The Division of Vascular Surgery at Stanford University Medical Center has a strong committment to investigations involving novel therapies and devices to treat patients with vascular disease. There is a rich history of this within our institution and we continue to participate in numerous clinical trials involving novel drug therapies, budding technology, and vascular health-related outcomes that patients from both Stanford and the nearby Veterans Affairs Medical Center can become involved with. Please contact the individual Principal Investigators listed below or their study coordinators for more information regarding a particular trial. Thank you again for your interest in our program and we hope to continue to be on the frontier of new treatment opportunities to optimize vascular health in our patients.
| AAA: STOP - Abdominal Aortic Aneurysms: Simple Treatment or Prevention |
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| Principal Investigator |
Ronald L. Dalman, MD |
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| Purpose of Research |
The goal of this study is to gather information on AAA risk factors and determine whether and exercise program reduces the rate of AAA enlargement. |
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| Protocol Summary |
The first part of the study will assess lifetime physical activity and medical history through two questionnaires. Patients will also have an ultrasound for a standardized measurement of aortic diameter and complete lab work. This part of the study is completed in one morning. If patients are interested in the exercise study and are eligible, they will be randomized to exercise or the usual activity control group. The part of the study requires a three year commitment. |
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| Basic Eligibility Criteria |
Men and women over the age of 50 with small infrarenal AAA less than 5.5 cm in diameter. |
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| Contact Information |
Julie White, AAA STOP Program Coordinator
(650) 498-6039
juliejohnsonwhite@stanford.edu
http://aaastop.stanford.edu |
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| Claudication Drug Trials |
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| Purpose of Research |
This study tests the experimental drug, Ad2/HIF-lalpha/VP16, which is designed to encourage the growth of healthy new blood vessels to improve circulation to the legs |
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| Basic Eligibility Criteria |
Men and women age 40-80. |
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| Contact Information |
Please call 650-724-8292 for more information. |
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CORAL: Cardiovascular Outcomes in Renal Atherosclerotic Lesions - NIH |
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| Principal Investigators |
Jason T. Lee, MD - Stanford
Wei Zhou, MD - VAPAHCS |
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| Purpose of Research |
To test the hypothesis that medical therapy with stenting of significant renal artery stenoses in patients with systolic hypertension reduces the incidence of adverse cardiovascular and renal events compared with medical therapy alone. |
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| Protocol Summary |
This study will enroll patients with a history of systolic hypertension, who have documented renal artery stenosis. Patients will be randomized via several pathways to either medical therapy or medical therapy with renal artery stenting and be closely monitored for blood pressure control and management of other risk factors. Subjects in both groups will be followed up to 5 years. |
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| Basic Eligibility Criteria |
Subjects must be >18 years of age with documented history of hypertension on ≥ 2 antihypertensive medications. |
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| Contact Information |
Stephanie Siu, Clinical Study Coordinator at Stanford
(650) 498-7936
stephsiu@stanford.edu |
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Dona Bahmani, Clinical Research Coordinator at VAPAHCS
(650) 849-0357
doghdoo.bahmani@va.gov |
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Detection of Colon Ischemia in AAA Repair – Spectros |
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| Principal Investigator |
Jason T. Lee, MD |
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| Purpose of Research |
To find out if the Spectros G.I. Oxygenation Probe with their T-Statâ unit can determine which patient is at risk for colon ischemia. |
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| Protocol Summary |
All participants will be treated with the same procedure of having the study device inserted during the scheduled procedure. The T-Stat monitor and probe for detecting ischemia has received 510(k) approval for use from the FDA. |
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| Basic Eligibility Criteria |
Subjects scheduled for AAA repair and AFB procedure. |
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| Contact Information |
Stephanie Siu, Clinical Study Coordinator
(650) 498-7936
stephsiu@stanford.edu |
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PIVOTAL: Positive Impact of endoVascular Options for Treating Aneurysm earLy - Medtronic |
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| Principal Investigator |
Jason T. Lee, MD |
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| Purpose of Research |
To compare endovascular repair versus surveillance, with respect to patient survival, AAA rupture, and AAA related death. |
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| Protocol Summary |
