The primary objective is to assess the feasibility, safety and efficacy of Lutonix Catheter for treatment of de novo coronary artery stenosis using two distinct treatment strategies: Lutonix Catheter before or after BMS
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean percent stent volume obstruction at 6 months.
Secondary outcome
OCT endpoints (Quantitative assessment):
Post Procedure: Stent Malapposition; Minimal Lumen Area (MLA) [mm2]; Stent
Symmetry; Stent Expansion
At follow-up: Stent Malapposition; MLA [mm2]; Stent strut coverage
OCT endpoints (Qualitative assessment):
Post procedure: Tissue Prolapse; Residual edge dissection; Thrombus;
Angiographic endpoints:
Minimal Lumen Diameter (MLD); Late Luminal Loss (LLL); percent Diameter
Stenosis (%DS); and Restenosis Rate (RR) at follow-up of the analysis segment
as assessed by off-line Quantitative Coronary Analysis (QCA); All measuremenst
will be made of the in-stent and the analysis segment
Safety and Clinical endpoints:
Combined and individual endpoints including all cause death, cardiac death,
myocardial infarction, clinically indicated Target Lesion Revascularization
(TLR) and Target Vessel Revascularization (TVR); overall TLR and TVR
Safety endpoints, including: Stent thrombosis according tot the Academy
Research Consortium (ARC) definitions; Major and minor bleedings; other serious
adverse events
Background summary
The study will enroll approximately 24 patients presenting with
angiographically significant coronary de novo lesions. patients wil be
randomized in a 1:1 fashion to treament with either:
• Lutonix Catheter before bare-metal stenting (BMS) -or-
• Lutonix Catheter after bare-metal stenting (BMS)
Up to 10 sebjects will participate in a pharmacokinetic (PK) sunstudy during
the index hospitalization
Clkinical follow-up will occur at 1, 6, 12 and 24 months. Repeat
angiography/Optical Tomography (OCT) will occur at the 6 month clinical visit
Study objective
The primary objective is to assess the feasibility, safety and efficacy of
Lutonix Catheter for treatment of de novo coronary artery stenosis using two
distinct treatment strategies: Lutonix Catheter before or after BMS
Study design
A prospective, randomized, single-blind, European pilot study to investigate
the feasibility, safety and efficacy of the Lutonix Catheter
Intervention
The intervention is the same as usual with exception of the OCT. This is not
part of the standard procedure but is performed on regular basis during a PCI
procedure.
Study burden and risks
The risks of the PCI with OCT are the same as a regular PCI.
The repeat angiography with OCT is an extra procedure and therefore an extra
risk. Those risks are thje 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
Documented stable angina pectoris CCSC 1-4, unstable angina pectoris with documented ischemia (Braunwald 1-II) or documented silent ischemia
Target lesion is a de novo lesion in a native coronary artery vessel
Initial stenosis is >50% and <100% by visual estimate or QCA
Target lesion is <18 mm in lenght and can be treated in its entirety by no more than 1 single Lutonix Catheter balloon and 1 single BMS
Exclusion criteria
History of Stroke within past 6 months
History of MI or thrombolysis within 72 hours of randomization
Prior vascular brachytherapy
Angiographic evidece 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 | NL28123.060.09 |