Scoreflex TRIO - Scoring PTCA Catheter

August 23, 2024 updated by: OrbusNeich

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
210

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Shanghai, China
        • Zhongshan Hospital Fudan University
      • Shanghai, China
        • Tong Ren Hospital Shanghai Jiao Tong University school of medicine
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China
        • The Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 and≤ 80.
  2. Volunteer to participate in this trial and provide the written informed consent.

  3. 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

  4. Subject must have de novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis suitable for percutaneous coronary intervention.
  5. 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.
  6. Target lesion must have a reference vessel diameter (RVD) between 1.75 and 4.0 mm by visual estimation.
  7. Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation.
  8. 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.

Exclusion Criteria:

  1. STEMI or NSTEMI within 7 days of study screening.
  2. A serum creatinine level > 2.0 mg/dl within 7 days prior to index procedure.
  3. Cerebrovascular accident (CVA) within the past 6 months.
  4. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months.
  5. Left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary)
  6. Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications,
  7. Subject is known to be allergic to the ingredients of the test product and the sensitivity to contrast media.
  8. 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.
  9. Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure.
  10. Subjects who are participating in clinical research of other drugs and devices.

  11. Other conditions assessed by the investigator as inappropriate to participate in this trial.

    Angiographic Exclusion Criteria

  12. Target lesion longer than 30 mm by visual estimation.
  13. Extreme angulation (90º or greater) proximal to or within the target lesion.
  14. Target lesion located within an arterial or saphenous vein graft or graft anastomosis
  15. 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.
  16. Target lesion demonstrating severe dissection prior to planned deployment of the investigational device.
  17. Unprotected left main coronary artery disease.
  18. Coronary artery spasm of the target vessel in the absence of a significant stenosis.
  19. Target lesion with angiographic presence of probable or definite thrombus.
  20. Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.0 mm in diameter.

  21. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OrbusNeich Scoreflex TRIO
OrbusNeich Scoreflex TRIO Scoring PTCA catheters
Device: OrbusNeich Scoreflex TRIO
To dilate coronary arteries during the subject's index procedure with Scoreflex TRIO Scoring PTCA catheters
Active Comparator: OrbusNeich Scoreflex NC
OrbusNeich Scoreflex NC Scoring PTCA catheters
Device: OrbusNeich Scoreflex NC
To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of device Procedural Success
Time Frame: Peri-procedural (at Day 0)

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
Peri-procedural (at Day 0)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA).
Time Frame: Peri-procedural (at Day 0)
Improvement in MLD is defined as MLD post use of Scoreflex as greater than MLD from baseline.
Peri-procedural (at Day 0)
In-hospital Major Adverse Cardiac Events (MACE)
Time Frame: Endpoints will be measured through hospital discharge (expected to be within 24 hours)
In-hospital Major Adverse Cardiac Events (MACE), a composite of: Cardiac death, Myocardial Infarction (MI), Target Lesion Revascularization (TLR), clinically driven.
Endpoints will be measured through hospital discharge (expected to be within 24 hours)
Device-oriented target lesion failure (TLF)
Time Frame: 30 days
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)
30 days
Patient-oriented composite endpoint
Time Frame: 30 days
The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularization.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
OrbusNeich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CCRC Medtech (Shanghai) Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jun Bo Ge, MD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SFT-2022-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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