Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Percutaneous Coronary Intervention

Not Applicable

Not yet recruiting

• Conditions: Percutaneous Coronary Intervention; Coronary Heart Disease; Robotic Surgical Procedures
• Interventions: Device: ALLVAS® robotic-assisted PCI

• Registration Number: NCT05642286
• Lead Sponsor: Shanghai Operation Robot Co., Ltd.

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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-11-30
• Study Start: 2022-12-01
• Study First Submitted QC: 2022-12-07
• Last Update Submitted: 2022-12-07
• Study First Posted: 2022-12-08
• Last Update Posted: 2022-12-08
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

1. Patients who voluntarily participate in and sign the informed consent form, and can cooperate to complete the whole trial process;
2. aged over 18 and under 75;
3. 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

1. Acute myocardial infarction occurred within 7 days;
2. The target vessel has received coronary intervention within 30 days;
3. Restenosis in stent of target vessel;
4. Patients with bifurcation lesions whose target vessel branches need to be protected but cannot protect the collateral branches;
5. Hemodynamic instability (including low blood pressure or use of vasopressors to maintain blood pressure;)
6. Three vessel lesions;
7. The target vessel was diagnosed as coronary chronic occlusive disease (CTO) or left main artery stenosis or severe calcification requiring pretreatment;
8. Perforation, dissection or aneurysm of the proximal vessel of the target vessel;
9. Echocardiography showed that left ventricular ejection fraction (LVEF) was less than 50%;
10. Stroke or transient ischemic attack (TIA) occurred within 30 days;
11. Peptic ulcer or gastrointestinal bleeding within 90 days;
12. Estimated glomerular filtration rate eGFR (ckd epi)<30 ml/min/1.73 m2;
13. Platelet count<50 × 109/L or > 700 × 109/L； White blood cell count < 3 × 109/L;
14. Women who are in pregnancy or lactation or have a pregnancy preparation plan during the trial period;
15. People with allergy history or contraindication to antiplatelet drugs, anticoagulants, anesthetics, contrast agents, stent materials and their coating drugs;
16. Severe infections difficult to control;
17. Those who have mental diseases or mental disorders and cannot be described normally;
18. Emergency operation is required for any reason;
19. Those who have participated in clinical trials of other drugs or medical devices within 3 months before screening;
20. The investigator believes that there are other circumstances that are not suitable for this clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robot assisted surgery group	ALLVAS® robotic-assisted PCI	robotic-assisted PCI

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Clinical Procedural Success	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.
Percentage of Patients With Device Technical Success	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.

Secondary Outcome Measures

Name	Time	Method
The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table	1 day	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	1 day	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.