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

• Sponsor: Shenzhen Raysight Intelligent Medical Technology Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06032572
• Collaborator: Shanghai Zhongshan Hospital (Other), West China Hospital (Other), Shenzhen People's Hospital (Other)
• Enrollment: 204
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 10.8
• Patients Per Site: 68
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Vascular Disease Occlusive	Procedure: VRS100 robotic-assisted PCI; Procedure: Manual PCI	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 204 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Anticipated Study Start Date: Sep 8, 2023
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VRS100 robotic-assisted PCI VRS100 robotic-assisted PCI	Procedure: 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.
Active Comparator: Manual PCI Manual PCI	Procedure: Manual PCI; Use the traditional technique of manually advancing intracoronary guidewires, balloons, and stents at the patient's tableside.

Outcome Measures

Primary Outcome Measures

1. 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).

2. Technical Success [1 day]

   Defined as the successful advancement and retraction of PCI devices using the VRS100 System and without conversion to manual operation.

Secondary Outcome Measures

1. PCI Procedure Time [During procedure]

   Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.

2. Overall Procedure Time [During procedure]

   Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.

3. Fluoroscopy and/or X-Ray Time [During procedure]

   As recorded by an X-Ray System utilized during the procedure.

4. Patient Radiation Exposure - Cumulative Dose [During procedure]

   Cumulative dose (mGy) as recored during the procedure.

5. Contrast Fluid Volume [During procedure]

   The amount of contrast fluid used (mL) during the procedure.

6. Performance of the Experimental Device [During procedure]

   The frequency of failures and performance evaluation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shenzhen People's Hospital	Shenzhen	Guangdong	China	518020
2	Zhongshan Hospital	Shanghai	Shanghai	China	200032
3	West China Hospital of Sichuan University	Chengdu	Sichuang	China	610041

Sponsors and Collaborators

• Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
• Shanghai Zhongshan Hospital
• West China Hospital
• Shenzhen People's Hospital

Investigators

• Study Director: Junbo Ge, Shanghai Zhongshan Hospital
• Principal Investigator: Yong He, West China Hospital
• Principal Investigator: Da Yin, Shenzhen People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
• ClinicalTrials.gov Identifier: NCT06032572
• Other Study ID Numbers: VRS100 System
• First Posted: Sep 13, 2023
• Last Update Posted: Sep 13, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Vascular Diseases; Arteriosclerosis; Ischemia

Study Results

No Results Posted as of Sep 13, 2023