Back to resultsClinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Percutaneous Coronary Intervention
Primary Purpose
Percutaneous Coronary Intervention, Coronary Heart Disease, Robotic Surgical Procedures
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ALLVAS® robotic-assisted PCI
Sponsored by
About this trial
This is an interventional treatment trial for Percutaneous Coronary Intervention focused on measuring Robotic Surgical Procedures, PCI, CHD
Eligibility Criteria
Inclusion Criteria: 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%). Exclusion Criteria: 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; 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robot assisted surgery group
Arm Description
robotic-assisted PCI
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05642286
First Posted
November 30, 2022
Last Updated
December 7, 2022
Sponsor
Shanghai Operation Robot Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05642286
Brief Title
Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Percutaneous Coronary Intervention
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Operation Robot Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Percutaneous Coronary Intervention, Coronary Heart Disease, Robotic Surgical Procedures
Keywords
Robotic Surgical Procedures, PCI, CHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
218 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot assisted surgery group
Arm Type
Experimental
Arm Description
robotic-assisted PCI
Intervention Type
Device
Intervention Name(s)
ALLVAS® robotic-assisted PCI
Intervention Description
ALLVAS® robotic-assisted PCI
Primary Outcome Measure Information:
Title
Percentage of Patients With Device Technical Success
Description
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.
Time Frame
1 day
Title
Percentage of Participants With Clinical Procedural Success
Description
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.
Time Frame
3 days or hospital discharge, whichever occurs first
Secondary Outcome Measure Information:
Title
The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table
Description
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.
Time Frame
1 day
Title
Evaluation of operational performance of experimental medical devices
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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%).
Exclusion Criteria:
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;
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.
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Percutaneous Coronary Intervention
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