Wedge NC - Scoring Balloon Dilatation Catheter

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06214247
• Other study ID #: 814
• Status: Completed
• Phase: N/A
• Start date: August 27, 2021
• Est. completion date: May 17, 2022

Study information

• Verified date: January 2024
• Source: BrosMed Medical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: May 17, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?-?) 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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Dongguan People's Hospital	Dongguan	Guangdong
China	Dongguan Tongwah Hospital	Dongguan	Guangdong
China	Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Affiliated Hospital of Hangzhou Normal University	Hangzhou	Zhejiang
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Huzhou Central Hospital	Huzhou	Zhejiang
China	Ningbo First Hospital	Ningbo	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	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
BrosMed Medical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Minimum Luminal Diameter (MLD)	The minimal diameter of the target lesion, evaluated by quantitative coronary analysis (QCA).	Immediately after procedure
Secondary	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
Secondary	Acute Lumen Gain (ALG)	ALG = immediately postoperative MLD - preoperative MLD	Immediately after procedure
Secondary	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
Secondary	Surgical complication	Incidence of Complications in a Single Operation	Day 0
Secondary	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