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

Lepu Medical Technology

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Device: DCB of Lepu Medical(dimeter<2.00 mm); Device: Restore DEB; Device: DCB of Lepu Medical(dimeter≥2.00 mm)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04953117

LP-SDCB-2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 286 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

286 participants in 3 patient groups

small vessel cohort: DCB of Lepu Medical

Experimental group

Description:

receiving the treatment with DCB of Lepu Medical(dimeter≥2.00 mm) in small vessel cohort

Treatment:

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

small vessel cohort:Restore DEB

Active Comparator group

Description:

receiving the treatment with Restore DEB in small vessel cohort

Treatment:

Device: Restore DEB

very small vessel cohort: DCB of Lepu Medical

Other group

Description:

receiving the treatment with DCB of Lepu Medical(dimeter\<2.00 mm) in very small vessel cohort

Treatment:

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