Antineoplastic Agents, Coronary Artery Disease
Conditions
Keywords
Bioresorbable Vascular Scaffold System, Percutaneous Coronary Intervention, Cardiac Catheterization, Tomography, Optical Coherence
Brief summary
The Bioheart Randomized Controlled Trial is a prospective multicentred paralleled study, which will enroll 430 patients and randomized 1:1 to study group and control group. Aim to assess the efficacy and safety of Rapamycin Drug-Eluting Bioresorbable Coronary Stent System compare with XIENCE stent in the treatment of patients with up to two coronary lesions.
Detailed description
This study is a prospective, multicentred randomized controlled trial, planning to enroll 430 subjects and randomize 1:1 to study group and control group. All subjects will accept clinical evaluation at 1 month, 6 month, 9 month and 1, 2, 3, 4, 5 year post procedure. All subjects will accept angiographic evaluation at 1 year post procedure, and simutaneously 80 subjects (40 in study group and 40 in control group) will accepted OCT evaluation. To assess the efficacy and safety, the primary endpoint will be in segment late luminal loss at 1 year post procedure, the secondary endpoint is neointima coverage percentage of stent strut (%) at 1 year post procedure.
Interventions
DEVICEstudy group
study group in which patient will accept the treatment of Bioresorbable Coronary Stent
DEVICEcontrol group
control group in which patient will accept the treatment of Drug Eluting Stent of Abbott's XIENCE PRIME™ or XIENCE V®
Sponsors
CCRF Inc., Beijing, China
Shanghai Bio-heart Biological Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
subjects that participate in this study must fulfill all the following 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, 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, willing to accept invasive imaging follow-up. Angiographic inclusion criteria: 1. One or two de novo target lesions 1. If subject has only one target lesion, the second non-target lesion can be treated but this non-target lesion must locate in a different epicardial vessel, and must be treated first and be treated successfully prior to the subjects' randomization. 2. If there are two target lesions, they must locate in different epicardial vessels and both satisfy the angiographic eligibility criteria. 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 diagonal branch 2. Target lesion diameter stenosis ≥ 70% (or ≥ 50% simultaneously shall have clinical evidence of myocardial ischemia), and TIMI flow grade ≥1; Target lesion length ≤24mm (visually); target lesion diameter between ≥ 2.5 mm to ≤ 4.00 mm. 3. Each target lesion can be fully covered by one stent.
Exclusion criteria
If subjects fulfill any of below criterias, this subject shall be exclude from this study. general
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| in segment late luminal loss | 1 year post procedure | In-segment late loss is defined as the change in minimal lumen diameter (MLD) from post-procedure to 1 year by angiography，in segment is defined within the margins of the scaffold/stent and 5 mm proximal and 5 mm distal to the scaffold/stent. |
| neointima coverage percentage of stent strut (%) | 1 year post procedure | only in OCT subgroup |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lesion success | immediately post 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 |
| Device oriented composite endpoint (DoCE)/target lesion failure (TLF) | at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure | defined as Cardiac Death, target vessel - myocardial infarction (TV-MI), and ischemic driven - target lesion revascularization (ID-TLR) |
| Patient oriented composite endpoint (PoCE) | at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure | defined as all caused death, any myocardial infarction, and any revascularization. |
| death | at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure | cardiac death, vascular death, non-cardiovascular death |
| myocardial infarction (MI) | at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure | target vessel MI, non-target vessel MI |
| target lesion revascularization | at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure | ischemic driven, non-ischemic driven |
| target vessel revascularization | at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure | ischemic driven, non-ischemic driven |
| any coronary revascularization | at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure | — |
| ARC--defined stent thrombosis | at 1, 6, 9 month and1, 2, 3, 4, 5 year post procedure | timing (acute, subacute, late and very late stent thrombosis); relationship (definite, probable and possible stent thrombosis) |
| clinical success | at 1 month post procedure | defined as attainment of lesion success and without any major adverse cardiac events during hospitalization (up to 7 days after proceduce) |
| device success | immediately post procedure | defined as attainment of residual stenosis less than 30% by visual estimation and TIMI flow grade 3 post stent implantation |
Other
| Measure | Time frame | Description |
|---|---|---|
| angiographic endpoints-acute stent recoil | immediately post procedure | assess in milimeter |
| angiographic endpoints-late lumen loss (LLL) | immediately and 1 year post procedure | include in stent, 5mm proximal and distal to the stent； |
| angiographic endpoints-minimal lumen diameter (MLD) | immediately and 1 year post procedure | include in stent, 5mm proximal and distal to the stent and in segment； |
| angiographic endpoints-diameter stenosis (DS), | immediately and 1 year post procedure | assess in percentage, include in stent, 5mm proximal and distal to the stent and in segment； |
| angiographic endpoints-angiographic binary restenosis (ABR), | 1 year post procedure | assess in percentage, include in stent, 5mm proximal and distal to the stent and in segment. |
| OCT imaging endpoints-Neointimal tissue thickness | 1 year post procedure | assess in millimeter |
| OCT imaging endpoints-late acquired stent malapposition | 1 year post procedure | assess in millimeter |
| OCT imaging endpoints-Volume obstruction percentage | 1 year post procedure | assess in percentage |
| OCT imaging endpoints-Late stent recoil | 1 year post procedure | assess both in percentage and square millimeter |
| OCT imaging endpoints-Neointimal Healing Score | 1 year post procedure | will be calculated by OCT imaging software |
Countries
China
Outcome results
None listed