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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04953117
• Other study ID #: LP-SDCB-2020
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: April 2023

Study information

• Verified date: June 2021
• Source: Lepu Medical Technology (Beijing) Co., Ltd.
• Contact: Ting Zhang
• Phone: +86-010-80120666
• Email: ting_zhang[@]lepumedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 286
• Est. completion date: April 2023
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• DCB of Lepu Medical(dimeter=2.00 mm)
subjects receiving DCB of Lepu Medical(dimeter=2.00 mm)
• Restore DEB
subjects receiving Restore DEB
• DCB of Lepu Medical(dimeter<2.00 mm)
subjects receiving DCB of Lepu Medical(dimeter<2.00 mm)

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Chao-Yang Hospital, Cpaital Medical University	Beijing	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Peking University Shougang Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The Second Hospital of Jilin University	Chang chun	Jilin
China	Daqing Oilfield General Hospital	Daqing	Heilongjiang
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Sir Run Run Shaw Hospital,School of Medicine	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Inner Mongolia People's Hospital	Hohhot	Neimenggu
China	No.980 Hospital of Joint Logistics Support Force	Shijiazhuang	Hebei
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Lepu Medical Technology (Beijing) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-segment late lumen loss(LLL)	In-segment late lumen loss is defined as the change in minimal lumen diameter	9 months
Secondary	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	2-3 days
Secondary	In-segment diameter stenosis(DS%)	In-segment diameter stenosis(DS%) defined as (1-minimal luminal diameter[MLD]/reference vessel diameter[RVD])*100%.	9 months
Secondary	Angiographic binary restenosis (ABR)	Angiographic binary restenosis (ABR), defined as target lesion DS = 50% at follow up	9 months
Secondary	Target lesion failure (TLF)	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
Secondary	Patient-oriented composite endpoint (PoCE)	Patient-oriented composite endpoint (PoCE), including all-cause death, all MI, or any revascularization.	30 days,6,9 months,and 1,2 years
Secondary	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	30 days,6,9 months,and 1,2 years