Status:
WITHDRAWN
Frontier Registry II Bifurcation Stent System Registry
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
To assess the procedural success, performance, 30-day and 6 month clinical outcome of bifurcation stenting, and the six month incidence of clinically indicated target lesion revascularization with the...
Detailed Description
The purpose of this study is to assess the performance of the Abbott Vascular MULTI-LINK FRONTIER Coronary Bifurcation Stent System (CBSS) with one and six months clinical outcomes, when used for bifu...
Eligibility Criteria
Inclusion
- Other lesions in different epicardial vessels must be successfully treated prior to bifurcation procedure.
- Native parent vessel suitable to receive at least a 2.5mm x 18mm FRONTIER stent (\>2.5mm and \<4.0mm diameter with a side branch of \>2.0mm) with a lesion length \<15mm determined by visual assessment .
- Target main branch vessel must be a major epicardial native vessel.
- Appropriate lesion morphology.
- Target lesion is restenosis following original treatment by PTCA only (no in-stent restenosis).
Exclusion
- Estimated artery reference diameter \<2.5mm
- Patients with diffuse disease defined as long segments of abnormal vessel without interposed areas of normal vessel
- Target lesion contains thrombus.
- Target lesion is aorto-ostial or left main stem location.
- Untreated lesion \>50% diameter stenosis proximal or distal to target lesion after the planned target lesion intervention.
- Patients with a contraindication for anti-platelet / anti-coagulation therapy.
- Target lesion distal to previously placed stents.
- Fibrotic or calcified lesions that cannot be pre-dilated.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00286195
Start Date
December 1 2004
End Date
December 1 2006
Last Update
May 13 2015
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