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Open Versus Endovascular Repair of Popliteal Artery Aneurysm Trial

NCT01817660 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-01-13

No results posted yet for this study

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 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.

Conditions

  • Popliteal Artery Aneurysm

Interventions

PROCEDURE

Open repair of popliteal artery

PROCEDURE

Endovascular repair of popliteal artery

Sponsors & Collaborators

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Alik Farber, MD · Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01817660 on ClinicalTrials.gov