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Coronary ArteriosclerosisNCT05929313

Scoreflex TRIO - Scoring PTCA Catheter

A study testing OrbusNeich Scoreflex TRIO and OrbusNeich Scoreflex NC in people with Coronary Arteriosclerosis, run by OrbusNeich at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the acute safety and device procedural success of the Scoreflex TRIO Scoring PTCA catheters versus Scoreflex NC Scoring PTCA catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Arteriosclerosis
What is being tested?
OrbusNeich Scoreflex TRIO and OrbusNeich Scoreflex NC
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
4 sitesChina
Study dates
27 Apr 2023to 29 May 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 and≤ 80.
  • Volunteer to participate in this trial and provide the written informed consent.
  • Subjects must have a single or double vessel coronary artery disease (CAD) and clinical evidence of ischemic heart disease, such as CAD, stable / unstable angina or silent ischemia, need percutaneous coronary intervention.
  • Angiographic Inclusion Criteria
  • Subject must have de novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis suitable for percutaneous coronary intervention.
  • A maximum of two lesions that needed to be treated and they are located in two coronary arteries, including at least one target lesion, in up to two coronary arteries.
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  • Target lesion must have a reference vessel diameter (RVD) between 1.75 and 4.0 mm by visual estimation.
  • Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation.
  • The non-target lesion must be located in different coronary artery from the Target lesion. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician.

Who cannot join

  • STEMI or NSTEMI within 7 days of study screening.
  • A serum creatinine level > 2.0 mg/dl within 7 days prior to index procedure.
  • Cerebrovascular accident (CVA) within the past 6 months.
  • Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months.
  • Left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary)
  • Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications,
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  • Subject is known to be allergic to the ingredients of the test product and the sensitivity to contrast media.
  • Subject with known pregnancy or is nursing. Women of child-bearing potential should have a documented negative pregnancy test within 7 days before index procedure.
  • Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure.
  • Subjects who are participating in clinical research of other drugs and devices.
  • Other conditions assessed by the investigator as inappropriate to participate in this trial.
  • Angiographic Exclusion Criteria
  • Target lesion longer than 30 mm by visual estimation.
  • Extreme angulation (90º or greater) proximal to or within the target lesion.
  • Target lesion located within an arterial or saphenous vein graft or graft anastomosis
  • Previous percutaneous intervention of lesions in a target vessel (including side branches) conducted within 9 months before the study procedure and located within 10 mm from the current target lesion.
  • Target lesion demonstrating severe dissection prior to planned deployment of the investigational device.
  • Unprotected left main coronary artery disease.
  • Coronary artery spasm of the target vessel in the absence of a significant stenosis.
  • Target lesion with angiographic presence of probable or definite thrombus.
  • Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.0 mm in diameter.
  • Non-target lesion to be treated during the index procedure meets any of the following criteria:
  • Located within a bypass graft (venous or arterial)
  • Left main location
  • Chronic total occlusion
  • Involves a bifurcation (e.g., bifurcations requiring treatment with more than 1 stent)
  • Treatment not deemed a clinical angiographic success

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Tong Ren Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai

  • Zhongshan Hospital Fudan University

    Shanghai

Other trials in China

About this study

Official title: A Prospective, Multicenter, Randomized Controlled, Non- Inferiority Trial to Evaluate the Effectiveness and Safety of the Scoreflex TRIO High-pressure Tri-wire Scoring Balloon Catheter for Balloon Dilatation of Coronary Artery Stenosis

To evaluate the acute safety and device procedural success of the Scoreflex TRIO Scoring PTCA catheters versus Scoreflex NC Scoring PTCA catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention.

Read the detailed description

This is a prospective, multi-center, open-label, non-inferiority, randomized controlled trial which plans to enroll 210 subjects. All subjects enrolled will be randomly assigned to the test group (n=105) and the control group (n=105). Subjects in the test group and the control group will receive Scoreflex TRIO Scoring PTCA catheters and Scoreflex NC Scoring PTCA catheters respectively.

Being tested
OrbusNeich Scoreflex TRIO, OrbusNeich Scoreflex NC
Keywords
Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases
Medical subject headings
Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases

What participants receive

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

  • OrbusNeich Scoreflex TRIODevice

    To dilate coronary arteries during the subject's index procedure with Scoreflex TRIO Scoring PTCA catheters

  • OrbusNeich Scoreflex NCDevice

    To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters

Study groups in NCT05929313
Study groupRoleWhat they receive
OrbusNeich Scoreflex TRIOExperimentalOrbusNeich Scoreflex TRIO Scoring PTCA catheters
Receives: Device: OrbusNeich Scoreflex TRIO
OrbusNeich Scoreflex NCActive comparatorOrbusNeich Scoreflex NC Scoring PTCA catheters
Receives: Device: OrbusNeich Scoreflex NC

What is being measured

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

  1. Rate of device Procedural Success

    Device procedural success consisting of the following:

    • Successful delivery, inflation, deflation, and withdrawal of the device
    • No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in Thrombolysis In Myocardial Infarction (TIMI) flow from baseline as related to the devices
    • Residual stenosis of target lesion <50% after balloon angioplasty, Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention (PCI) procedure

    Measured: Peri-procedural (at Day 0)

Secondary outcomes (4)

  1. Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA).

    Improvement in MLD is defined as MLD post use of Scoreflex as greater than MLD from baseline.

    Measured: Peri-procedural (at Day 0)

  2. In-hospital Major Adverse Cardiac Events (MACE)

    In-hospital Major Adverse Cardiac Events (MACE), a composite of: Cardiac death, Myocardial Infarction (MI), Target Lesion Revascularization (TLR), clinically driven.

    Measured: Endpoints will be measured through hospital discharge (expected to be within 24 hours)

  3. Device-oriented target lesion failure (TLF)

    The device-oriented target lesion failure (TLF) is defined as a composite of cardiac death, target vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization (i-TLR)

    Measured: 30 days

  4. Patient-oriented composite endpoint

    The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularization.

    Measured: 30 days

Timeline

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

  1. First posted3 Jul 2023
  2. Study start27 Apr 2023
  3. Primary completion30 Apr 2024
  4. Study completion29 May 2024

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
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05929313
Sponsor's protocol ID
SFT-2022-001
Status last verified
Aug 2024
First submitted
23 Jun 2023
Last updated
26 Aug 2024
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 OrbusNeich Scoreflex TRIO and OrbusNeich Scoreflex NC in people with Coronary Arteriosclerosis, run by OrbusNeich at 4 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 9 inclusion and 27 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: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of device Procedural Success (time frame: Peri-procedural (at Day 0)). 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 NCT05929313.

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 26 Aug 2024.

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