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NCT Number: NCT06502938

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital,Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • General Inclusion criteria:
  • 18 years old ≤ age ≤85 years old;
  • have a clinical indication for PCI (clinical evidence of ischemic heart disease or a positive functional study);
  • 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.
  • Angiographic inclusion criteria:
  • The stenosis degree of visual target lesion ≥50%;
  • 2.5mm≤ Visual target vessel diameter ≤4.0mm;
  • Visual target lesions ≤38mm in length, or successive small lesions that can be completely covered by a single stent;
  • Target lesions to be treated intraoperatively cannot be treated in stages.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

Pan-vascular interventional robotic system

Device

Pan-vascular interventional robotic system assited PCI for delivery and manipulation of guidewires, catheters, and quick exchange balloon dilatation catheters/stents.

Traditional artificial percutaneous coronary intervention

Procedure

Doctors perform traditional percutaneous coronary intervention

Primary outcomes

  1. Clinical Success

    Time frame: Immediate postoperative angiography

    Immediate postoperative angiography showed residual stenosis < 30% and TIMI blood flow fraction Level 3.

  2. Clinical Success

    Time frame: Discharge or 48 hours post intervention, whichever comes first

    No MACE occurred in hospital.

Secondary outcomes

  1. Technical success rate

    Time frame: Procedure

    • 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.
  2. Radiation Exposure

    Time frame: Procedure

    Patient and Main operator radiation exposure dose recorded by portable radiation

  3. Fluoroscopy Time

    Time frame: Procedure

    Total Fluoroscopy Time during procedure will be captured.

  4. Contrast agent dosage

    Time frame: Procedure

    The total amount of contrast agent used during the whole procedure.

  5. Procedure Time

    Time frame: Procedure

    Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.

  6. PCI time

    Time frame: Procedure

    Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.

  7. the Pan-vascular Interventional Robotic Systemt performance evaluation

    Time frame: After the operation

    The performance of the product was subjectively evaluated by the surgeon.

Study contacts

Contact information is provided by the study sponsor or research team.

Junbo Ge

CONTACT

[email protected]

13767518896

Sponsors and collaborators

Lead sponsor

Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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