Open Versus Endovascular Repair of Popliteal Artery Aneurysm Trial

Stopped early · Not applicable

Conditions studied: Popliteal Artery Aneurysm

In brief

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 associated with significant risk of blood clot formation, narrowing of blood vessel which can create a serious threat to individual's health. Currently, approved treatment options for this condition include both open surgical and endovascular stent-graft repairs. In the open repair procedure, the blood vessel behind the knee is tied up or removed and a small artery is created using a vein on the same leg. This is also called a bypass procedure. In the endovascular repair, using X-rays, doctors places a stent in the blood vessel. Stent is a small device similar to a thin tube. When it is placed in the right location, your doctor can open it. When stent is opened, it supports weakened blood vessel and blood goes through it. The weakened artery then shrinks around the stent. The OVER-PAR is a short name for this study. Many hospitals in the United States agreed to participate in this study. Patients are randomized to undergo either open or endovascular repair because they can be treated with either of the procedures. Investigators use the short names OPAR for open surgical repair and EPAR for endovascular repair. People who have an aneurysm that is larger than 2 cm (about an inch) can participate in this study. The purpose of this study is to compare outcomes after these two standard procedures.

Key facts

Study ID

NCT01817660

Run by

Boston Medical Center

People needed

6

Starts

2013-02-01

Expected to finish

2017-01-01

Last updated by the study team

2017-01-13

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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