Status:
UNKNOWN
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
Lead Sponsor:
Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
Collaborating Sponsors:
Shanghai Zhongshan Hospital
West China Hospital
Conditions:
Coronary Artery Disease
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the safety and effectiveness of the clinical and technical performance of the VRS100 system with disposable surgical kit in the delivery and manipulation of ...
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
- In situ primary coronary vascular 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.
Exclusion
- Patients meeting any of the following criteria will be excluded:
- General
Key Trial Info
Start Date :
September 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT06032572
Start Date
September 8 2023
End Date
August 1 2024
Last Update
September 13 2023
Active Locations (3)
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1
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
2
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
3
West China Hospital of Sichuan University
Chengdu, Sichuang, China, 610041