Status:
NOT_YET_RECRUITING
A Clinical Trial Evaluating the Pan-vascular Interventional Robotic System for Panvascularization Interventional Surgery
Lead Sponsor:
Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.
Conditions:
Percutaneous Coronary Intervention
Eligibility:
All Genders
18-85 years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 1\. 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.
- 2\. 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
- 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.
Key Trial Info
Start Date :
July 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2025
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT06502938
Start Date
July 15 2024
End Date
December 15 2025
Last Update
July 16 2024
Active Locations (5)
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1
Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100000
2
The First Affiliated Hospital,Sun Yat-sen University
Guanzhou, Guandong, China, 510080
3
Linfen Central Hospital
Shanxi, Linfen, China, 041000
4
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200000