Scoreflex TRIO - Scoring PTCA Catheter

OrbusNeich

Status: Completed

Conditions: Coronary Arteriosclerosis

Treatments: Device: OrbusNeich Scoreflex TRIO; Device: OrbusNeich Scoreflex NC

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05929313

SFT-2022-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

OrbusNeich Scoreflex TRIO

Experimental group

Description:

OrbusNeich Scoreflex TRIO Scoring PTCA catheters

Treatment:

Device: OrbusNeich Scoreflex TRIO

OrbusNeich Scoreflex NC

Active Comparator group

Description:

OrbusNeich Scoreflex NC Scoring PTCA catheters

Treatment:

Device: OrbusNeich Scoreflex NC