Coronary Disease
Conditions
Keywords
coronary small vessel diseases, DCB
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.
Interventions
DEVICEtest DCB
use paclitaxel coated coronary balloon catheters to treat SVD
DEVICERESTORE DCB
use paclitaxel coated coronary balloon catheters(RESTORE DCB) with NMPA approval indication for treating SVD
Sponsors
Shanghai Tongji Hospital, Tongji University School of Medicine
Acotec Scientific Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic percent diameter stenosis | at 9 months post-procedure | (1-Segmental minimum lumen diameter \[MLD\]/ segmental reference vessel diameter \[RVD\]) ×100% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute success | in the procedure | Including instrument success rate, lesion success rate and surgical success rate |
| Rate of target lesion failure | within 12 months post-procedure | A composite of cardiac death, target-vessel related myocardial infarction, and ischemia-driven target lesion revascularization |
| Diameter stenosis in-device | at 9 months post-procedure | (1-the minimum cavity diameter of the device \[MLD\] / the reference vessel diameter of the device \[RVD\]) ×100% |
| Late lumen loss | at 9 months post-procedure | Loss of late lumen in the segment and device |
Countries
China
Contacts
Primary ContactXuebo Liu, MD
Outcome results
None listed