Clinical trial NCT05929313: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Arteriosclerosis
Keywords: Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Cardiovascular Diseases
Lead sponsor: OrbusNeich
Sponsor class: INDUSTRY
Collaborators: name: CCRC Medtech (Shanghai) Co., Ltd.
First posted: 2023-07-03
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of device Procedural Success
timeFrame: Peri-procedural (at Day 0)
Secondary outcomes:
measure: Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA).
timeFrame: Peri-procedural (at Day 0)
measure: In-hospital Major Adverse Cardiac Events (MACE)
timeFrame: Endpoints will be measured through hospital discharge (expected to be within 24 hours)
measure: Device-oriented target lesion failure (TLF)
timeFrame: 30 days
measure: Patient-oriented composite endpoint
timeFrame: 30 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Shanghai
country: China
facility: Tong Ren Hospital Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
Study officials:
affiliation: Fudan University
name: Jun Bo Ge, MD
role: PRINCIPAL_INVESTIGATOR
References: