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

To Evaluate Percutaneous Coronary Intervention Assisted by the Control System of Panvascular Interventional Surgery Efficacy and Safety Clinical Trials

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Percutaneous Coronary Intervention
• Intervention / Treatment: Device: Pan-vascular interventional robotic system; Procedure: Traditional artificial percutaneous coronary intervention

• Study Type: Interventional
• Enrollment (Estimated): 159
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junbo Ge; Phone Number: 13767518896; Email: sunjiabao@abrobo.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Anzhen Hospital，Capital Medical University
      • Contact: Hai Gao, MD; Phone Number: 010-64412431
  • Guandong
    • Guanzhou, Guandong, China, 510080
      • The First Affiliated Hospital,Sun Yat-sen University
      • Contact: Xun Hu, MD; Phone Number: 13631446306
  • Linfen
    • Shanxi, Linfen, China, 041000
      • Linfen Central Hospital
      • Contact: Zhiming Shi; Phone Number: 13753520432; Email: 315973663@qq.com
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Shanghai Zhongshan Hospital
      • Contact: Junbo Ge; Phone Number: 13764518896; Email: sunjiabaojiayou@163.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The affiliated hospital of Hangzhou Normal University
      • Contact: Peng Dong, MD; Phone Number: （0571）88303562

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. General Inclusion criteria:

1. 18 years old ≤ age ≤85 years old;
2. have a clinical indication for PCI (clinical evidence of ischemic heart disease or a positive functional study);
3. 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.

2. Angiographic inclusion criteria:

1. The stenosis degree of visual target lesion ≥50%;
2. 2.5mm≤ Visual target vessel diameter ≤4.0mm;
3. Visual target lesions ≤38mm in length, or successive small lesions that can be completely covered by a single stent;
4. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pan-vascular interventional robotic system group; Pan-vascular interventional robotic system assisted PCI	Device: Pan-vascular interventional robotic system; Pan-vascular interventional robotic system assited PCI for delivery and manipulation of guidewires, catheters, and quick exchange balloon dilatation catheters/stents.
Experimental: Artificial control group; Traditional artificial percutaneous coronary intervention	Procedure: Traditional artificial percutaneous coronary intervention; Doctors perform traditional percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success	Immediate postoperative angiography showed residual stenosis < 30% and TIMI blood flow fraction Level 3.	Immediate postoperative angiography
Clinical Success	No MACE occurred in hospital.	Discharge or 48 hours post intervention, whichever comes first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluoroscopy Time	Total Fluoroscopy Time during procedure will be captured.	Procedure
Procedure Time	Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.	Procedure
PCI time	Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.	Procedure
Contrast agent dosage	The total amount of contrast agent used during the whole procedure.	Procedure
Technical success rate	PCI was assisted by the Pan-vascular Interventional Robotic System.; 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.	Procedure
Radiation Exposure	Patient and Main operator radiation exposure dose recorded by portable radiation	Procedure
the Pan-vascular Interventional Robotic Systemt performance evaluation	The performance of the product was subjectively evaluated by the surgeon.	After the operation

Collaborators and Investigators

• Sponsor: Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2024
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CAPTAIN-C

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No