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

June 28, 2021 updated by: Lepu Medical Technology (Beijing) Co., Ltd.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

286

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
        • Contact:
          • Hui Chen
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Beijing Anzhen Hospital, Capital Medical University
        • Contact:
          • Yong Zeng
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Yida Tang
        • Contact:
          • Guisong Wang
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Chao-Yang Hospital, Cpaital Medical University
        • Contact:
          • Lefeng Wang
      • Beijing, Beijing, China
        • Recruiting
        • Peking University Shougang Hospital
        • Contact:
          • Qiang Tang
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
          • lianglong chen
    • Hebei
      • Shijiazhuang, Hebei, China, 50031
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
          • Gang Liu
      • Shijiazhuang, Hebei, China, 50082
        • Recruiting
        • No.980 Hospital of Joint Logistics Support Force
        • Contact:
          • Leisheng Ru
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163411
        • Recruiting
        • Daqing Oilfield General Hospital
        • Contact:
          • Hui Li
    • Jilin
      • Chang chun, Jilin, China, 130041
        • Recruiting
        • The Second Hospital of Jilin University
        • Contact:
          • Bin Liu
    • Neimenggu
      • Hohhot, Neimenggu, China, 010017
        • Recruiting
        • Inner Mongolia People's Hospital
        • Contact:
          • Xi Liu
    • Tianjin
      • Tianjin, Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
          • Qing Yang
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital,School of Medicine
        • Contact:
          • guosheng Fu
      • Hangzhou, Zhejiang, China, 310058
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
          • Jun Jiang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: small vessel cohort: DCB of Lepu Medical
receiving the treatment with DCB of Lepu Medical(dimeter≥2.00 mm) in small vessel cohort
Device: DCB of Lepu Medical(dimeter≥2.00 mm)
subjects receiving DCB of Lepu Medical(dimeter≥2.00 mm)
Other Names:
  • Coronary Drug Coated Balloon Catheter of Lepu Medical for coronary small vessels
Active Comparator: small vessel cohort:Restore DEB
receiving the treatment with Restore DEB in small vessel cohort
Device: Restore DEB
subjects receiving Restore DEB
Other Names:
  • RESTORE Paclitaxel releasing coronary balloon catheter
Other: very small vessel cohort: DCB of Lepu Medical
receiving the treatment with DCB of Lepu Medical(dimeter<2.00 mm) in very small vessel cohort
Device: DCB of Lepu Medical(dimeter<2.00 mm)
subjects receiving DCB of Lepu Medical(dimeter<2.00 mm)
Other Names:
  • Coronary Drug Coated Balloon Catheter of Lepu Medical for coronary very small vessels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-segment late lumen loss(LLL)
Time Frame: 9 months
In-segment late lumen loss is defined as the change in minimal lumen diameter
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The success rate of intervention treatment (%)(Device success,Lesion success ,Procedural success)
Time Frame: 2-3 days
The success rate of intervention treatment (%) include device success,lesion success and procedural success
2-3 days
In-segment diameter stenosis(DS%)
Time Frame: 9 months
In-segment diameter stenosis(DS%) defined as (1-minimal luminal diameter[MLD]/reference vessel diameter[RVD])*100%.
9 months
Angiographic binary restenosis (ABR)
Time Frame: 9 months
Angiographic binary restenosis (ABR), defined as target lesion DS ≥ 50% at follow up
9 months
Target lesion failure (TLF)
Time Frame: 30 days,6,9 months,and 1,2 years
Target lesion failure (TLF), including cardiac death, target vessel-myocardial infarction (MI), or ischemic-driven target lesion revascularization (ID-TLR)
30 days,6,9 months,and 1,2 years
Patient-oriented composite endpoint (PoCE)
Time Frame: 30 days,6,9 months,and 1,2 years
Patient-oriented composite endpoint (PoCE), including all-cause death, all MI, or any revascularization.
30 days,6,9 months,and 1,2 years
Definite or probable target lesion thrombosis
Time Frame: 30 days,6,9 months,and 1,2 years
Definite or probable target lesion thrombosis, including Acute stent thrombosis, Early stent thrombosis, Late stent thrombosis, Very late stent thrombosis
30 days,6,9 months,and 1,2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lepu Medical Technology (Beijing) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

June 28, 2021

First Submitted That Met QC Criteria

June 28, 2021

First Posted (Actual)

July 7, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

June 28, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP-SDCB-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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