Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)

Not Applicable

Not yet recruiting

• Conditions: Arteriosclerosis; Coronary Artery Disease; Cardiovascular Diseases; Myocardial Ischemia; Vascular Disease Occlusive; Coronary Disease
• Interventions: Procedure: VRS100 robotic-assisted PCI; Procedure: Manual PCI

• Registration Number: NCT06032572
• Lead Sponsor: Shenzhen Raysight Intelligent Medical Technology Co., Ltd.

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-04
• Study First Submitted QC: 2023-09-04
• Last Update Submitted: 2023-09-04
• Study Start: 2023-09-08
• Study First Posted: 2023-09-13
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 204

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VRS100 robotic-assisted PCI	VRS100 robotic-assisted PCI	VRS100 robotic-assisted PCI
Manual PCI	Manual PCI	Manual PCI

Primary Outcome Measures

Name	Time	Method
Technical Success	1 day	Defined as the successful advancement and retraction of PCI devices using the VRS100 System and without conversion to manual operation.
Clinical Success	48-hrs 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).

Secondary Outcome Measures

Name	Time	Method
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.
PCI Procedure Time	During procedure	Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Patient Radiation Exposure - Cumulative Dose	During procedure	Cumulative dose (mGy) as recored during the procedure.
Contrast Fluid Volume	During procedure	The amount of contrast fluid used (mL) during the procedure.
Performance of the Experimental Device	During procedure	The frequency of failures and performance evaluation

Trial Locations

Locations (3)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuang, China

Shenzhen People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China