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Scoreflex TRIO - Scoring PTCA Catheter

Primary Purpose

Coronary Arteriosclerosis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
OrbusNeich Scoreflex TRIO
OrbusNeich Scoreflex NC
Sponsored by
OrbusNeich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Arteriosclerosis focused on measuring Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 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. Exclusion Criteria: 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, 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

Sites / Locations

  • Sir Run Run Shaw Hospital Zhejiang University School of MedicineRecruiting
  • The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
  • Tong Ren Hospital Shanghai Jiao Tong University School of MedicineRecruiting
  • Zhongshan Hospital Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OrbusNeich Scoreflex TRIO

OrbusNeich Scoreflex NC

Arm Description

OrbusNeich Scoreflex TRIO Scoring PTCA catheters

OrbusNeich Scoreflex NC Scoring PTCA catheters

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 23, 2023
Last Updated
June 23, 2023
Sponsor
OrbusNeich
Collaborators
CCRC Medtech (Shanghai) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05929313
Brief Title
Scoreflex TRIO - Scoring PTCA Catheter
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OrbusNeich
Collaborators
CCRC Medtech (Shanghai) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis
Keywords
Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OrbusNeich Scoreflex TRIO
Arm Type
Experimental
Arm Description
OrbusNeich Scoreflex TRIO Scoring PTCA catheters
Arm Title
OrbusNeich Scoreflex NC
Arm Type
Active Comparator
Arm Description
OrbusNeich Scoreflex NC Scoring PTCA catheters
Intervention Type
Device
Intervention Name(s)
OrbusNeich Scoreflex TRIO
Intervention Description
To dilate coronary arteries during the subject's index procedure with Scoreflex TRIO Scoring PTCA catheters
Intervention Type
Device
Intervention Name(s)
OrbusNeich Scoreflex NC
Intervention Description
To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
Primary Outcome Measure Information:
Title
Rate of device Procedural Success
Description
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
Time Frame
Peri-procedural (at Day 0)
Secondary Outcome Measure Information:
Title
Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA).
Description
Improvement in MLD is defined as MLD post use of Scoreflex as greater than MLD from baseline.
Time Frame
Peri-procedural (at Day 0)
Title
In-hospital Major Adverse Cardiac Events (MACE)
Description
In-hospital Major Adverse Cardiac Events (MACE), a composite of: Cardiac death, Myocardial Infarction (MI), Target Lesion Revascularization (TLR), clinically driven.
Time Frame
Endpoints will be measured through hospital discharge (expected to be within 24 hours)
Title
Device-oriented target lesion failure (TLF)
Description
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)
Time Frame
30 days
Title
Patient-oriented composite endpoint
Description
The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularization.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gun Bo Ge, MD
Phone
13901977506
Email
ge.junbo@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gun Bo Ge, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo Sheng Fu, MD
Phone
13605800707
Email
fugslh@126.com
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian An Wang, MD
Phone
13805786328
Email
wja@zju.edu.cn
Facility Name
Tong Ren Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Hui Qui, MD
Phone
13916765005
Email
zhaohui_qiu@hotmail.com
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gun Bo Ge, MD
Phone
13901977506
Email
ge.junbo@zs-hospital.sh.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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Scoreflex TRIO - Scoring PTCA Catheter

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