Percutaneous Coronary InterventionNCT05642286
Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Percutaneous Coronary Intervention
A study testing ALLVAS® robotic-assisted PCI in people with Percutaneous Coronary Intervention and Coronary Heart Disease, run by Shanghai Operation Robot Co., Ltd..
Trial summary
The goal of this study is to evaluate the safety and effectiveness of endovascular interventional surgery instrument control system （ALLVAS®robot）and supporting consumables for coronary artery interventional surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Percutaneous Coronary Intervention, Coronary Heart Disease, Robotic Surgical Procedures
- What is being tested?
- ALLVAS® robotic-assisted PCI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 31 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who voluntarily participate in and sign the informed consent form, and can cooperate to complete the whole trial process;
- aged over 18 and under 75;
- After coronary CT angiography (CTA) or coronary angiography (DSA), the investigator judged that the patients who needed interventional blood supply reconstruction (target vessel diameter ≥ 2.5mm and lesion stenosis ≥ 70%).
Who cannot join
- Acute myocardial infarction occurred within 7 days;
- The target vessel has received coronary intervention within 30 days;
- Restenosis in stent of target vessel;
- Patients with bifurcation lesions whose target vessel branches need to be protected but cannot protect the collateral branches;
- Hemodynamic instability (including low blood pressure or use of vasopressors to maintain blood pressure;)
- Three vessel lesions;
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- The target vessel was diagnosed as coronary chronic occlusive disease (CTO) or left main artery stenosis or severe calcification requiring pretreatment;
- Perforation, dissection or aneurysm of the proximal vessel of the target vessel;
- Echocardiography showed that left ventricular ejection fraction (LVEF) was less than 50%;
- Stroke or transient ischemic attack (TIA) occurred within 30 days;
- Peptic ulcer or gastrointestinal bleeding within 90 days;
- Estimated glomerular filtration rate eGFR (ckd epi)<30 ml/min/1.73 m2;
- Platelet count<50 × 109/L or > 700 × 109/L； White blood cell count < 3 × 109/L;
- Women who are in pregnancy or lactation or have a pregnancy preparation plan during the trial period;
- People with allergy history or contraindication to antiplatelet drugs, anticoagulants, anesthetics, contrast agents, stent materials and their coating drugs;
- Severe infections difficult to control;
- Those who have mental diseases or mental disorders and cannot be described normally;
- Emergency operation is required for any reason;
- Those who have participated in clinical trials of other drugs or medical devices within 3 months before screening;
- The investigator believes that there are other circumstances that are not suitable for this clinical trial.
About this study
Official title: Prospective, Multi Center, Single Group Target Value Study to Evaluate the Safety and Effectiveness of Endovascular Interventional Device Control System and Supporting Consumables for Coronary Intervention
The goal of this study is to evaluate the safety and effectiveness of endovascular interventional surgery instrument control system （ALLVAS®robot）and supporting consumables for coronary artery interventional surgery.
Participants will will complete coronary intervention surgery with the assistance of robot system（ALLVAS®robot）, and evaluate the effect of the use effect of robots and clinical treatment after surgery
Read the detailed description
Interventional therapy plays an important role in the treatment of coronary heart disease. At present, the main treatment methods still rely on human hands, and there are some defects, including but not limited to hand shaking and visual error. The use of robots may partly circumvent the above shortcomings.
This study is to evaluate the safety and effectiveness of ALLVAS®robot for coronary artery interventional surgery.
- Being tested
- ALLVAS® robotic-assisted PCI
- Keywords
- Robotic Surgical Procedures, PCI, CHD
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLVAS® robotic-assisted PCIDevice
ALLVAS® robotic-assisted PCI
| Study group | Role | What they receive |
|---|---|---|
| Robot assisted surgery group | Experimental | robotic-assisted PCI Receives: Device: ALLVAS® robotic-assisted PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Device Technical Success
Defined as after the operator completed intracoronary therapy of coronary artery with robot assistance, the ratio of successful subjects with instrument technology among all enrolled subjects was reached.
Measured: 1 day
Percentage of Participants With Clinical Procedural Success
Defined as after the operator completed intracoronary coronary artery therapy with robot assistance, the ratio of clinically successful subjects among all enrolled subjects was reached.
Measured: 3 days or hospital discharge, whichever occurs first
Secondary outcomes (2)
The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table
Defined as the difference between the radiation exposure measured at the procedure table (the conventional site of the primary operator) and the radiation exposure measured at the primary operator's position during the procedure.
