A Clinical Trial Evaluating the Pan-vascular Interventional Robotic System for Panvascularization Interventional Surgery

Not Applicable

Not yet recruiting

• Conditions: Percutaneous Coronary Intervention
• Interventions: Device: Pan-vascular interventional robotic system; Procedure: Traditional artificial percutaneous coronary intervention

• Registration Number: NCT06502938
• Lead Sponsor: Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.

Brief Summary

The purpose of this prospective, randomized, open, parallel controlled, multicenter trial is to investigate the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI). Investigators will evaluate clinical success, technical success, and record intraoperative data (PCI time, total operating time, contrast agent dose, radiation exposure dose, etc.). All subjects were followed up on the day of surgery, before discharge and 1 month after surgery to observe the safety indicators.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Study Start: 2024-07-15
• Study First Posted: 2024-07-16
• Last Update Posted: 2024-07-16
• Primary Completion: 2025-07-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

1. General Inclusion criteria:

2. 18 years old ≤ age ≤85 years old;

3. have a clinical indication for PCI (clinical evidence of ischemic heart disease or a positive functional study);

4. Subject or guardian can understand the purpose of the experiment and sign informed consent voluntarily Book and willing to cooperate to complete the follow-up.

5. Angiographic inclusion criteria:

6. The stenosis degree of visual target lesion ≥50%;

7. 2.5mm≤ Visual target vessel diameter ≤4.0mm;

8. Visual target lesions ≤38mm in length, or successive small lesions that can be completely covered by a single stent;

9. Target lesions to be treated intraoperatively cannot be treated in stages.

Exclusion Criteria

1. General exclusion criteria 1)A stroke occurred within 30 days prior to surgery; 2)Percutaneous coronary intervention was performed within 72 hours before surgery; 3)Acute myocardial infarction, cardiogenic shock, or infarction occurred within 48 hours before surgery Received CPR; 4)Other cardiac procedures (such as aortic valve placement) are scheduled within 30 days of surgery Coronary artery bypass grafting, etc.); 5)Pregnant or lactating female subjects; 6)Severe hepatic or renal insufficiency or bleeding tendency; 7)Known allergy to interventional device materials and their coatings, or allergy to contrast agents; 8)Severe stenosis, occlusion of blood vessels at the intended puncture site, or local skin infection and uncontrollable; 9)Are participating in other interventional clinical studies, and have not completed the evaluation of the primary endpoint of the relevant study; 10)Participants who had other contraindications for interventional therapy or were judged by the investigator to be unsuitable for participation in the study;
2. Angiographic exclusion criteria 1)The TIMI blood flow grade of the target lesion was < 2; 2)Treatment requiring intrastent restenosis, or prior placement of a stent in the target vessel near both ends of the target lesion; 3)Severe tortuosity or severe calcification of blood vessels; 4)There's an intracavitary thrombus; 5)In addition to balloon forming and stent implantation, other treatments (such as atheromatectomy, rotary grinding, laser ablation, etc.) are also required at the same time; 6)The researchers determined that percutaneous coronary intervention was not suitable for robotic assistance or that there might be high risks in the process.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pan-vascular interventional robotic system group	Pan-vascular interventional robotic system	Pan-vascular interventional robotic system assisted PCI
Artificial control group	Traditional artificial percutaneous coronary intervention	Traditional artificial percutaneous coronary intervention

Primary Outcome Measures

Name	Time	Method
Clinical Success	Discharge or 48 hours post intervention, whichever comes first	No MACE occurred in hospital.

Secondary Outcome Measures

Name	Time	Method
Fluoroscopy Time	Procedure	Total Fluoroscopy Time during procedure will be captured.
Contrast agent dosage	Procedure	The total amount of contrast agent used during the whole procedure.
Procedure Time	Procedure	Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Technical success rate	Procedure	1. PCI was assisted by the Pan-vascular Interventional Robotic System.; 2. No unplanned complete conversion to artificial surgery occurred due to the inability to complete the delivery of the guide wire or balloon/stent catheter through the vessel with the test instrument as intended, or due to insufficient guide catheter support.
PCI time	Procedure	Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
the Pan-vascular Interventional Robotic Systemt performance evaluation	After the operation	The performance of the product was subjectively evaluated by the surgeon.
Radiation Exposure	Procedure	Patient and Main operator radiation exposure dose recorded by portable radiation

Trial Locations

Locations (5)

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

The First Affiliated Hospital,Sun Yat-sen University; 🇨🇳 Guanzhou, Guandong, China

Linfen Central Hospital; 🇨🇳 Shanxi, Linfen, China

Beijing Anzhen Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China

The Affiliated Hospital of Hangzhou Normal University; 🇨🇳 Hangzhou, Zhejiang, China