Wedge NC - Scoring Balloon Dilatation Catheter

NCT06214247 | Completed

• 1 other identifier: 814
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 11

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Clinical Success Rate

  30-day follow-up after procedure

• Device Procedural Success Rate

  Immediately after procedure

• Minimum Luminal Diameter (MLD)

  Immediately after procedure

• Percent of Diameter Stenosis(%DS)

  Immediately after procedure

• Acute Lumen Gain (ALG)

  Immediately after procedure

Study Arms (2)

Test Group

EXPERIMENTAL

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

Control Group

EXPERIMENTAL

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

Interventions

Wedge NC Scoring Balloon Dilatation Catheter DEVICE

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.

Test Group

Scoreflex Scoring Balloon Dilatation Catheter DEVICE

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 years old.
• 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.
• Subjects with coronary artery stenosis confirmed by imaging examination are suitable for percutaneous coronary intervention (PCI).
• Subject or a legally authorized representative must provide written informed consent prior to any study related procedures.
• Subject must have de novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis suitable for percutaneous coronary intervention.
• Target lesion with reference vessel diameter (RVD) of 2.0mm - 4.0mm, length ≤30mm (by visual inspection).
• 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.
• If target lesions and non-target lesions are treated simultaneously, they must be located in different coronary artery from the Target lesion

You may not qualify if:

• Subjects with bleeding tendency, contraindications to antiplatelet agent and anticoagulant therapy, and inability to anticoagulant therapy.
• Subjects are sensitivity to contrast media which cannot be adequately pre-medicated.
• 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.
• Subjects with decompensated congestive heart failure or cardiogenic shock.
• Subjects with expected life less than 12 months.
• Subjects with an active peptic ulcer or active gastrointestinal bleeding within 1 month prior to index procedure.
• Subjects with an embolic stroke or transient ischemic attack within 2 months prior to index procedure.
• Subject with known pregnancy or is nursing. Women of child-bearing potential shall undertake a pregnancy test before index procedure.
• Subjects enrolled in any other clinical trial within 1 month prior to the trial or currently.
• Subjects who have poor compliance and cannot complete the trial as required.
• Lesions with total coronary artery occlusion (TIMI 0 or 1).
• Severe calcifications (grade Ⅲ-Ⅳ) or extreme angulation (\>90°), etc., and lesions are inability to pass the study balloon or stent.
• Lesions with visible thrombosis or ulcers.
• Lesions with significant intima tears.
• Unprotected left main disease.

Sponsors & Collaborators

• BrosMed Medical Co., Ltd: lead

Study Sites (11)

Dongguan People's Hospital

Dongguan, Guangdong, China

Location

Dongguan Tongwah Hospital

Dongguan, Guangdong, China

Location

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Affiliated Hangzhou First People's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Huzhou Central Hospital

Huzhou, Zhejiang, China

Location

Ningbo First Hospital

Ningbo, Zhejiang, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

Wenzhou People's Hospital

Wenzhou, Zhejiang, China

Location

Related Publications (1)

• Chen H, Xu J, Chen D, Gao F, Liu Y, Cui H, Wang J, Guo S, Du Z, Huang J, Zhang X, Jiang W, Cheng Z, Jiang J. Randomized study assessing the effectiveness and safety of a novel scoring balloon for percutaneous coronary intervention: the Wedge NC trial. J Thorac Dis. 2025 Apr 30;17(4):2101-2112. doi: 10.21037/jtd-24-1457. Epub 2025 Apr 27.

  PMID: 40400945 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jian'an Wang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 19, 2024
• Study Start: August 27, 2021
• Primary Completion: February 28, 2022
• Study Completion: May 17, 2022
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)