Measured: 1 day
Evaluation of operational performance of experimental medical devices
Multiple evaluation forms, including those for stability, operation convenience,interface friendliness, image clarity, need to be completed postoperatively by operator. These include one or more levels such as excellent, good, general, poor, etc.
Stability refers to whether the operator has any abnormal situation during the use of the device; Operation convenience refers to whether the operator is smooth in the process of using the instrument.
Interface friendliness and image clarity refer to whether the operator has any doubt or confusion about the interface image feedback during the use of the instrument and the clarity of the interface image during operation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 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
- Model description
- prospective, multi center, single group target value design is adopted; 218 subjects who met the inclusion criteria and did not meet the exclusion criteria were planned to be included in the study, and the trial medical devices were used to assist surgery and complete follow-up, so as to evaluate the safety and effectiveness of the trial medical devices.
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Operation Robot Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642286
- Sponsor's protocol ID
- XMLY3001-01A
- Status last verified
- Oct 2022
- First submitted
- 30 Nov 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi Center, Single Group Target Value Study to Evaluate the Safety and Effectiveness of Endovascular Interventional Device Control System and Supporting Consumables for Coronary Intervention
- ClinicalTrials.gov ID
- NCT05642286
- Acronym / sponsor ID
- XMLY3001-01A
- Keywords
- Robotic Surgical Procedures, PCI, CHD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Shanghai Operation Robot Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Dec 2022 (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 study is to evaluate the safety and effectiveness of endovascular interventional surgery instrument control system （ALLVAS®robot）and supporting consumables for coronary artery interventional surgery.
Participants will will complete coronary intervention surgery with the assistance of robot system（ALLVAS®robot）, and evaluate the effect of the use effect of robots and clinical treatment after surgery
Detailed description
Interventional therapy plays an important role in the treatment of coronary heart disease. At present, the main treatment methods still rely on human hands, and there are some defects, including but not limited to hand shaking and visual error. The use of robots may partly circumvent the above shortcomings.
This study is to evaluate the safety and effectiveness of ALLVAS®robot for coronary artery interventional surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, multi center, single group target value design is adopted; 218 subjects who met the inclusion criteria and did not meet the exclusion criteria were planned to be included in the study, and the trial medical devices were used to assist surgery and complete follow-up, so as to evaluate the safety and effectiveness of the trial medical devices.
| Arm | Type | Receives |
|---|---|---|
| Robot assisted surgery group | Experimental | Device: ALLVAS® robotic-assisted PCIrobotic-assisted PCI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who voluntarily participate in and sign the informed consent form, and can cooperate to complete the whole trial process;
- aged over 18 and under 75;
- After coronary CT angiography (CTA) or coronary angiography (DSA), the investigator judged that the patients who needed interventional blood supply reconstruction (target vessel diameter ≥ 2.5mm and lesion stenosis ≥ 70%).
Key exclusion criteria (20 listed)
- Acute myocardial infarction occurred within 7 days;
- The target vessel has received coronary intervention within 30 days;
- Restenosis in stent of target vessel;
- Patients with bifurcation lesions whose target vessel branches need to be protected but cannot protect the collateral branches;
- Hemodynamic instability (including low blood pressure or use of vasopressors to maintain blood pressure;)
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 |
|---|---|---|
| ALLVAS® robotic-assisted PCIALLVAS® robotic-assisted PCI | Device | Robot assisted surgery group |
Primary outcome
Percentage of Patients With Device Technical Success
Time frame: 1 day
Defined as after the operator completed intracoronary therapy of coronary artery with robot assistance, the ratio of successful subjects with instrument technology among all enrolled subjects was reached.
Percentage of Participants With Clinical Procedural Success
Time frame: 3 days or hospital discharge, whichever occurs first
Defined as after the operator completed intracoronary coronary artery therapy with robot assistance, the ratio of clinically successful subjects among all enrolled subjects was reached.
2 secondary outcomes
The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table
Time frame: 1 day
Evaluation of operational performance of experimental medical devices
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ALLVAS® robotic-assisted PCI in people with Percutaneous Coronary Intervention and Coronary Heart Disease, run by Shanghai Operation Robot Co., Ltd..
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 3 inclusion and 20 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 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Percentage of Patients With Device Technical Success (time frame: 1 day). 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 8 Dec 2022.