Clinical trial NCT06032572: Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
Official title: Evaluation of the Safety and Effectiveness of the VRS100 Robotic Console System in Percutaneous Coronary Interventions: A Multicenter, Randomised, Non-inferiority Trial (ESSENCE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Vascular Disease Occlusive
Lead sponsor: Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Zhongshan Hospital
name: West China Hospital
name: Shenzhen People's Hospital
First posted: 2023-09-13
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 coronary guidewires and stent/balloon systems for use in percutaneous coronary interventions (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. In situ primary coronary vascular 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.

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).
  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. The study 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. The study vessel has evidence of intraluminal thrombus.
  5. Chronic total occlusion (CTO).
  6. The study 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. The study 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-hrs 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
measure: Performance of the Experimental Device
timeFrame: During procedure
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuang
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Junbo Ge
role: STUDY_DIRECTOR
affiliation: West China Hospital
name: Yong He
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen People's Hospital
name: Da Yin
role: PRINCIPAL_INVESTIGATOR
References: