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

NCT04953117 | Unknown

• 1 other identifier: LP-SDCB-2020
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 14

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

Drug Coated Balloon Catheter; Small Coronary Vessel Disease; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• In-segment late lumen loss(LLL)

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

  9 months

Secondary Outcomes (6)

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

  2-3 days

• In-segment diameter stenosis(DS%)

  9 months

• Angiographic binary restenosis (ABR)

  9 months

• Target lesion failure (TLF)

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

• Patient-oriented composite endpoint (PoCE)

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

Study Arms (3)

small vessel cohort: DCB of Lepu Medical

EXPERIMENTAL

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)

small vessel cohort:Restore DEB

ACTIVE COMPARATOR

receiving the treatment with Restore DEB in small vessel cohort

Device: Restore DEB

very small vessel cohort: DCB of Lepu Medical

OTHER

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)

Interventions

DCB of Lepu Medical(dimeter<2.00 mm) DEVICE

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

Also known as: Coronary Drug Coated Balloon Catheter of Lepu Medical for coronary very small vessels

very small vessel cohort: DCB of Lepu Medical

Restore DEB DEVICE

subjects receiving Restore DEB

Also known as: RESTORE Paclitaxel releasing coronary balloon catheter

small vessel cohort:Restore DEB

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lepu Medical Technology (Beijing) Co., Ltd.: lead

Study Sites (14)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Beijing Chao-Yang Hospital, Cpaital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Peking University Shougang Hospital

Beijing, Beijing Municipality, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 50031, China

RECRUITING

No.980 Hospital of Joint Logistics Support Force

Shijiazhuang, Hebei, 50082, China

RECRUITING

Daqing Oilfield General Hospital

Daqing, Heilongjiang, 163411, China

RECRUITING

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

RECRUITING

Inner Mongolia People's Hospital

Hohhot, Neimenggu, 010017, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

Sir Run Run Shaw Hospital,School of Medicine

Hangzhou, Zhejiang, 310016, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310058, China

RECRUITING

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

• Yida Tang

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Ting Zhang

CONTACT

+86-010-80120666; ting_zhang@lepumedical.com

Study Design

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

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 7, 2021
• Study Start: March 10, 2021
• Primary Completion: June 1, 2022
• Study Completion: April 1, 2023
• Last Updated: July 7, 2021

Record last verified: 2021-06

Locations

CN (14)