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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06213714
Other study ID # 5G Tele-Robotic-Assisted PCI
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date September 2024

Study information

Verified date January 2024
Source Yan'an Affiliated Hospital of Kunming Medical University
Contact Qiang Xue
Phone 13987199913
Email Xueqiang3513@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 (PCI).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date September 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - General Inclusion Criteria: 1. Age =18 years. 2. Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI). 3. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. - Angiographic Inclusion Criteria: 1. De-novo coronary artery disease. 2. Reference vessel diameter is 2.5-4.0mm by visual estimate. 3. Target lesion length is =30.0mm. 4. 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. 5. Target lesion diameter showing stenosis =70% by visual estimate, or =50% with myocardial ischemia. 6. Target lesion angiography meets the calculation criteria of Rui-Xin AngioQFA, and AngioQFA is =0.8. Exclusion Criteria: - Patients meeting any of the following criteria will be excluded: - General Exclusion Criteria: 1. Subjects with indications for urgent PCI surgery. 2. Evidence of an acute myocardial infarction within one week prior to the intended VRS100 procedure. 3. Subject has undergone PCI within 72 hours prior to the VRS100 procedure. 4. Subject has undergone PCI within 30 days prior to the VRS100 procedure and experienced a MACE or a serious adverse event (SAE). 5. Severe heart failure (NYHA IV & LVEF=35%). 6. Subject has suffered a stroke, or has an active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to planned VRS100 procedure. 7. Subject has known hypersensitivity or contraindication to aspirin, heparin, ticagrelor, clopidogrel, bivalirudin, PTX(paclitaxel), stainless steel, etc. 8. Subject has acute or chronic kidney disease (serum creatinine level of >2.5 mg/dL or >221 umol/L) or need dialysis. 9. Pregnant or breastfeeding, or planning to be pregnant. 10. Repeated enrollment. 11. Any other factors that the researchers consider not suitable for inclusion or completion of this study. - Angiographic Exclusion Criteria: 1. Any previous stent placement within 5.0 mm (proximal or distal) of the target lesion. 2. Target lesion requires planned treatment with directional coronary atherectomy (DCA), laser, rotational atherectomy or any device except for balloon dilatation prior to stent placement. 3. Cardiac allograft vasculopathy (CAV). 4. Target lesion/vessel has evidence of intraluminal thrombus. 5. Chronic total occlusion (CTO). 6. Target lesion located in a native vessel distal to an ostial, bifurcation or anastomosis. 7. Unprotected left main coronary artery disease defined as an obstruction greater than 50% diameter stenosis in the left main coronary artery. 8. Target lesion or vessel proximal to the target lesion has severe tortuosity or calcification. 9. Target lesion that cannot be fully covered by a single stent. 10. More than 2 lesions requires treatment in one vessel. 11. Subject requires treatment of more than one vessel.

Study Design


Intervention

Device:
5G Tele-Robotic-Assisted PCI
The 5G Tele-Robotic-Assisted VRS100 system is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Yan'an Affiliated Hospital of Kunming Medical University Kunming Chenggong District People's Hospital, Shanghai Zhongshan Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Success Defined as angiographic success (residual stenosis after stenting of <30% with final TIMI [Thrombolysis In Myocardial Infarction] flow grade 3) without an in-hospital major adverse cardiovascular event (MACE) (cardiovascular death, MI, clinically driven target vessel revascularization). 48 hours or hospital discharge, whichever occurs first
Primary Technical Success Defined as the successful advancement and retraction of PCI devices using the VRS100 System and without conversion to manual operation. 1 day
Secondary PCI Procedure Time Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter. During procedure
Secondary Overall Procedure Time Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter. During procedure
Secondary Fluoroscopy and/or X-Ray Time As recorded by an X-Ray System utilized during the procedure. During procedure
Secondary Patient Radiation Exposure - Cumulative Dose Cumulative dose (mGy) as recored during the procedure. During procedure
Secondary Contrast Fluid Volume The amount of contrast fluid used (mL) during the procedure. During procedure
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