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Coronary Artery DiseaseNCT04953117

A Safety and Efficacy Study of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease

A study testing DCB of Lepu Medical(dimeter≥2.00 mm), Restore DEB and DCB of Lepu Medical(dimeter<2.00 mm) in people with Coronary Artery Disease, run by Lepu Medical Technology (Beijing) Co., Ltd. at 14 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study was designed to verify the safety and efficacy of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
DCB of Lepu Medical(dimeter≥2.00 mm), Restore DEB and DCB of Lepu Medical(dimeter<2.00 mm)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
286 participants
Where
14 sitesChina
Study dates
10 Mar 2021to Apr 2023
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age must be 18-80 years, males or females.
  • Subject with stable angina, or unstable angina, or recent myocardial infarction (myocardial infarction occurred more than 7 days before enrolled into the group), or asymptomatic myocardial ischemia with evidence
  • Coronary angiopathy in situ with stenosis of more than 70% with visually estimated (or more than 50% combined with symptoms of ischemia, TIMI ≥ 1) in a vessel with visually estimated reference vessel diameter (RVD) ≥ 2.0 mm and ≤ 2.75 mm in small vessel group,and ≤ 26 mm in length or RVD ≥ 1.75 mm and < 2.0 mm in very small vessel group, and ≤ 16 mm in length.
  • Target small vessel lesions are located on one or two different coronary arteries (RCA / LAD/ LCX). The number of target small vessel lesions on each coronary artery is no more than one, and each target small vessel lesion can only be treated with one test instrument
  • The number of non-target lesions requiring early interventional treatment is no more than two, and the distance between them and target lesions must be > 10 mm; Successful treatment of non target lesions is required before subjects are randomized and the test equipment(DCB) cannot be used for the treatment.
  • Subject can receive any type of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
  • Subject can understand the study objectives and voluntarily participate in and sign the informed consent; subject must agree to clinical follow-up and angiographic follow-up at 9 months.

Who cannot join

  • AMI within 1 week.
  • In stent restenosis, complete occlusion or severe calcification (unable to pre expand successfully with balloon)
  • Left main artery disease or bifurcation disease with diameter >2.00mm requiring interventional treatment
  • Evidence of massive thrombi in the target vessels
  • Severe heart failure (NYHA IV)
  • Severe renal failure (subject with GFR < 30ml / min or undergoing hemodialysis)
Show all 14Show fewer
  • Subject with vein graft restenosis after bypass surgery or severe heart valve disease
  • Pregnant or nursing subjects
  • Life expectancy less than 12 months
  • Subject with bleeding tendency, history of active peptic ulcer, suffered stroke within the past 6 months, contraindications of antiplatelet preparation and anticoagulant treatment
  • Subject is currently participating in another investigational drug or device study that has not yet completed its primary endpoint.
  • Subject has undergone heart transplantation
  • Known allergy to aspirin, clopidogrel, heparin, contrast media, and paclitaxel.
  • The investigator judged that the subject's compliance is poor and can not complete the study as required.

Trial locations and contacts

14 sites in 1 country.

Ting Zhang contact

+86-010-80120666

ting_zhang@lepumedical.com

14 sites in 1 country

China14 sites, 14 recruiting

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029

    Yong Zeng

    Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100037

    Yida Tang

    Guisong Wang

    Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

    Hui Chen

    Recruiting

  • Beijing Chao-Yang Hospital, Cpaital Medical University

    Beijing, Beijing Municipality

    Lefeng Wang

    Recruiting

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality

    Qiang Tang

    Recruiting

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

    Bin Liu

    Recruiting

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang, 163411

    Hui Li

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Lianglong Chen

    Recruiting

  • Sir Run Run Shaw Hospital,School of Medicine

    Hangzhou, Zhejiang, 310016

    Guosheng Fu

    Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310058

    Jun Jiang

    Recruiting

  • Inner Mongolia People's Hospital

    Hohhot, Neimenggu, 010017

    Xi Liu

    Recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50031

    Gang Liu

    Recruiting

  • No.980 Hospital of Joint Logistics Support Force

    Shijiazhuang, Hebei, 50082

    Leisheng Ru

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

    Qing Yang

    Recruiting

Other trials in China

About this study

Official title: Assess the Safety and Efficacy of Lepu® Drug Coated Balloon Versus RESTORE® Paclitaxel Eluting Balloon for the Treatment of Coronary Small-vessel Disease: a Prospective, Multicenter, Randomized, Controlled Trial

This study was designed to verify the safety and efficacy of Lepu® Drug Coated Balloon in Treatment of Coronary Small-vessel Disease

Read the detailed description

This study include a small vessel cohort and a very small vessel cohort. In the small vessel cohort, patients with visually estimated reference vessel diameters(RVDs)≥2.0 and ≤2.75mm were randomly assigned to the Coronary Drug Coated Balloon Catheter Used in Small Vessels of Lepu Medical or the Restore DEB in a 1:1 ratio. The study was powered to detect the noninferiority of the DCB of Lepu Medical versus the Restore DEB for a primary endpoint of in-segment late lumen loss(LLL) at 9 months.

