Wedge NC - Scoring Balloon Dilatation Catheter

BrosMed Medical

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Scoreflex Scoring Balloon Dilatation Catheter; Device: Wedge NC Scoring Balloon Dilatation Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT06214247

814

Details and patient eligibility

About

To evaluate the efficacy and safety of Wedge NC Scoring Balloon Dilatation Catheter for dilating coronary stenosis during PCI in comparison with a similar product on the market.

Full description

The prospective, multicenter, open-label, randomized clinical study is designed to verify the efficacy and safety of Wedge NC Scoring Balloon Dilatation Catheter in the application of dilatating coronary artery stenosis during PCI in comparison with a similar product on the market. The study is planned to enroll 198 subjects, who are randomly assigned to the test group (99 cases) and the control group (99 cases).

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age≥18 years old.
2. 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.
3. Subjects with coronary artery stenosis confirmed by imaging examination are suitable for percutaneous coronary intervention (PCI).
4. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures.
5. Subject must have de novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis suitable for percutaneous coronary intervention.
6. Target lesion with reference vessel diameter (RVD) of 2.0mm - 4.0mm, length ≤30mm (by visual inspection).
7. Only one lesion will be selected as the target lesion for revascularization when subjects have multiple lesions requiring treatment. Tandem lesions (defined as multiple lesions) are deemed one lesion if they can be covered by a single stent.
8. If target lesions and non-target lesions are treated simultaneously, they must be located in different coronary artery from the Target lesion

Exclusion criteria

1. Subjects with bleeding tendency, contraindications to antiplatelet agent and anticoagulant therapy, and inability to anticoagulant therapy.
2. Subjects are sensitivity to contrast media which cannot be adequately pre-medicated.
3. Subjects with severe renal failure, whether on dialysis or not, with a glomerular filtration rate (eGFR) level < 30ml/min/1.73m2 or serum creatinine level> 2.0 mg/dl within 7 days prior to index procedure.
4. Subjects with decompensated congestive heart failure or cardiogenic shock.
5. Subjects with expected life less than 12 months.
6. Subjects with an active peptic ulcer or active gastrointestinal bleeding within 1 month prior to index procedure.
7. Subjects with an embolic stroke or transient ischemic attack within 2 months prior to index procedure.
8. Subject with known pregnancy or is nursing. Women of child-bearing potential shall undertake a pregnancy test before index procedure.
9. Subjects enrolled in any other clinical trial within 1 month prior to the trial or currently.
10. Subjects who have poor compliance and cannot complete the trial as required.
11. Lesions with total coronary artery occlusion (TIMI 0 or 1).
12. Severe calcifications (grade Ⅲ-Ⅳ) or extreme angulation (>90°), etc., and lesions are inability to pass the study balloon or stent.
13. Lesions with visible thrombosis or ulcers.
14. Lesions with significant intima tears.
15. Unprotected left main disease.
16. Lesions located within an artery/saphenous vein graft or graft anastomosis.
17. Coronary artery spasm without significant stenosis.
18. Saphenous vein graft degenerative disease
19. Other situations that the investigator considers inappropriate for participation in this trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 2 patient groups

Test Group

Experimental group

Description:

During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using the Wedge NC Scoring Balloon Dilatation Catheter in the test group, subsequently completing the remaining procedure.

Treatment:

Device: Wedge NC Scoring Balloon Dilatation Catheter

Control Group

Experimental group

Description:

During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using a similar product(Scoring Balloon Dilatation Catheter) on the market in the control group, subsequently completing the remaining procedure.

Treatment:

Device: Scoreflex Scoring Balloon Dilatation Catheter