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Coronary Artery DiseaseNCT06032572

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

A study testing VRS100 robotic-assisted PCI and Manual PCI in people with Coronary Artery Disease and Cardiovascular Diseases, run by Shenzhen Raysight Intelligent Medical Technology Co., Ltd. at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VRS100 robotic-assisted PCI and Manual PCI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
3 sitesChina
Study dates
8 Sep 2023to 1 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria:
  • Age ≥18 years.
  • Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI).
  • The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
  • Angiographic Inclusion Criteria:
  • In situ primary coronary vascular disease.
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  • Reference vessel diameter is 2.5-4.0mm by visual estimate.
  • Target lesion length is ≤30.0mm.
  • 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.
  • Target lesion diameter showing stenosis ≥70% by visual estimate, or ≥50% with myocardial ischemia.

Who cannot join

  • Patients meeting any of the following criteria will be excluded:
  • General Exclusion Criteria:
  • Subjects with indications for urgent PCI surgery.
  • Evidence of an acute myocardial infarction within one week prior to the intended VRS100 procedure.
  • Subject has undergone PCI within 72 hours prior to the VRS100 procedure.
  • Subject has undergone PCI within 30 days prior to the VRS100 procedure and experienced a MACE or a serious adverse event (SAE).
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  • Severe heart failure (NYHA IV).
  • Subject has suffered a stroke, or has an active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to planned VRS100 procedure.
  • Subject has known hypersensitivity or contraindication to aspirin, heparin, ticagrelor, clopidogrel, bivalirudin, PTX(paclitaxel), stainless steel, etc.
  • Subject has acute or chronic kidney disease (serum creatinine level of >2.5 mg/dL or >221 umol/L) or need dialysis.
  • Pregnant or breastfeeding, or planning to be pregnant.
  • Repeated enrollment.
  • Any other factors that the researchers consider not suitable for inclusion or completion of this study.
  • Angiographic Exclusion Criteria:
  • Any previous stent placement within 5.0 mm (proximal or distal) of the target lesion.
  • 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.
  • Cardiac allograft vasculopathy (CAV).
  • The study vessel has evidence of intraluminal thrombus.
  • Chronic total occlusion (CTO).
  • The study lesion located in a native vessel distal to an ostial, bifurcation or anastomosis.
  • Unprotected left main coronary artery disease defined as an obstruction greater than 50% diameter stenosis in the left main coronary artery.
  • The study lesion or vessel proximal to the target lesion has severe tortuosity or calcification.
  • Target lesion that cannot be fully covered by a single stent.
  • more than 2 lesions requires treatment in one vessel.
  • Subject requires treatment of more than one vessel.

Trial locations and contacts

3 sites in 1 country.

Lihui Li contact

13636480344

lihui.li@raysightmed.com

China3 sites

  • West China Hospital of Sichuan University

    Chengdu, Sichuang, 610041

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020

Other trials in China

About this study

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)

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).

Being tested
VRS100 robotic-assisted PCI, Manual PCI
Medical subject headings
Coronary Artery Disease, Cardiovascular Diseases, Coronary Disease, Myocardial Ischemia, Arteriosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VRS100 robotic-assisted PCIProcedure or surgery

    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 PCIProcedure or surgery

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

Study groups in NCT06032572
Study groupRoleWhat they receive
VRS100 robotic-assisted PCIExperimentalVRS100 robotic-assisted PCI
Receives: Procedure: VRS100 robotic-assisted PCI
Manual PCIActive comparatorManual PCI
Receives: Procedure: Manual PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Success

    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).

    Measured: 48-hrs or hospital discharge, whichever occurs first

  2. Technical Success

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

    Measured: 1 day

Secondary outcomes (6)

  1. PCI Procedure Time

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

    Measured: During procedure

  2. Overall Procedure Time

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

    Measured: During procedure

  3. Fluoroscopy and/or X-Ray Time

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

    Measured: During procedure

  4. Patient Radiation Exposure - Cumulative Dose

    Cumulative dose (mGy) as recored during the procedure.

    Measured: During procedure

  5. Contrast Fluid Volume

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

    Measured: During procedure

  6. Performance of the Experimental Device

    The frequency of failures and performance evaluation

    Measured: During procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2023
  2. Study start8 Sep 2023 (estimated)
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion1 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
204 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06032572
Sponsor's protocol ID
VRS100 System
Status last verified
Sep 2023
First submitted
4 Sep 2023
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing VRS100 robotic-assisted PCI and Manual PCI in people with Coronary Artery Disease and Cardiovascular Diseases, run by Shenzhen Raysight Intelligent Medical Technology Co., Ltd. at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lihui Li (13636480344, lihui.li@raysightmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Success (time frame: 48-hrs or hospital discharge, whichever occurs first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06032572.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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