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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-08

Study Completion Date

2024-08-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Coronary Artery Disease Cardiovascular Diseases Coronary Disease Myocardial Ischemia Arteriosclerosis Vascular Disease Occlusive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VRS100 robotic-assisted PCI

Group Type EXPERIMENTAL

VRS100 robotic-assisted PCI

Intervention Type PROCEDURE

The VRS100 is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.

Manual PCI

Group Type ACTIVE_COMPARATOR

Manual PCI

Intervention Type PROCEDURE

Use the traditional technique of manually advancing intracoronary guidewires, balloons, and stents at the patient's tableside.

Interventions

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VRS100 robotic-assisted PCI

The VRS100 is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.

Intervention Type PROCEDURE

Manual PCI

Use the traditional technique of manually advancing intracoronary guidewires, balloons, and stents at the patient's tableside.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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:

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No