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

NCT05642286 | Unknown

• 1 other identifier: XMLY3001-01A
• Study Type: interventional
• Target: 218
• Locations: 0 countries
• Sites: N/A

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

Conditions

Percutaneous Coronary Intervention; Coronary Heart Disease; Robotic Surgical Procedures

Keywords

Robotic Surgical Procedures; PCI; CHD

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• The Ratio Between the Radiation Exposure of the Primary Operator and the Radiation Exposure at the Table

  1 day

• Evaluation of operational performance of experimental medical devices

  1 day

Study Arms (1)

Robot assisted surgery group

EXPERIMENTAL

robotic-assisted PCI

Device: ALLVAS® robotic-assisted PCI

Interventions

ALLVAS® robotic-assisted PCI DEVICE

ALLVAS® robotic-assisted PCI

Robot assisted surgery group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Operation Robot Co., Ltd.: lead

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: December 1, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: December 8, 2022

Record last verified: 2022-10