Wedge NC - Scoring Balloon Dilatation Catheter

A Prospective, Open Label, Multi-center, Randomized Study Designed to Evaluate the Safety and Efficacy of Scoring PTCA Catheter on Subjects During Percutaneous Coronary Intervention

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Wedge NC Scoring Balloon Dilatation Catheter; Device: Scoreflex Scoring Balloon Dilatation Catheter

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Dongguan, Guangdong, China
      • Dongguan People's Hospital
    • Dongguan, Guangdong, China
      • Dongguan Tongwah Hospital
    • Guangzhou, Guangdong, China
      • Sun Yat-sen Memorial Hospital of Sun Yat-sen University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • the Second Affiliated Hospital Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • The affiliated hospital of Hangzhou Normal University
    • Hangzhou, Zhejiang, China
      • Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine
    • Huzhou, Zhejiang, China
      • Huzhou Central Hospital
    • Ningbo, Zhejiang, China
      • Ningbo First Hospital
    • Wenzhou, Zhejiang, China
      • The First Affiliated Hospital of Wenzhou Medical University
    • Wenzhou, Zhejiang, China
      • The Second Affiliated Hospital of Wenzhou Medical University
    • Wenzhou, Zhejiang, China
      • Wenzhou People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; 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.	Device: Wedge NC Scoring Balloon Dilatation Catheter; 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.
Experimental: Control Group; 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.	Device: Scoreflex Scoring Balloon Dilatation Catheter; During PCI, percutaneous transluminal coronary angioplasty is performed on the target lesion using a similar product on the market in the control group, subsequently completing the remaining procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Success Rate	Procedure success is defined as the target lesion residual stenosis ≤30% right after PCI, without death, Q-wave or non-Q-wave myocardial infarction, or emergency coronary artery bypass grafting (CABG) during postoperative hospitalization.	before discharge or within 3 days after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success Rate	Clinical success is defined as the composite endpoint of no Major Adverse Cardiovascular Events (MACE) at follow-up, including cardiac death (also considered cardiac death if the cause of death is uncertain), target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR)	30-day follow-up after procedure
Device Procedural Success Rate	The following conditions need to be met for the successful balloon dilatation of stenotic lesions: Successful delivery, inflation, deflation, and withdrawal of the study balloon.; 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 study balloon	Immediately after procedure
Minimum Luminal Diameter (MLD)	The minimal diameter of the target lesion, evaluated by quantitative coronary analysis (QCA).	Immediately after procedure
Percent of Diameter Stenosis(%DS)	%DS = (RVD - MLD) / RVD × 100%, MLD refers to the immediately postoperative minimum luminal diameter, RVD refers to the reference vessel diameter.	Immediately after procedure
Acute Lumen Gain (ALG)	ALG = immediately postoperative MLD - preoperative MLD	Immediately after procedure
Balloon Slippage Rate	Balloon slippage is defined as a forward or backward movement of the balloon of at least 3mm during its inflation at the lesion site	Immediately after procedure
Surgical complication	Incidence of Complications in a Single Operation	Day 0
Rate of Adverse Events	Adverse events include death (cardiogenic death or non-cardiogenic death), acute myocardial infarction (Q wave or non-Q wave), target lesion revascularization (TLR), target vessel revascularization (TVR), other cardiac surgery and other cardiac adverse events, etc	Month 3

Collaborators and Investigators

• Sponsor: BrosMed Medical Co., Ltd
• Investigators: Principal Investigator: Jian'an Wang, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): May 17, 2022

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Estimated): January 19, 2024

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 814

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