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Los Angeles, CA. 90048
Phone: 310-652-8132

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Santa Monica, CA 90404
Phone: 310-315-5765

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Clinical Research Trials

Vascular Surgery Associates (VSA) has a long tradition of publishing clinical research based on reviews of standard surgical procedures. Over one hundred scientific papers have been published by the members of VSA on a variety of vascular surgical topics. Recent involvement with multi-institutional clinical trials provides our patients access to exciting new therapies before these treatments become widely available.

For information regarding any trial, contact our research coordinator 310-652-8132


 

Trial Name:   Best Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ishcmia (BEST-CLI) is a Multicenter randomized clinical trial

Sponsor: NIH (https://clinicaltrials.gov/ct2/show/NCT02060630)

Status: Currently Enrolling

Summary: This study seeks to answer the question whether an open bypass operation or endovascular revascularization is the better treatment option in patients with critical limb ischemia (pain in the leg at rest with or without an open wound).

Eligible Patients: Patients with peripheral arterial disease below the level of the groin with evidence of critical limb ischemia by physical exam and testing who are candidates for either open surgery or endovascular revascularization.


Trial Name: Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) is a multi-center randomized observer-blinded endpoint trial

Sponsor: NIH (www.crest2trial.org)

Status: Currently Enrolling

Summary: Patients without neurological symptoms and a narrowing of the carotid artery are recommended to undergo endarterectomy or stenting depending on how narrow the vessel has become and their individual anatomy. This study examines whether maximal medical therapy , which involves blood pressure control, LDL cholesterol management and smoking cessation is as effective alone or in conjuction with either carotid endarterectomy or stenting in preventing stroke.

Eligible Patients: Any patient over the age of 35 with an asymptomatic high grade narrowing (>70% by ultrasound or angiography) of at least one carotid artery is elibible for enrollement.


Trial Name: A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of the Ex-Vivo Treatment With CGT003 of Peripheral Vein Grafts in Patients Undergoing Peripheral Arterial Bypass Graft Procedures.

Sponsor: Corgentech, Inc.

Status: Trial completed. Study showed no effect of gene therapy on graft patency

Summary: The long-term results of bypasses in the legs, using the patients’ own vein, are limited by narrowings that develop months to years after the operation. The purpose of this study is to test the safety and effectiveness of an experimental drug in preventing graft narrowing or occlusion that could result in amputation. The drug is a form of gene therapy used to treat the patients’ vein during the operation.

Eligible Patients: Patients who need bypass surgery of the leg for treatment of critical lack of circulation.


Trial Name: REACH: An International Prospective Observational Registry in Subjects at Risk of Atherothrombotic Events

Sponsor: Bristol-Myers Squibb/ Sanofi Partnership

Status: Closed to enrollment. 58,000 patients enrolled worldwide

Summary: The purpose of this study is to collect data on patients with blockages of arteries to the heart, brain or legs. This epidemiologic study is intended to provide long term comprehensive data on risk factors for stroke, heart attack and peripheral arterial disease.

Eligible Patients: Patients who have had a heart attack, stroke or leg circulation problem who have several risk factors, such as diabetes, hypertension, high cholesterol or cigarette smoking.


Trial Name: Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of AMG 0001 to improve Perfusion in Critical Leg Ischemia.

Sponsor: AnGes Inc.

Status: Enrollment Closed

Summary: The purpose of this study is to test the safety and effectiveness of a drug to stimulate new circulation in the legs of patients with severe arterial blockages. The drug is a form of gene therapy, or angiogenesis, which causes new blood vessels to grow in the legs of patients who would otherwise be at risk for an amputation.

Eligible Patients: Patients with critical lack of circulation in the leg who are not good candidates for standard bypass surgery. Symptoms caused by the peripheral arterial disease may be pain in the foot at night or a nonhealing ulcer or wound of the foot.


Trial Name: A comparative Evaluations of Human Thrombin vs. Bovine Thrombin in achieving hemostasis in patients undergoing cardiovascular, neurologic (spine) and general surgery procedures.

Sponsor: Ethicon Inc.

Status: Enrollment Closed

Summary: Thrombin is a liquid that is derived from blood and is commonly used to help stop bleeding from small blood vessels or needle holes in arteries during surgery. The most common source of thrombin is from cows (bovine). This study is designed to evaluate the effectiveness of human-derived thrombin for the same uses during cardiovascular, spine or general surgery operations.

Eligible Patients: Patients undergoing any peripheral vascular operation where thrombin is commonly used to control intraoperative bleeding, such as aneurysm repair, leg bypass or dialysis surgery.


Trial Name: Pivotal Study Protocol: Clinical Study Comparing Expedial™ and ePTFE Vascular Access Grafts

Sponsor: LeMaitre Vascular Inc

Status: Enrolling Closed

Summary: Patients with end-stage kidney disease are usually treated with hemodialysis. Dialysis machines take blood continuously removed from the patient and filter out toxins before returning the blood to the circulation. In order to get access to the patient’s circulation a connection is made between an artery and vein. The best option is to use the patient’s own vein for this connection, or fistula. However, many patients do not have veins large enough to use for this purpose. In this situation, a plastic tube is placed under the skin to connect the blood vessels and allow access to the circulation. This study is designed to compare a new graft that has desirable properties to the standard PTFE dialysis graft.

Eligible Patients: Patients who need placement of an artificial graft for hemodialysis access.

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