Efficacy and Safety of Nano+ Polymer-free Sirolimus-Eluting Stent: A Optical Coherent Tomography Study

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Device: Nano+ DES

• Registration Number: NCT01925027
• Lead Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-08-04
• Study First Submitted QC: 2013-08-15
• Study First Posted: 2013-08-19
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-14
• Last Update Posted: 2015-12-15
• Primary Completion: 2016-07
• Study Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NANO+ DES	Nano+ DES	The Nano+ Polymer-free Sirolimus-Eluting Coronary Stent System is device/drug combination products consisting of a drug-coated stent and a balloon expandable delivery system. The stent is coated with a formulation containing rapamycin, the active ingredient, adhered to 316L stainless bare stent scaffold with submicron micropores, and is approved by State Food and Drug Administration of China in 2011(No. 3460037).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mean/Minimal Lumen diameter/area/volume	3-month
Mean/maximal thickness of the struts coverage	3-month
Percentage of covered struts	3-month
Neointimal hyperplasia area/volume	3-month
Mean/Minimal Stent diameter/area/volume	3-month
Incomplete strut apposition	3-month

Trial Locations

Locations (5)

UZ Virga Jesse Ziekenhuis; 🇧🇪 Hasselt, Belgium

CHU Sart Tillman; 🇧🇪 Liège, Belgium

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

Erasmus Medical Centre; 🇳🇱 Rotterdam, Netherlands