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

Launched by SHENZHEN RAYSIGHT INTELLIGENT MEDICAL TECHNOLOGY CO., LTD. · Sep 4, 2023

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ClinConnect Summary

The ESSENCE trial is looking at a new system called the VRS100, which is designed to help doctors perform a type of heart procedure known as percutaneous coronary intervention (PCI). This procedure is used to treat blockages in the arteries of the heart, which can lead to serious conditions like heart attacks. The main goal of this study is to see how safe and effective the VRS100 system is for guiding tools like stents and balloons during these procedures.

To be eligible for the trial, participants need to be at least 18 years old and have been diagnosed with coronary artery disease. They should also be planning to undergo a PCI. However, certain conditions might exclude someone from participating, such as having recently had a heart attack or stroke, severe heart failure, or other serious health issues. If someone joins the trial, they can expect to receive care using the VRS100 system while being closely monitored by the research team. This trial is not currently recruiting participants, but it aims to improve heart care for patients in the future.

Gender

ALL

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.