Clinical trial NCT06502938: A Clinical Trial Evaluating the Pan-vascular Interventional Robotic System for Panvascularization Interventional Surgery
Official title: To Evaluate Percutaneous Coronary Intervention Assisted by the Control System of Panvascular Interventional Surgery Efficacy and Safety Clinical Trials
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Percutaneous Coronary Intervention
Lead sponsor: Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-16
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Success
timeFrame: Immediate postoperative angiography
measure: Clinical Success
timeFrame: Discharge or 48 hours post intervention, whichever comes first
Secondary outcomes:
measure: Technical success rate
timeFrame: Procedure
measure: Radiation Exposure
timeFrame: Procedure
measure: Fluoroscopy Time
timeFrame: Procedure
measure: Contrast agent dosage
timeFrame: Procedure
measure: Procedure Time
timeFrame: Procedure
measure: PCI time
timeFrame: Procedure
measure: the Pan-vascular Interventional Robotic Systemt performance evaluation
timeFrame: After the operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital,Capital Medical University
state: Beijing
city: Guanzhou
country: China
facility: The First Affiliated Hospital,Sun Yat-sen University
state: Guandong
city: Shanxi
country: China
facility: Linfen Central Hospital
state: Linfen
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Hangzhou
country: China
facility: The Affiliated Hospital of Hangzhou Normal University
state: Zhejiang
Study officials:
References: