Coronary Artery Disease
Conditions
Keywords
Nano+ DES, OCT, Neointimal hyperplasia, DAPT, 3 month
Brief summary
Our hypothesis is to test that 1) The safety and efficacy of Nano+ DES in patients with de novo lesions; 2) A low neointimal hyperplasia after Nano+ DES implantation due to its effective and sufficient antiproliferative drug; 3) A very high coverage and an improved early arterial healing after Nano+ DES implantation due to polymer-free; 4) The safety of clopidogrel treatment discontinuation at 3 months when OCT results are defined as optimal.
Detailed description
Eligibility criteria: * 18 to 85 years. * Evidence of myocardial ischemia without raised troponin (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study). * The patient has a planned intervention of up to two de novo lesions in different epicardial vessels * Lesion(s) must have a visually estimated diameter stenosis of ≥50% and \<100%. * Lesion length must be \<18mm * RVD must be between 2.5-4.0 mm * Written informed consent. * The patient and the patient's physician agree to the follow-up visits including angiographic follow-up and OCT assessment at 3 months. Design details and outcomes This is a prospective, multicentre, single arm, open- label study, which will enroll a total of 45 patients in 5 European investigational sites. All patients will be treated with the Nano+ Polymer-free Sirolimus Coronary Stent System. All patients will undergo angiographic (QCA) investigation at baseline (pre- and post-procedure) and at 3 months follow-up. All patients will undergo OCT investigation at 3 months follow-up. OCT investigation will be performed at 6 months follow-up in those patients where the OCT criteria (coverage and stent apposition) were not met at 3 months OCT. Off-line OCT and angiographic data analysis will be undertaken by an independent core laboratory (Cardialysis BV, Rotterdam, The Netherlands) blinded to clinical and procedural characteristics of the patients and according to pre-set Standard Operating Procedures. All patients will be evaluated clinically at 3, 4, 5 months (for patients with 6 months OCT follow-up evaluation will be at 8 months) and at 1 and 2 years. Clinical data will be adjudicated by an independent Clinical Event Committee. An independent Data Safety and Monitoring Board (DSMB) will monitor the individual and collective safety of the patients in the study on an ongoing basis. This is a hypothesis generating study, because no evidence about the expected magnitude of the effect is available at present. Data generated from this study will be compared (historical control) against historical figures of other drug eluting stents available at Cardialysis, for published data.
Interventions
DEVICENano+ DES
All patients will be treated with the NanoTM Polymer-free Sirolimus Coronary Stent System. All patients will undergo angiographic (QCA) investigation at baseline (pre- and post-procedure) and at 3 months follow-up. All patients will undergo OCT investigation at 3 months follow-up. All patients will be evaluated clinically at 3, 4, 5 months (for patients with 6 months OCT follow-up evaluation will be at 8 months) and at 1 and 2 years.
Sponsors
Lepu Medical Technology (Beijing) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 85 years. * Evidence of myocardial ischemia without raised troponin (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study). * The patient has a planned intervention of up to two de novo lesions in different epicardial vessels * Lesion(s) must have a visually estimated diameter stenosis of ≥50% and \<100%. * Lesion length must be \<18mm * RVD must be between 2.5-4.0 mm * Written informed consent. * The patient and the patient's physician agree to the follow-up visits including angiographic follow-up and OCT assessment at 3 months.
Exclusion criteria
* Evidence of ongoing acute myocardial infarction in ECG prior to procedure. * LVEF \<30%. * Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3, a WBC of \<3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis). * Known renal insufficiency (e.g., eGFR \<60 ml/kg/m2 or serum creatinine level of \>2.5 mg/dL, or subject on dialysis). * History of bleeding diathesis or coagulopathy. * The patient is a recipient of a heart transplant. * Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel prasugrel, ticagrelor and ticlopidine), sirolimus or stainless steel. * Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy * Participating in other drugs or medical devices clinical trials, prior to reaching the primary endpoint. * Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-stent neointimal hyperplasia volume obstruction (%) | 3-month | For those patients that did not achieve the optimal/ successful OCT criteria at 3 months an additional OCT investigation will be planned at 6 months follow-up where these same endpoints will be assessed. |
Secondary
| Measure | Time frame |
|---|---|
| Neointimal hyperplasia area/volume | 3-month |
| Mean/Minimal Stent diameter/area/volume | 3-month |
| Mean/Minimal Lumen diameter/area/volume | 3-month |
| Mean/maximal thickness of the struts coverage | 3-month |
| Percentage of covered struts | 3-month |
| Incomplete strut apposition | 3-month |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stent thrombosis | up to 2 years | According to the ARC definitions |
| MLD and %DS | 3-month | All measurements will be made of the in-stent, in-segment, proximal and distal stent margins. |
| Late Lumen Loss | 3-month | The difference between the minimum lumen diameter (MLD) post procedure and the MLD at 3 month follow-up. |
| Binary Restenosis (DS ≥50%) | 3-month | — |
| Acute success | 3 month | Acute success will be classified according to the following definitions: 1. Device success: \< 30% residual stenosis (by on-line QCA) 2. Procedure success: The attainment of \< 30% residual stenosis by QCA AND either a TIMI flow 3 or a consistent TIMI flow 2 before and after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the investigator's assessment as recorded in the CRF will be used for the statistical analysis. |
| Device-oriented Composite Endpoints and its individual component | up to 2 years | Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization |
Countries
Belgium, Netherlands
Contacts
Primary ContactZiye Sui
Backup ContactWei Cui
Outcome results
None listed