Coronary Artery Disease
Conditions
Brief summary
The primary objective is to evaluate if use of the AngioGuard™ XP improves myocardial reperfusion after PTCA as assessed by ST segment resolution at the end of PTCA.
Detailed description
This is a prospective, randomized, multicenter trial. Patients will be randomized either to be treated by PTCA only or in combination with the An-gioGuard™ XP device. The patients will be followed for six-months post-procedure.
Interventions
DEVICEAngioguard distal protection device
PTCA with the Angioguard distal protection device.
OTHERPTCA
PTCA
Sponsors
Cordis US Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute myocardial infarction \< 12 hours with ST segment elevation \> 2 mm in at least 2 contiguous leads; * Clinical indication of primary PTCA; * De novo or restenotic lesions in native coronary vessel, single vessel treatment only; * Target lesion stenosis is \> 80% (by visual estimation).
Exclusion criteria
* Patient has unprotected left main coronary disease with \> 50% stenosis in case left coronary artery is treated; * Patient has an ostial target lesion; * Killip class \> 3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute ST segment resolution. | post-PTCA |
Secondary
| Measure | Time frame |
|---|---|
| TIMI Frame Count | post PTCA |
| Composite endpoint of slow flow, no reflow or distal embolization. | at anytime |
| ST segment resolution (> 50% decrease). | pre- and post-PTCA |
| Clinical success evaluation; qualitative evaluation of device and delivery system characteristics. | post-procedure |
| Cardiac function assessed by echocardiography. | before discharge and at 6 month follow-up |
| Regional wall motion index by echocardiography. | discharge and 6 month follow-up |
Countries
France
Outcome results
None listed