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Coronary Artery DiseaseNCT06214247

Wedge NC - Scoring Balloon Dilatation Catheter

A study testing Wedge NC Scoring Balloon Dilatation Catheter and Scoreflex Scoring Balloon Dilatation Catheter in people with Coronary Artery Disease, run by BrosMed Medical Co., Ltd at 11 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Wedge NC Scoring Balloon Dilatation Catheter and Scoreflex Scoring Balloon Dilatation Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
11 sitesChina
Study dates
27 Aug 2021to 17 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.
  • Lesions located within an artery/saphenous vein graft or graft anastomosis.
  • Coronary artery spasm without significant stenosis.
  • Saphenous vein graft degenerative disease
  • Other situations that the investigator considers inappropriate for participation in this trial.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Dongguan People's Hospital

    Dongguan, Guangdong

  • Dongguan Tongwah Hospital

    Dongguan, Guangdong

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

    Guangzhou, Guangdong

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

    Hangzhou, Zhejiang

  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, Zhejiang

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Huzhou Central Hospital

    Huzhou, Zhejiang

  • Ningbo First Hospital

    Ningbo, Zhejiang

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Wenzhou People's Hospital

    Wenzhou, Zhejiang

Other trials in China

About this study

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

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.

Read the 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).

Being tested
Wedge NC Scoring Balloon Dilatation Catheter, Scoreflex Scoring Balloon Dilatation Catheter
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wedge NC Scoring Balloon Dilatation CatheterDevice

    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 CatheterDevice

    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.

Study groups in NCT06214247
Study groupRoleWhat they receive
Test GroupExperimentalDuring 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.
Receives: Device: Wedge NC Scoring Balloon Dilatation Catheter
Control GroupExperimentalDuring 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.
Receives: Device: Scoreflex Scoring Balloon Dilatation Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: before discharge or within 3 days after the procedure

Secondary outcomes (8)

  1. 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)

    Measured: 30-day follow-up after procedure

  2. Device Procedural Success Rate

    The following conditions need to be met for the successful balloon dilatation of stenotic lesions:

    1. Successful delivery, inflation, deflation, and withdrawal of the study balloon.
    2. 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

    Measured: Immediately after procedure

  3. Minimum Luminal Diameter (MLD)

    The minimal diameter of the target lesion, evaluated by quantitative coronary analysis (QCA).

    Measured: Immediately after procedure

  4. 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.

    Measured: Immediately after procedure

  5. Acute Lumen Gain (ALG)

    ALG = immediately postoperative MLD - preoperative MLD

    Measured: Immediately after procedure

  6. 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

    Measured: Immediately after procedure

  7. Surgical complication

    Incidence of Complications in a Single Operation

    Measured: Day 0

  8. 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

    Measured: Month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2024
  2. Study start27 Aug 2021
  3. Primary completion28 Feb 2022
  4. Study completion17 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06214247
Sponsor's protocol ID
814
Status last verified
Jan 2024
First submitted
8 Jan 2024
Last updated
19 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40400945

Questions about this trial

What is this clinical trial studying?

A study testing Wedge NC Scoring Balloon Dilatation Catheter and Scoreflex Scoring Balloon Dilatation Catheter in people with Coronary Artery Disease, run by BrosMed Medical Co., Ltd at 11 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedure Success Rate (time frame: before discharge or within 3 days after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06214247, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.

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