The study lesion requires planned treatment with directional coronary atherectomy (DCA), laser, rotational atherectomy or any device except for balloon dilatation prior to stent placement
- left ventricular ejection fraction (LVEF) < 35%;
- subjects with known allergies to or contraindications to antiplatelet drugs, anticoagulants, stent materials and their coatings, or allergies to contrast agents, unable to receive adequate preoperative medication or manage with clinically appropriate alternatives;
- subjects had a history of bleeding tendency or coagulopathy or refused blood transfusion;
- severe liver and kidney dysfunction;
- patients who are scheduled to undergo additional cardiac surgery (e.g., valve replacement or cardiac ablation) within 30 days after surgery;
- inaccessible vascular access (radial artery/femoral artery) or severe vascular stenosis, occlusion or skin infection at the puncture site;
- uncontrolled severe infection;
- subjects participating in clinical studies of other devices or drugs during the same period;
- pregnant and lactating women of childbearing age;
- subjects judged by the investigator to be ineligible for the study.
- 2. Exclusion criteria for angiography:
- in-stent restenosis or any previous stent placement within 5.0 mm (proximal or distal) of the target lesion；
- bifurcation lesions, in which the target vessel branch needs to be protected but cannot be protected;
- the target lesion is located at the ostium or anastomosis of coronary artery;
- investigate evidence of intravascular thrombosis;
- severe tortuosity or calcification of the proximal end of the study vessel or target lesion;
- study the complete occlusion of the lesion;
- Target lesion located in left main coronary artery, or unprotected left main coronary artery disease (> 50% stenosis in left main coronary artery).
Trial locations and contacts
2 sites in 1 country.
China2 sites
Kashi Prefecture Second People's Hospital
Kashgar, Xinjiang
Qingxing Chen, MD, 021-64041990, kseyyxc@163.com
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200000
Junbo Ge, 13764518896, sunjiabaojiayou@163.com
About this study
Official title: A Clinical Study for Pan-vascular Interventional Control System in Percutaneous Coronary Intervention
The goal of this prospective, single-center, single-arm study is to explore the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI), researchers will assess the clinical success, technical success, and record the intraoperative data (PCI time, guidewire operation time, dose of contrast medium, radiation exposure doses, etc). All subjects will be followed up on the day of surgery, before discharge (or 48 hours after surgery) and 1 month after surgery to observe the safety indicators.
- Being tested
- Pan-vascular interventional robotic system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pan-vascular interventional robotic systemDevice
Pan-vascular interventional robotic system assited PCI for delivery and manipulation of guidewires, catheters, and quick exchange balloon dilatation catheters/stents.
| Study group | Role | What they receive |
|---|---|---|
| Pan-vascular interventional robotic system | Experimental | Pan-vascular interventional robotic system assisted PCI Receives: Device: Pan-vascular interventional robotic system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the Pan-vascular interventional robotic system, without in-hospital major adverse coronary events (MACE).
Measured: Discharge or 48 hours post intervention, whichever comes first
Technical Success
Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.
Measured: Procedure
Secondary outcomes (5)
Procedure Time
Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Measured: Procedure
PCI time
Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Measured: Procedure
Fluoroscopy Time
Total Fluoroscopy Time during procedure will be captured
Measured: Procedure
Radiation Exposure
Patient and Main operator radiation exposure dose recorded by portable radiation monitor during the procedure, respectively.
Measured: Procedure
Contrast agent dosage
The total amount of contrast agent used during the whole procedure.
Measured: Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start30 Apr 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Ge Junbo, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110988
- Sponsor's protocol ID
- P02-IIT-KSI
- Status last verified
- Apr 2024
- First submitted
- 25 Oct 2023
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study for Pan-vascular Interventional Control System in Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06110988
- Acronym / sponsor ID
- P02-IIT-KSI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective, single-center, single-arm study is to explore the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI), researchers will assess the clinical success, technical success, and record the intraoperative data (PCI time, guidewire operation time, dose of contrast medium, radiation exposure doses, etc). All subjects will be followed up on the day of surgery, before discharge (or 48 hours after surgery) and 1 month after surgery to observe the safety indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pan-vascular interventional robotic system | Experimental | Device: Pan-vascular interventional robotic systemPan-vascular interventional robotic system assisted PCI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years old ≤ age ≤80 years old;
- have a clinical indication for PCI (clinical evidence of ischemic heart disease or a positive functional study);
- Subjects or their legal representative has been informed of the nature of the study, signed informed consent and were willing to cooperate in the follow-up.
- study lesion is a single de novo native coronary artery lesion (previously untreated coronary artery disease);
- target vessel diameter between 2.5 mm and 4.0 mm;
Key exclusion criteria (25 listed)
- hemodynamic instability (including hypotension or use of vasopressors to maintain blood pressure);
- STEMI, cardiopulmonary resuscitation, or cardiogenic shock within 7 days before surgery;
- subjects were required to undergo planned PCI or CABG within 30 days after surgery, or had undergone PCI within 72 hours before surgery, or had undergone PCI within 30 days before surgery with a protocol-defined major adverse coronary event (MACE) or serious adverse event (SAE);
- subjects had a stroke or transient ischemic attack (TIA) within 30 days before surgery;
- subjects with active peptic ulcer or upper GI bleeding within 6 months before surgery;
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 |
|---|---|---|
| Pan-vascular interventional robotic systemPan-vascular interventional robotic system assited PCI for delivery and manipulation of guidewires, catheters, and quick exchange balloon dilatation catheters/stents. | Device | Pan-vascular interventional robotic system |
Primary outcome
Clinical Success
Time frame: Discharge or 48 hours post intervention, whichever comes first
Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the Pan-vascular interventional robotic system, without in-hospital major adverse coronary events (MACE).
Technical Success
Time frame: Procedure
Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.
5 secondary outcomes
Procedure Time
Time frame: Procedure
PCI time
Time frame: Procedure
Fluoroscopy Time
Time frame: Procedure
Radiation Exposure
Time frame: Procedure
Contrast agent dosage
Time frame: Procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pan-vascular interventional robotic system in people with Percutaneous Coronary Intervention and Pan-vascular Interventional Robotic System, run by Shenzhen Institute of Advanced Biomedical Robot Co., Ltd. at 2 sites in China.
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 9 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qingxing Chen, MD (18999090210, sunjiabao@abrobo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success (time frame: Discharge or 48 hours post intervention, whichever comes first). 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?
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 26 Apr 2024; AzTrials last refreshed its copy on 30 Oct 2026.