Study Stopped
Due to unsuccessful trial accrual
Open Versus Endovascular Repair of Popliteal Artery Aneurysm Trial
OVERPAR
Sponsor study identifier
interventional
6
1 country
1
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2017
Actual (reported)Study Completion
January 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
March 21, 2013
Actual (reported)March 25, 2013
Actual (reported)January 2017
Actual (reported)January 2017
Actual (reported)The primary endpoint is major adverse limb events-free survival
Patients are observed and the two groups are compared for lack of major adverse limb events; above ankle amputation of the index limb or major reintervention-new bypass graft, jump/interposition graft revision, or thrombectomy/ thrombolysis.
Patients are expected to be followed for an average of 2.5 years
Clinical Secondary outcomes:
Average follow-up is expected to be 2.5 years
Functional quality of life
Average patient follow-up is expected to be 2.5 years
Resource Utilization
Average follow-up of every patient is expected to be 2.5 years.
In this arm, patients randomized to open surgical repair of popliteal artery aneurysm (OPAR).
In this arm, patients randomized to endovascular repair of popliteal artery aneurysm (EPAR).
Boston Medical Center
Boston, Massachusetts, 02118, United States
Alik Farber, MD
Boston Medical Center
6 participants (actual enrollment reported by the registry).
First Submitted
March 21, 2013
First Posted
March 25, 2013
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Screening for Abdominal Aortic Aneurysm and Popliteal Artery Aneurysm
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 2017
Actual (reported)Study Completion
January 2017
Actual (reported)Last Updated
January 13, 2017
Record last verified: 2017-01
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Source: ClinicalTrials.gov.
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