- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01925027
Efficacy and Safety of Nano+ Polymer-free Sirolimus-Eluting Stent: A Optical Coherent Tomography Study
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 Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Ziye Sui
- Phone Number: 008613699225528
Study Contact Backup
- Name: Wei Cui
- Phone Number: 008613910984630
- Email: wei8723@hotmail.com
Study Locations
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-
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Hasselt, Belgium, B-3500
- Recruiting
- UZ Virga Jesse Ziekenhuis
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Contact:
- E Benit, Dr
- Phone Number: 0032 11 309 440
- Email: edouard.benit@virgajesse.be
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Principal Investigator:
- E Benit, Dr
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Liège, Belgium, B-4000
- Recruiting
- CHU Sart Tillman
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Contact:
- V Legrand, Prof
- Phone Number: 0032 4 366 71 92
- Email: vlegrand@chu.ulg.ac.be
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Principal Investigator:
- V Legrand, Prof
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-
-
-
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Enschede, Netherlands, 7511
- Recruiting
- Medisch Spectrum Twente
-
Contact:
- C von Birgelen, Dr
- Phone Number: 0031 53 487 21 05
- Email: C.vonBirgelen@mst.nl
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Principal Investigator:
- C von Birgelen, Dr
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Leeuwarden, Netherlands, 8934
- Recruiting
- Medisch Centrum Leeuwarden
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Contact:
- S Hofma, Dr
- Phone Number: 0031 58 286 66 66
- Email: S.H.Hofma@ZNB.NL
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Principal Investigator:
- S Hofma, Dr
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Rotterdam, Netherlands, 3015
- Recruiting
- Erasmus Medical Centre
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Contact:
- R.J.M van Geuns, Dr
- Phone Number: 0031 10 703 33 48
- Email: r.vangeuns@erasmusmc.nl
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Principal Investigator:
- R.J.M van Geuns, Dr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In-stent neointimal hyperplasia volume obstruction (%)
Time Frame: 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.
|
3-month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Neointimal hyperplasia area/volume
Time Frame: 3-month
|
3-month
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Mean/Minimal Stent diameter/area/volume
Time Frame: 3-month
|
3-month
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Mean/Minimal Lumen diameter/area/volume
Time Frame: 3-month
|
3-month
|
Mean/maximal thickness of the struts coverage
Time Frame: 3-month
|
3-month
|
Percentage of covered struts
Time Frame: 3-month
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3-month
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Incomplete strut apposition
Time Frame: 3-month
|
3-month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MLD and %DS
Time Frame: 3-month
|
All measurements will be made of the in-stent, in-segment, proximal and distal stent margins.
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3-month
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Late Lumen Loss
Time Frame: 3-month
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The difference between the minimum lumen diameter (MLD) post procedure and the MLD at 3 month follow-up.
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3-month
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Binary Restenosis (DS ≥50%)
Time Frame: 3-month
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3-month
|
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Acute success
Time Frame: 3 month
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Acute success will be classified according to the following definitions:
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3 month
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Device-oriented Composite Endpoints and its individual component
Time Frame: up to 2 years
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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
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up to 2 years
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Stent thrombosis
Time Frame: up to 2 years
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According to the ARC definitions
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up to 2 years
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Collaborators and Investigators
Investigators
- Study Chair: Patrick W Serruys, PhD, Erasmus Medical Center
- Principal Investigator: 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- 120025
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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