The 5th Generation Tele-Robotic-Assisted Percutaneous Coronary Intervention: A First-in-Human Trial

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Cardiovascular Diseases; Coronary Disease
• Interventions: Device: 5G Tele-Robotic-Assisted PCI

• Registration Number: NCT06213714
• Lead Sponsor: Yan'an Affiliated Hospital of Kunming Medical University

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 (PCI).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-09
• Study First Submitted QC: 2024-01-18
• Last Update Submitted: 2024-01-18
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19
• Study Start: 2024-02
• Primary Completion: 2024-06
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
5G Tele-Robotic-Assisted PCI	5G Tele-Robotic-Assisted PCI	VRS100 Robotic Console System, was developed by Shenzhen Raysight Intelligent Medical Technology Co., Ltd., will be used for 5G Tele-Robotic-Assisted Percutaneous Coronary Intervention in this study.

Primary Outcome Measures

Name	Time	Method
Clinical Success	48 hours or hospital discharge, whichever occurs first	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).
Technical Success	1 day	Defined as the successful advancement and retraction of PCI devices using the VRS100 System and without conversion to manual operation.

Secondary Outcome Measures

Name	Time	Method
Contrast Fluid Volume	During procedure	The amount of contrast fluid used (mL) during the procedure.
PCI Procedure Time	During procedure	Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Fluoroscopy and/or X-Ray Time	During procedure	As recorded by an X-Ray System utilized during the procedure.
Overall Procedure Time	During procedure	Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Patient Radiation Exposure - Cumulative Dose	During procedure	Cumulative dose (mGy) as recored during the procedure.