Clinical trial NCT06213714: The 5th Generation Tele-Robotic-Assisted Percutaneous Coronary Intervention: A First-in-Human Trial
Official title: The 5th Generation Tele-Robotic-Assisted Percutaneous Coronary Intervention: A First-in-Human Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Coronary Disease
Arteriosclerosis
Lead sponsor: Yan'an Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Kunming Chenggong District People's Hospital
First posted: 2024-01-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Success
timeFrame: 48 hours or hospital discharge, whichever occurs first
measure: Technical Success
timeFrame: 1 day
Secondary outcomes:
measure: PCI Procedure Time
timeFrame: During procedure
measure: Overall Procedure Time
timeFrame: During procedure
measure: Fluoroscopy and/or X-Ray Time
timeFrame: During procedure
measure: Patient Radiation Exposure - Cumulative Dose
timeFrame: During procedure
measure: Contrast Fluid Volume
timeFrame: During procedure
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Junbo Ge
role: STUDY_CHAIR
affiliation: Shanghai Zhongshan Hospital
name: Chenguang Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Yan'an Affiliated Hospital of Kunming Medical University
name: Qiang Xue
role: PRINCIPAL_INVESTIGATOR
affiliation: Kunming Chenggong District People's Hospital
name: Wangxiong Li
role: PRINCIPAL_INVESTIGATOR
References: