Clinical trial NCT06214247: Wedge NC - Scoring Balloon Dilatation Catheter
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: BrosMed Medical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-19
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Procedure Success Rate
timeFrame: before discharge or within 3 days after the procedure
Secondary outcomes:
measure: Clinical Success Rate
timeFrame: 30-day follow-up after procedure
measure: Device Procedural Success Rate
timeFrame: Immediately after procedure
measure: Minimum Luminal Diameter (MLD)
timeFrame: Immediately after procedure
measure: Percent of Diameter Stenosis(%DS)
timeFrame: Immediately after procedure
measure: Acute Lumen Gain (ALG)
timeFrame: Immediately after procedure
measure: Balloon Slippage Rate
timeFrame: Immediately after procedure
measure: Surgical complication
timeFrame: Day 0
measure: Rate of Adverse Events
timeFrame: Month 3
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan People's Hospital
state: Guangdong
city: Dongguan
country: China
facility: Dongguan Tongwah Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Affiliated Hospital of Hangzhou Normal University
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou People's Hospital
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jian'an Wang
role: PRINCIPAL_INVESTIGATOR
References: