Open Versus Endovascular Repair of Popliteal Artery Aneurysm Trial

NCT01817660 | Terminated DMC

• 1 other identifier: OVERPAR Trial
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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 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

Keywords

popliteal artery aneurysm; endovascular repair; open surgical repair; comparative study

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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.

Study Arms (2)

Open Surgery

ACTIVE COMPARATOR

In this arm, patients randomized to open surgical repair of popliteal artery aneurysm (OPAR).

Procedure: Open repair of popliteal artery

Endovascular Surgical repair (EPAR)

ACTIVE COMPARATOR

In this arm, patients randomized to endovascular repair of popliteal artery aneurysm (EPAR).

Procedure: Endovascular repair of popliteal artery

Interventions

Open repair of popliteal artery PROCEDURE

Also known as: Open repair.

Open Surgery

Endovascular repair of popliteal artery PROCEDURE

Also known as: Endovascular repair

Endovascular Surgical repair (EPAR)

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Popliteal Artery Aneurysm

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Officials

• Alik Farber, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 25, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: January 13, 2017

Record last verified: 2017-01

Locations

US (1)