Status:
TERMINATED
Open Versus Endovascular Repair of Popliteal Artery Aneurysm Trial
Lead Sponsor:
Boston Medical Center
Conditions:
Popliteal Artery Aneurysm
Eligibility:
All Genders
35+ years
Phase:
NA
Brief Summary
Weakness in the wall of a blood vessel located behind the knee (popliteal artery) which leads to a swelling of this blood vessel (aneurysm) is one of the most common types of arterial aneurysms. It is...
Detailed Description
Current therapy for patients with asymptomatic PAA, elective repair has been recommended for PAA \> 2 cm and for smaller aneurysms with associated mural thrombus1. Treatment modalities are similar in ...
Eligibility Criteria
Inclusion
- Age \> 35 years
- Popliteal artery aneurysm \> 2 cm in diameter with or without presence of mural thrombus
- Candidate for either OPAR or EPAR as judged by the treating investigator.
- Greater than 2 cm length of normal superficial femoral artery distal to the deep femoral artery takeoff and \>2 cm length of normal popliteal artery proximal to the first patent tibial artery.
- Willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.
Exclusion
- Popliteal artery thrombosis
- Popliteal artery aneurysm causing symptomatic thromboembolic disease or compressive symptoms.
- Superficial femoral artery occlusion or distal tibio-peritoneal occlusion
- Less than 2 cm length of normal artery to accommodate stent graft seal
- Life expectancy of less than 2 years.
- Deemed excessive risk for surgical bypass (defined as prohibitive operative risk by formal pre-procedural cardiac risk assessment undertaken by a cardiologist or internist according to established AHA guideline criteria).
- A documented hypercoagulable state (defined as a known blood disorder associated with venous or arterial thrombosis).
- Any infrainguinal revascularization procedure on index leg within 12 weeks prior to treatment initiation.
- Current immune-suppressive medication, chemotherapy or radiation therapy.
- Absolute contraindication to iodinated contrast due to prior near-fatal anaphylactoid reaction (laryngospasm, bronchospasm, cardiorespiratory collapse, or equivalent) and which would preclude patient from participation in angiographic procedures.
- Allergy to stainless steel or nitinol.
- Pregnancy or lactation.
- Inability or refusal to provide informed consent.
- Patients who received an investigational drug for peripheral arterial disease within 4 weeks of screening or who participated in another non-observational clinical trial in the prior 30 days.
- Prior leg bypass on the ipsilateral limb
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01817660
Start Date
February 1 2013
End Date
January 1 2017
Last Update
January 13 2017
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118