Coronary Artery Disease
Conditions
Keywords
Bioresorbable Vascular Scaffold System, Percutaneous Coronary Intervention
Brief summary
This study is a prospective, multi-center single arm registry trial, planning to enroll 785 subjects. All subjects will receive clinical follow-up at 1 month, 6 month, 9 month and 1, 2, 3, 4, 5 year after index procedure. The primary endpoint will be target lesion failure (TLF) at 1 year after index procedure,which will be analyzed to evaluate the efficacy and safety of the device.
Interventions
DEVICEThe Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
Subjects enrolled will be treated with Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent.
Sponsors
CCRF Inc., Beijing, China
Shanghai Bio-heart Biological Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: 1. Age from 18 to 75 years old, man or non-pregnant woman. 2. Subjects with asymptomatic ischemic evidence, stable or unstable angina, or old myocardial infarction, are suitable for selective PCI. 3. Subjects without contraindications of coronary artery bypass grafting (CABG). 4. Subjects are able to understand the purpose of this study, volunteer to participate and sign informed consent. Angiographic Inclusion Criteria: 1. One or two de novo target lesions 1. If subject has only one target lesion, the second non-target lesion must be treated but the non-target lesion must be present in a different epicardial vessel; the non target lesion must be treated first and successfully prior to the subjects' register. 2. If there are two target lesions, they must be present in different epicardial vessels. 3. The definition of epicardial vessels means the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) and their branches. Thus, for example, the subject must not have lesions requiring treatment in both the LAD and a branch. 2. Target lesion diameter stenosis is estimated visually ≥ 70% (or ≥ 50% with clinical evidence of myocardial ischemia), with TIMI flow grade ≥1; Target lesion length ≤24mm (visually); target lesion diameter between ≥2.5 mm to ≤ 4.00 mm. 3. Each target lesion must be covered completely by one scaffold.
Exclusion criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TLF | 1 year after index procedure | Target lesion failure, consists of cardiac death, MI attributed to the target vessel, and ischemic driven - target lesion revascularization (ID-TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The patient-oriented composite（PoCE） | at 1, 6, 9 month and 1, 2, 3, 4, 5 year after index procedure | includes all-cause mortality, any MI, and any revascularization. Death（Cardiac death，Vascular death，Non-cardiovascular death）; Myocardial Infarction (target vessel MI, non-target vessel MI); Target lesion Revascularization（ischemic driven, non-ischemic driven） target vessel Revascularization （ischemic driven, non-ischemic driven）; Any Revascularization （ischemic driven, non-ischemic driven）. |
| Stent Thrombosis（ARC） | at 1, 6, 9 month and 1, 2, 3, 4, 5 year after index procedure | Timing：Acute, Subacute, Late,Very late stent thrombosis Definite and Probable Stent Thrombosis |
| The device-oriented composite（DoCE） / TLF | at 1, 6, 9 month and 1, 2, 3, 4, 5 year after index procedure | consists of cardiac death, MI attributed to the target vessel, and ischemic driven- target lesion revascularization (ID-TLR). |
| Lesion success | immediately after index procedure | defined as attainment of diameter residual stenosis less than 30% by visual estimation and TIMI flow grade 3, after the target lesion treated by any PCI methods |
| Clinical success | up to 7 days after index procedure | defined as attainment of lesion success and without any major adverse cardiac events during hospitalization (up to 7 days after index procedure) |
| Device success | immediately after index procedure | defined as attainment of residual stenosis less than 30% by visual estimation and TIMI flow grade 3 post stent implantation |
Countries
China
Contacts
Primary ContactGuosheng Fu, Professor
Outcome results
None listed