Primary Objective The objective of this study is to evaluate the extent of neointima formation at 3 month after (successful) implantation of the Nano+ stent in a single lesion in elective PCI patients. Secondary Objective To assess if NanoTM Polymer…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is: in-stent neointimal hyperplasia volume obstruction (%)
at 3 months follow-up by OCT assessment.
Secondary outcome
OCT endpoints (as assessed by a central Core Laboratory):
• Neointimal hyperplasia area/volume at 3 months follow-up;
• Mean/Minimal Stent diameter/area/volume at 3 months follow-up;
• Mean/Minimal Lumen diameter/area/volume at 3 months follow-up;
• Mean/maximal thickness of the struts coverage at 3 month
• Percentage number of covered struts at 3 months
• Incomplete strut apposition at 3 months
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.
Angiographic endpoints:
• MLD and %DS post procedure and at 3 months
• Late Lumen Loss at 3 months;
• Binary Restenosis (DS >=50%) at 3 months
• All measurements will be made of the in-stent, in-segment, proximal and
distal stent margins.
Clinical endpoints:
• Acute success (device and procedural success);
• Device-oriented Composite Endpoints at 3, 4 and 5 months and annually to 2
years and its individual components. (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)
• Stent thrombosis according to the ARC definitions at 3, 4 and 5 months and
annually to 2 years
• Other Adverse Device Effects
Background summary
Measure the extent of neointima formation at 3 month after (successful)
implantation of the NanoTM Polymer-free Sirolimus Coronary Stent System in a
single lesion in elective PCI patients to assess if an improved early arterial
healing and therefore reduce the late stent thrombosis risk is achieved then
drug eluting stents already on the market. Consequently, clopidogrel treatment
can be discontinued at 3 months after PCI instead of the standard prescribed 12
months.
Study objective
Primary Objective
The objective of this study is to evaluate the extent of neointima formation at
3 month after (successful) implantation of the Nano+ stent in a single lesion
in elective PCI patients.
Secondary Objective
To assess if NanoTM Polymer-free Sirolimus Coronary Stent System has an
improved early arterial healing and therefore reduce the late stent thrombosis
risk. Consequently, clopidogrel treatment can be discontinued at 3 months after
PCI.
Study design
This is a prospective, multicentre, single arm, open-label study, which will
enrol (competitive enrolment) a total of 45 patients in approximately 4-5
European investigational sites.
All patients will be treated with the NanoTM Polymer-free Sirolimus Coronary
Stent System.
Intervention
All patients will be treated with the NanoTM Polymer-free Sirolimus Coronary
Stent System.
Study burden and risks
There is only a low dose of medication on the stent, which could give a risk on
side effects. Treatment could have additional risks, but these are still
unknown. The expected adverse events for implatnation of the study stent are
equal to the stents that already have CE mark.
When treatment with Clopidogrel is stopped before the standard period of 12
months, there is an elevated chance on stent thrombosis. During the study the
patient will be followed to register and report all events, monitoring is
performed and a CEC and DSMB monitor the study to guard the safety of the
patients.
ChaoQian Road No.37
Changping Tech. Zone, Beijing 102200
CN
ChaoQian Road No.37
Changping Tech. Zone, Beijing 102200
CN
Listed location countries
Age
Inclusion criteria
1) 18 to 85 years;
2) Evidence of myocardial ischemia without raised troponin (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study);
3) The patient has a planned intervention of up to two de novo lesions, in different epicardial vessels;
4) Lesion(s) must have a visually estimated diameter stenosis of >=50% and <100%;
5) Lesion length must be <18mm;
6) RVD must be between 2.5-4.0 mm;
7) Written informed consent;
8) The patient and the patient*s physician agree to the follow-up visits including angiographic follow-up and OCT controls at 3 months.
Exclusion criteria
1) Evidence of ongoing acute myocardial infarction in ECG prior to procedure;
2) LVEF <30%;
3) 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);
4) Known renal insufficiency (e.g., eGFR <60 ml/kg/m2 or serum creatinine level of >2.5 mg/dL, or subject on dialysis);
5) History of bleeding diathesis or coagulopathy;
6) The patient is a recipient of a heart transplant;
7) 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;
8) 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;
9) Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42460.078.13 |