In the very small vessel cohort, patients with RVD≥1.75 and<2.0mm were treated with the DCB of Lepu Medical of an appropriate size.

All subjects will been followed up for 2 years to observe the occurrence of adverse events, so as to make an accurate and reliable evaluation of the safety of drug coated balloon catheters for coronary small vessels.

Being tested
DCB of Lepu Medical(dimeter≥2.00 mm), Restore DEB, DCB of Lepu Medical(dimeter<2.00 mm)
Keywords
Drug Coated Balloon Catheter, Small Coronary Vessel Disease, Randomized Controlled Trial
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.

  • DCB of Lepu Medical(dimeter≥2.00 mm)Device

    Also called Coronary Drug Coated Balloon Catheter of Lepu Medical for coronary small vessels

    subjects receiving DCB of Lepu Medical(dimeter≥2.00 mm)

  • Restore DEBDevice

    Also called RESTORE Paclitaxel releasing coronary balloon catheter

    subjects receiving Restore DEB

  • DCB of Lepu Medical(dimeter<2.00 mm)Device

    Also called Coronary Drug Coated Balloon Catheter of Lepu Medical for coronary very small vessels

    subjects receiving DCB of Lepu Medical(dimeter<2.00 mm)

Study groups in NCT04953117
Study groupRoleWhat they receive
small vessel cohort: DCB of Lepu MedicalExperimentalreceiving the treatment with DCB of Lepu Medical(dimeter≥2.00 mm) in small vessel cohort
Receives: Device: DCB of Lepu Medical(dimeter≥2.00 mm)
small vessel cohort:Restore DEBActive comparatorreceiving the treatment with Restore DEB in small vessel cohort
Receives: Device: Restore DEB
very small vessel cohort: DCB of Lepu MedicalOtherreceiving the treatment with DCB of Lepu Medical(dimeter<2.00 mm) in very small vessel cohort
Receives: Device: DCB of Lepu Medical(dimeter<2.00 mm)

What is being measured

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

  1. In-segment late lumen loss(LLL)

    In-segment late lumen loss is defined as the change in minimal lumen diameter

    Measured: 9 months

Secondary outcomes (6)

  1. The success rate of intervention treatment (%)(Device success,Lesion success ,Procedural success)

    The success rate of intervention treatment (%) include device success,lesion success and procedural success

    Measured: 2-3 days

  2. In-segment diameter stenosis(DS%)

    In-segment diameter stenosis(DS%) defined as (1-minimal luminal diameter[MLD]/reference vessel diameter[RVD])*100%.

    Measured: 9 months

  3. Angiographic binary restenosis (ABR)

    Angiographic binary restenosis (ABR), defined as target lesion DS ≥ 50% at follow up

    Measured: 9 months

  4. Target lesion failure (TLF)

    Target lesion failure (TLF), including cardiac death, target vessel-myocardial infarction (MI), or ischemic-driven target lesion revascularization (ID-TLR)

    Measured: 30 days,6,9 months,and 1,2 years

  5. Patient-oriented composite endpoint (PoCE)

    Patient-oriented composite endpoint (PoCE), including all-cause death, all MI, or any revascularization.

    Measured: 30 days,6,9 months,and 1,2 years

  6. Definite or probable target lesion thrombosis

    Definite or probable target lesion thrombosis, including Acute stent thrombosis, Early stent thrombosis, Late stent thrombosis, Very late stent thrombosis

    Measured: 30 days,6,9 months,and 1,2 years

Timeline

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

  1. First posted7 Jul 2021
  2. Study start10 Mar 2021
  3. Primary completionJun 2022 (estimated)
  4. Study completionApr 2023 (estimated)

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
Single blind
Who is masked
Outcomes assessor
Enrolment
286 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04953117
Sponsor's protocol ID
LP-SDCB-2020
Status last verified
Jun 2021
First submitted
28 Jun 2021
Last updated
7 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing DCB of Lepu Medical(dimeter≥2.00 mm), Restore DEB and DCB of Lepu Medical(dimeter<2.00 mm) in people with Coronary Artery Disease, run by Lepu Medical Technology (Beijing) Co., Ltd. at 14 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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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?

Results are not available in the source record.

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

Contact Ting Zhang (+86-010-80120666, ting_zhang@lepumedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-segment late lumen loss(LLL) (time frame: 9 months). 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 NCT04953117.

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 7 Jul 2021.

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