ACOART Paclitaxel SVD:Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases

Acotec Scientific

Status: Enrolling

Conditions: Coronary Disease

Treatments: Device: test DCB; Device: RESTORE DCB

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04626687

ACOART paclitaxel SVD

Details and patient eligibility

About

The purpose of the trial is to determine whether DCB made by Acotec Scientific is not inferior to RESTORE DEB made by CARDIONOVUM GmbH in treatment of small vessel coronary disease.

Full description

This is a prospective, multi-center, randomized-controlled clinical trial to verify the efficacy and safety of DCB made by Acotec Scientific versus RESTORE DEB in treatment of small vessel coronary disease. And the primary endpoint is angiographic restenosis at 9 months post-procedure.

Enrollment: 230 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 80 years of age
• Subjects with symptomatic coronary artery disease with stable and unstable angina pectoris or secondary evaluation of stenosis after acute myocardial infarction (MI) and asymptomatic subjects with coronary atherosclerotic stenosis causing myocardial ischemia determined by the investigator
• Subjects with single, de novo lesion with stenosis of more than 70% (or more than 50% combined with symptoms of ischemia) in a vessel with visually estimated reference vessel diameter (RVD) ≥ 2.00 mm and ≤ 2.75 mm, and ≤ 26 mm in length.
• Subject must agree to clinical follow-up at 1, 6, 9, 12 months, and angiographic follow-up at 9 months.
• Subject can understand the study objectives psychologically and linguistically and shows sufficient compliance to the study protocol. Subjects express acceptance of the risks and benefits described in the informed consent form.

Exclusion criteria

• AMI within 1 week.
• Subject has congestive heart failure or NYHA IV.
• Subject with LVEF < 35%.
• Subject has undergone heart transplantation.
• Subject has cardiac arrhythmias, such as high-risk ventricular premature beat and/or ventricular tachycardia.
• Subject suffered stroke, gastrointestinal bleeding or active ulcer within the past 6 months, or with conditions associated with high risk of bleeding.
• Subject with a history of leukopenia (white blood cell count of < 3×109/L for >3 days), neutropenia (ANC<1000/mm3 for >3 days) or thrombocytopenia (platelet <100,000/mm3).
• Known renal insufficiency (eGFR<30 ml/min).
• Subject who is forbidden to use anticoagulation agents or anti-platelet drugs, and tolerate Aspirin or Clopidogrel.
• Life expectancy less than 12 months, or subjects who cannot complete 12-month follow-up.
• Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
• Subject is currently participating in another investigational drug or device study that has not yet completed its primary endpoint.
• Subject unsuitable for study according to the investigator due to the investigator due to other reasons related to diseases.
• Angiography exclusions:Target lesion: Total occlusion lesion (TIMI 0), heavy calcified lesion that cannot be successfully dilated, bifurcation lesion (side branch ≥ 2.0 mm in diameter), restenosis lesion, thrombotic lesion, or left main disease;Non-target lesion: More than 2 non-target lesions or non-target lesion cannot be successfully treated.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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230 participants in 2 patient groups

test DCB group

Experimental group

Description:

use the DCB made by Acotec Scientific

Treatment:

Device: test DCB

RESTORE DCB group

Active Comparator group

Description:

use the DCB made by CARDIONOVUM GmbH

Treatment:

Device: RESTORE DCB