Clinical trial NCT04626687: ACOART Paclitaxel SVD:Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases
Official title: Paclitaxel Coated Coronary Balloon Catheter in Treatment of Coronary Small Vessel Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Disease
Keywords: coronary small vessel diseases
DCB
Lead sponsor: Acotec Scientific Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Tongji Hospital, Tongji University School of Medicine
First posted: 2020-11-12
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Angiographic percent diameter stenosis
timeFrame: at 9 months post-procedure
Secondary outcomes:
measure: Acute success
timeFrame: in the procedure
measure: Rate of target lesion failure
timeFrame: within 12 months post-procedure
measure: Diameter stenosis in-device
timeFrame: at 9 months post-procedure
measure: Late lumen loss
timeFrame: at 9 months post-procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tongji Hospital, Tongji University School of Medicine
Study officials:
affiliation: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Xuebo Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: