Clinical trial NCT01925027: Efficacy and Safety of Nano+ Polymer-free Sirolimus-Eluting Stent: A Optical Coherent Tomography Study
Official title: Efficacy and Safety of Nano+ Polymer-free Sirolimus-Eluting Stent in the Treatment of Patients With De Novo Lesion: A Optical Coherent Tomography Prospective, Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Nano+ DES
OCT
Neointimal hyperplasia
DAPT
3 month
Lead sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: In-stent neointimal hyperplasia volume obstruction (%)
timeFrame: 3-month
Secondary outcomes:
measure: Neointimal hyperplasia area/volume
timeFrame: 3-month
measure: Mean/Minimal Stent diameter/area/volume
timeFrame: 3-month
measure: Mean/Minimal Lumen diameter/area/volume
timeFrame: 3-month
measure: Mean/maximal thickness of the struts coverage
timeFrame: 3-month
measure: Percentage of covered struts
timeFrame: 3-month
measure: Incomplete strut apposition
timeFrame: 3-month
Other outcomes:
measure: MLD and %DS
timeFrame: 3-month
measure: Late Lumen Loss
timeFrame: 3-month
measure: Binary Restenosis (DS ≥50%)
timeFrame: 3-month
measure: Acute success
timeFrame: 3 month
measure: Device-oriented Composite Endpoints and its individual component
timeFrame: up to 2 years
measure: Stent thrombosis
timeFrame: up to 2 years
Locations:
city: Hasselt
country: Belgium
facility: UZ Virga Jesse Ziekenhuis
city: Liège
country: Belgium
facility: CHU Sart Tillman
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Centre
Study officials:
affiliation: Erasmus Medical Center
name: Patrick W Serruys, PhD
role: STUDY_CHAIR
affiliation: Fu Wai Hospital, Beijing, China
name: Run-Lin Gao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fu Wai Hospital, Beijing, China
name: Bo Xu, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Yao-Jun Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: