Primary objective: To gather safety data regarding the clinical performance of the Xtent device in patients treated for coronary artery disease.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoint: The rate of Major Adverse Cardiac Event (MACE) at 30 days
(1 month).
Secondary outcome
Secondary Endpoints: Include MACE rate at 6 months, the incidence of bleeding
and/or vascular complications, the incidence of (sub)acute stent thrombosis
(SAT) at discharge, 30 days (1 month) and 6 months. In addition: angiographic
endpoints, device performance endpoints and other safety endpoints.
Background summary
Study Justification
The XTENT® Custom NX 60 DES Catheter System allows for customized implantation
of balloon expandable stents. This catheter system enables the physician to
adjust the stent length to the length of lesion to be treated within the
coronary vasculature. This assessment in situ is taking place in the same
setting as the stent implantation and it does not require the physician to
decide in advance the stent length to be implanted. Additionally, the XTENT®
Custom NX 60 DES Catheter system allows for the deployment of up to two drug
eluting stents per catheter. The drug eluting stents used in the Custom NX 60
DES Catheter System utilize the proven Biolimus A9 and PLA coating formulation.
While the patient risks associated with the XTENT® Custom NX 60 DES Catheter
System is similar to current DES stent and delivery systems used for coronary
revascularization, the XTENT® DES Catheter Systems should offer advantages to
current marketed products such
as:
customization of stent length in situ avoiding estimation of stent length from
fluoroscopy and possible in situ placement of suboptimal stent length,
treatment of single long lesions (up to 60 mm), longer than all currently
available DES stents,
Ability to treat more than one lesion with one catheter reducing catheter
exchange and therefore the length of the procedure and possibly the patient
exposure to radiation or additional contrast injection.
Study objective
Primary objective: To gather safety data regarding the clinical performance of
the Xtent device in patients treated for coronary artery disease.
Study design
This study is a prospective registry enrolling a target up to 110 (Ninety (90)
patients plus up to 20 roll-in) subjects at 15 European clinical sites.
Intervention
.
Study burden and risks
.
125 Constitution Drive
Menlo Park , CA 94025
US
125 Constitution Drive
Menlo Park , CA 94025
US
Listed location countries
Age
Inclusion criteria
- at least 18 years
- acceptable candidate for PTCA
- clinical evidence of ischemic heart disease
- target lesion are de novo and stenosis >50% and <100%
- reference vessel diameters >2,25 mm and < 3,75 mm.
Exclusion criteria
- left ventricular ejection fraction <30%
- history of cerebrovascular accident (CVA) or transitory ischemic attack (TIA) in prior 3 months
- evidence of an acute myocaridal infarction whose onset began within 72 hours ago
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 | NL15019.041.06 |