Evaluation of the GORE® PI 13-05 Device for the Treatment of Occlusive Disease in the Common and External Iliac Arteries
This trial is active, not recruiting.
|Conditions||common iliac artery occlusion, external iliac artery occlusion|
|Sponsor||W.L.Gore & Associates|
|Start date||December 2013|
|End date||January 2015|
|Trial size||30 participants|
|Trial identifier||NCT01961167, Gore PI 13-05|
The primary objective of the GORE® PI-13-05 clinical study is to evaluate the safety and efficacy of PI 13-05 for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Composite safety endpoint measured as a percentage,tallying all subjects experiencing any of the events as a failure
time frame: within 30 days of index procedure
Male or female participants at least 18 years old.
Inclusion Criteria: - Patient is at least 18 years old; - Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy; - Patient or legal representative is willing to give written informed consent; - Patient is capable of complying with protocol requirements, including all follow-up visits; - Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4). - Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery Exclusion Criteria: - Patient has a life expectancy of less than 1 year; - Patient has a known allergy to stent graft components, including stainless steel or heparin; - Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol; - Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation - Patient has had vascular access / catheterization in the lower extremity within 30 days of study enrollment; - Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure; Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the study procedure; - Patient is currently participating in this or another investigative clinical study. - Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s); - Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device; - Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery; - Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent
|Official title||Feasibility Evaluation of the GORE® PI 13-05 Device for the Treatment of Occlusive Disease in the Common and External Iliac Arteries|
|Principal investigator||Andrew Holden, MB ChB|
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