This trial is active, not recruiting.

Conditions common iliac artery occlusion, external iliac artery occlusion
Treatment pi 13-05
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
pi 13-05

Primary Outcomes

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

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by W.L.Gore & Associates.