The objective of this prospective, observational study is to ensure the safety and the wellbeing of subjects treated with the NEVO* SES.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Twelve month composite clinical endpoint of all death, all MI and all
revascularizations.
Secondary outcome
Measured as defined in the protocol:
- Composite endpoint of all death, all MI and all revascularizations and its
individual components.
- Stent thrombosis defined as definite, probable, possible and composite of
definite and probable at early, late and very late time points (using ARC
definition)
- Bleeding complication
- Stroke
- Device, Procedural and Lesion Success
Background summary
Restenosis remains a frequent cause of late failure after initially successful
coronary angioplasty occurring in as many as 20-40% of procedures performed.
Loss of luminal diameter as a result of restenosis has been attributed to three
physiologic mechanisms: passive elastic recoil of the vessel, geometric vessel
remodelling and neointimal hyperplasia. Coronary stents provide mechanical
scaffolding that reduces restenosis by limiting the extent of elastic recoil
and late vascular remodeling. Despite these improvements, the incidence of
restenosis following coronary stent implantation occurs in 20-40% of cases.
Restenosis following stenting is primarily a result of neointimal hyperplasia.
The methodology in interventional cardiology has historically evolved from
diagnostic coronary angiography to balloon angioplasty, the use of bare metal
stents, their refinement to drug-eluting stents with a durable polymer, and is
now on the verge to drug-eluting stents with further developed drug delivery
approaches such as the reservoir technology and the use of bioresorbable
polymers. While the reservoir approach may make drug delivery more
controllable, the reduction of polymer exposure to the vessel wall was designed
to improve vascular healing and reduce the occurrence of undesirable side
effects such as stent thrombosis especially on the long-term once the drug is
completely eluted.
While to date, these are concepts validated in pre-clinical studies and one
clinical study (name changed from RES-ELUTION to NEVO RES I study), and only
limited clinical data are available to suggest efficacy and safety of the NEVO*
Sirolimus-eluting stents, this study did seek to assess its clinical value in a
large and unselected cohort of subjects representing real-world contemporary
treatment patterns through a non-inferiority comparison with the most widely
used DES today, the XIENCE V® / XIENCE PRIME* / PROMUS® stent.
As a result of evolving market dynamics, and product portfolio decisions,
Cordis decided in June 2011 to no longer pursue the development of NEVO*
Sirolimus-eluting coronary stents. As a result of this decision, the design
and objective of the NEVO II trial were changed to allow only follow-up of the
103 NEVO* subjects.
Since the NEVO* SES is an investigational device, the NEVO* subjects are being
followed-up to safeguard their safety and wellbeing. The 53 subjects from the
comparator arm do not need further follow-up due to the fact that they have
been treated with a commercially available stent.
Study objective
The objective of this prospective, observational study is to ensure the safety
and the wellbeing of subjects treated with the NEVO* SES.
Study design
Prospective, multi-center, open label, observational study, collecting data
from subjects treated with the NEVO* SES
All NEVO* subjects will undergo the following visits:
Clinical follow-up at 30 days, 6 months, 12 months and at 3 and 5 years.
These follow-up contacts will be done by phone call, hospital visit, or by
contacts with primary physicians or referring cardiologists, according to each
investigator*s preference.
Intervention
Percutaneous coronary intervention.
Study burden and risks
Risks associated with using the NEVO* Sirolimus-eluting stent are believed to
be the same as those associated with percutaneous treatment procedures for a
stenosed coronary artery using already approved drug-eluting or bare metal
stents.
Adverse events that may be associated with the implantation of a coronary stent
in coronary arteries include, but are not limited to, the following:
• Cardiac events: myocardial infarction or ischemia, abrupt closure of coronary
artery, restenosis of treated artery, cardiogenic shock, angina, tamponade,
perforation or dissection of coronary artery or aorta, cardiac perforation,
emergency cardiac surgery, pericardial effusion, aneurysm formation.
• Arrhythmic events: ventricular tachycardia, ventricular fibrillation, atrial
fibrillation, bradycardia.
• Stent events: failure to deliver to intended site, stent thrombosis or
occlusion, stent migration, stent embolization, inadequate apposition or
compression of stent/s, rupture of the delivery catheter balloon.
• Respiratory events: acute pulmonary edema, congestive heart failure,
respiratory insufficiency or failure.
• Vascular events: access site hematoma, hypotension/hypertension,
pseudoaneurysm, arteriovenous fistula formation, retroperitoneal hematoma,
vessel dissection or perforation, thrombosis or occlusion, vasospasm,
peripheral ischemia, dissection, distal embolization (air, tissue debris,
thrombus).
• Neurologic events: permanent (stroke) or reversible (TIA) neurologic event,
femoral nerve injury, peripheral nerve injury.
• Bleeding events: access site bleeding or hemorrhage, hemorrhage requiring
transfusion or other treatment.
• Allergic reactions to contrast media, antiplatelet agents, anticoagulants,
cobalt chromium alloy, polymer matrix, sirolimus, or their derivatives.
• Death
Drève Richelle 161 H
1410 Waterloo
BE
Drève Richelle 161 H
1410 Waterloo
BE
Listed location countries
Age
Inclusion criteria
1. Subject has atherosclerotic coronary artery disease with an indication for stent implantation;
2. Target lesion(s) with a diameter stenosis of minimally 50% (visual estimate) OR a functional study documenting the hemodynamic relevance of the target lesion(s);
3. All target lesion(s) require treatment with stents having diameters from 2.5mm to 3.5mm (visual estimate);
4. Subject is >=18 years of age;
5. Subject must sign Ethics Committee approved informed consent prior to undergoing any study specific procedure;
6. Subject must be willing and able to comply with specified follow-up schedule.
Exclusion criteria
1. Planned medical procedures or concomitant disease requiring modification of DAPT regimen within 6 months of enrollment into this study;
2. Women of childbearing potential without negative pregnancy test within 7 days before enrollment OR women who do not agree to remain on birth control until angiographic follow-up at 13 months if applicable OR lactating women. For women of childbearing potential, requiring an acute, non-elective procedure, a verbal confirmation of non pregnancy and birth control is sufficient;
3. Currently participating in an investigational study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
Design
Recruitment
Medical products/devices used
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 | NL28651.078.09 |