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

Coronary Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05642286
• Other study ID #: XMLY3001-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Shanghai Operation Robot Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 218
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Percutaneous Coronary Intervention
• Robotic Surgical Procedures

Intervention

Device:
• ALLVAS® robotic-assisted PCI
ALLVAS® robotic-assisted PCI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Operation Robot Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Primary	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.	3 days or hospital discharge, whichever occurs first
Secondary	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.	1 day
Secondary	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.	1 day