To assess angiographic and clinical outcomes after treatment of ISR of a prior BMS in the native coronary system with the Lutonix Catheter
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percent (%) Diameter Stenosis (DS) in the Analysis Segment at 6 months
Secondary outcome
Clinical (at 1, 6, 12 & 24 months)
- Ischemia-driven target vessel revascularization (ID-TVR) defined as targe
vessel diameter of at least 50% by Quantitative Coronary Analysis (QCA) with
either ECG changes at rest or a positive functional study in the distribution
of the target vessel, or stenosis of at least 70% irrespective of symptoms.
- Ischemia-driven target lesion revascularization (ID-TLR)
- Composite of cardiac death, myocardial infarction, and ID-TLR
- Composite of cardiac death, myocardial infarction and target vessel
revascularization TVR
- Procedural success
- Device success
Background summary
The study will enroll approximately 40 patients presenting with angiograpically
significant in-stent restenosis (ISR) of a previously placed bare-metal stent
(BMS). patients will be treated with the Lutonix Catheter. Clinical follow-up
will occur at 1, 6, 12 and 24 months. Repeat angiography/Intravascular
Ultrasound (IVUS) will occur at the 6 month clinical visit.
Study objective
To assess angiographic and clinical outcomes after treatment of ISR of a prior
BMS in the native coronary system with the Lutonix Catheter
Study design
A Prospective, Single-Arm, Multicenter, European Registry
Intervention
The intervention is the same as usual performed by patients with in-stent
restenosis with exception of the IVUS. IVUS is not part of the standard
procedure but is performed on regular basis during an PCI/
Study burden and risks
The risks of the PCI are the same as a regular PCI.
The repeat angiography is an extra procedure and therefore an extra risk. Those
risks are the same as for an regular diagnostic angiography
7351 Kirkwood Lane North, Suite 138
Maple Grove, MN 55369
US
7351 Kirkwood Lane North, Suite 138
Maple Grove, MN 55369
US
Listed location countries
Age
Inclusion criteria
Target lesions is in a native coronary with previous single bare metal stent
Stenosis is >50% and <100% by visual estimate or QCA prior to defined pre-dilatation
Exclusion criteria
History of MI or thrombolysis within 72 hours of randomization
History of previous target vessel perforation
Angiographic evidence of thrombus or dissection within the target vessel
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 | NL27997.060.09 |