Coronary Artery DiseasePhase 4NCT01925027
Efficacy and Safety of Nano+ Polymer-free Sirolimus-Eluting Stent: A Optical Coherent Tomography Study
A Phase 4 study testing Nano+ DES in people with Coronary Artery Disease, run by Lepu Medical Technology (Beijing) Co., Ltd. at 5 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Nano+ DES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jul 2013to Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
5 sites in 2 countries.
Ziye Sui contact
5 sites in 2 countries
Netherlands3 sites, 3 recruiting
- Recruiting
Medisch Spectrum Twente
Enschede, 7511
C von Birgelen, Dr, 0031 53 487 21 05, C.vonBirgelen@mst.nl
C von Birgelen, Dr
- Recruiting
Medisch Centrum Leeuwarden
Leeuwarden, 8934
S Hofma, Dr, 0031 58 286 66 66, S.H.Hofma@ZNB.NL
S Hofma, Dr
- Recruiting
Erasmus Medical Centre
Rotterdam, 3015
R.J.M van Geuns, Dr, 0031 10 703 33 48, r.vangeuns@erasmusmc.nl
R.J.M van Geuns, Dr
Belgium2 sites, 2 recruiting
- Recruiting
UZ Virga Jesse Ziekenhuis
Hasselt, B-3500
E Benit, Dr, 0032 11 309 440, edouard.benit@virgajesse.be
E Benit, Dr
- Recruiting
CHU Sart Tillman
Liège, B-4000
V Legrand, Prof, 0032 4 366 71 92, vlegrand@chu.ulg.ac.be
V Legrand, Prof
About this 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
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Nano+ DES
- Keywords
- Nano+ DES, OCT, Neointimal hyperplasia, DAPT, 3 month
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano+ DESDevice
Also called NANO+ Polymer-free Sirolimus-Eluting Stent
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Nano+ DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-month
Secondary outcomes (6)
Neointimal hyperplasia area/volume
Measured: 3-month
Mean/Minimal Stent diameter/area/volume
Measured: 3-month
Mean/Minimal Lumen diameter/area/volume
Measured: 3-month
Mean/maximal thickness of the struts coverage
Measured: 3-month
Percentage of covered struts
Measured: 3-month
Incomplete strut apposition
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick W Serruys, PhD, Study chair, Erasmus Medical CenterRun-Lin Gao, MD, Principal investigator, Fu Wai Hospital, Beijing, ChinaBo Xu, MSc, Principal investigator, Fu Wai Hospital, Beijing, ChinaYao-Jun Zhang, PhD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925027
- Sponsor's protocol ID
- 120025
- Status last verified
- Dec 2015
- First submitted
- 4 Aug 2013
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01925027
- Acronym / sponsor ID
- 120025
- Conditions
- Coronary Artery Disease
- Keywords
- Nano+ DES, OCT, Neointimal hyperplasia, DAPT, 3 month
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 19 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NANO+ DES | Experimental | Device: Nano+ DESThe 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nano+ DESAlso: NANO+ Polymer-free Sirolimus-Eluting StentAll 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. | Device | NANO+ DES |
Primary outcome
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.
6 secondary outcomes
Neointimal hyperplasia area/volume
Time frame: 3-month
Mean/Minimal Stent diameter/area/volume
Time frame: 3-month
Mean/Minimal Lumen diameter/area/volume
Time frame: 3-month
Mean/maximal thickness of the struts coverage
Time frame: 3-month
Percentage of covered struts
Time frame: 3-month
Incomplete strut apposition
Time frame: 3-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziye Sui contact
Patrick W Serruys, PhD study chair
Erasmus Medical Center
Run-Lin Gao, MD principal investigator
Fu Wai Hospital, Beijing, China
Bo Xu, MSc principal investigator
Fu Wai Hospital, Beijing, China
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nano+ DES in people with Coronary Artery Disease, run by Lepu Medical Technology (Beijing) Co., Ltd. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ziye Sui (008613699225528), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent neointimal hyperplasia volume obstruction (%) (time frame: 3-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015.