Status:
NOT_YET_RECRUITING
The 5th Generation Tele-Robotic-Assisted Percutaneous Coronary Intervention: A First-in-Human Trial
Lead Sponsor:
Yan'an Affiliated Hospital of Kunming Medical University
Collaborating Sponsors:
Shanghai Zhongshan Hospital
Kunming Chenggong District People's Hospital
Conditions:
Coronary Artery Disease
Myocardial Ischemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to examine the safety and effectiveness, from both clinical and technical perspectives, of utilizing the 5G-Robotic VRS100 system in percutaneous coronary intervention (...
Eligibility Criteria
Inclusion
- General
- Age ≥18 years.
- Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI).
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- Angiographic
- De-novo coronary artery disease.
- Reference vessel diameter is 2.5-4.0mm by visual estimate.
- Target lesion length is ≤30.0mm.
- Target lesion is a single de-novo native coronary artery lesion. This lesion may consist of multiple lesions (with ≤10mm between diseased segments) and must be completely covered by a single stent with ≥5.0mm of normal segments on proximal and distal edges of the lesion.
- Target lesion diameter showing stenosis ≥70% by visual estimate, or ≥50% with myocardial ischemia.
- Target lesion angiography meets the calculation criteria of Rui-Xin AngioQFA, and AngioQFA is ≤0.8.
Exclusion
- Patients meeting any of the following criteria will be excluded:
- General
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06213714
Start Date
February 1 2024
End Date
September 1 2024
Last Update
January 19 2024
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