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

NCT01925027 | Unknown Phase 4 DMC

• 1 other identifier: 120025
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 5

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.

Conditions

Coronary Artery Disease

Keywords

Nano+ DES; OCT; Neointimal hyperplasia; DAPT; 3 month

Outcome Measures

Primary Outcomes (1)

• In-stent neointimal hyperplasia volume obstruction (%)

  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.

  3-month

Secondary Outcomes (6)

• 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

Other Outcomes (6)

• MLD and %DS

  3-month

• Late Lumen Loss

  3-month

• Binary Restenosis (DS ≥50%)

  3-month

Study Arms (1)

NANO+ DES

EXPERIMENTAL

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).

Device: Nano+ DES

Interventions

Nano+ DES DEVICE

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.

Also known as: NANO+ Polymer-free Sirolimus-Eluting Stent

NANO+ DES

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lepu Medical Technology (Beijing) Co., Ltd.: lead

Study Sites (5)

UZ Virga Jesse Ziekenhuis

Hasselt, B-3500, Belgium

RECRUITING

CHU Sart Tillman

Liège, B-4000, Belgium

RECRUITING

Medisch Spectrum Twente

Enschede, 7511, Netherlands

RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, 8934, Netherlands

RECRUITING

Erasmus Medical Centre

Rotterdam, 3015, Netherlands

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Patrick W Serruys, PhD

  Erasmus Medical Center

  STUDY CHAIR

• Run-Lin Gao, MD

  Fu Wai Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

• Bo Xu, MSc

  Fu Wai Hospital, Beijing, China

  PRINCIPAL INVESTIGATOR

• Yao-Jun Zhang, PhD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziye Sui

CONTACT

008613699225528

Wei Cui

CONTACT

008613910984630; wei8723@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2013
• First Posted: August 19, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

NL (3); BE (2)