Subject will be randomized into endovascular repair group or surveillance group. For subjects assigned to endovascular group, they will be treated by any FDA approved Medtronic AAA Vascular Stent Graft System. Subjects in both groups will be followed up to 5 years. |
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| Basic Eligibility Criteria |
Subject is > 40 to 90 years of age and aneurysm diameter of 4 - 5 cm. |
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| Contact Information |
Stephanie Siu, Clinical Study Coordinator
(650) 498-7936
stephsiu@stanford.edu |
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PROOF: Plaque RemOval versus Open Bypass Surgery For Critical Limb Ischemia – FoxHollow Technologies |
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| Principal Investigators |
Jason T. Lee, MD - Stanford
Wei Zhou, MD - VAPAHCS |
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| Purpose of Research |
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs. |
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| Protocol Summary |
Subject will be randomized into the bypass or plaque excision group. For the subjects assigned into plaque excision group, they will be treated with SilverHawk Plaque Excision System. Subjects in both groups will be followed up to 5 years. |
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| Basic Eligibility Criteria |
Subjects must be >18 years of age and have ischemic rest pain for more than 2 weeks or ulceration or gangrene of the foot or toes (Rutherford Becker Category 4, 5 or 6). |
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| Contact Information |
Stephanie Siu, Clinical Study Coordinator - Stanford
(650) 498-7936
stephsiu@stanford.edu |
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Dona Bahmani, Clinical Research Coordinator at VAPAHCS
(650) 849-0357
doghdoo.bahmani@va.gov |
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PROTECT: PROTECTed Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) – Abbott Vascular |
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| Principal Investigators |
Ronald L. Dalman, MD - Stanford
Wei Zhou, MD - VAPAHCS |
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| Purpose of Research |
To evaluate the long-term safety, efficacy and durability of the Xact® Rapid Exchange Carotid Stent System used in conjunction with the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5) and the Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3), in the treatment of atherosclerotic carotid artery disease in high-surgical risk subjects. |
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| Protocol Summary |
All participants will be treated with the same procedure, no randomization is required. Subjects will be followed at 30 days, 12 months and annually thereafter for a total of three years. |
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| Basic Eligibility Criteria |
The subject must be >18 years of age with carotid artery stenosis who are at high risk for carotid endarterectomy and are candidates for percutaneous angioplasty and stenting. |
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| Contact Information |
Stephanie Siu, Clinical Study Coordinator - Stanford
(650) 498-7936
stephsiu@stanford.edu |
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Dona Bahmani, Clinical Research Coordinator at VAPAHCS
(650) 849-0357
doghdoo.bahmani@va.gov |
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PYTHAGORAS: Prospective aneurYsm Trial: High AnGle Aorfix™ bifurcAted Stent graft – Lombard Medicals |
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| Principal Investigator |
Jason T. Lee, MD |
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| Purpose of Research |
To evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft range in aneurysms with anatomy including angled aorta, angled aneurysmal body or both, where the patients have suitable anatomy. |
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| Protocol Summary |
Participants will be assigned to open or endovascular arms by their study doctor based on their eligibility for either group. For the subjects assigned into endovascular group, they will be treated with Aorfix™ AAA bifurcated stent graft. Subjects in both groups will be followed up to 2 years. Additional post-market follow-up will be yearly out to 5 years for the cohort of patients. |
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| Basic Eligibility Criteria |
Subject is > 21 to 85 years of age with diagnosed abdominal aortic aneurysm with aortic neck angles up to 90°, > 4.5 cm in diameter. |
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| Contact Information |
Stephanie Siu, Clinical Study Coordinator
(650) 498-7936
stephsiu@stanford.edu |
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| Small Aneurysm Study |
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| Principal Investigator |
Ronald L. Dalman, MD |
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| Purpose of Research |
This study examines the effect of blood flow on AAA progression and pathogenesis. |
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| Protocol Summary |
All patients will undergo abdominal ultrasound imaging and magnetic resonance imaging. |
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| Basic Eligibility Criteria |
We are seeking subjects for three patient groups: (1) Spinal Cord Injury patients who are non-ambulatory for at least 5 years, (2) patients with small, infrarenal AAA's (< or = 4.0 cm), and (3) control patients with no history of aneurysmal disease. All subjects must be at least 55 years of age; both males and females are being recruited. |
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| Contact Information |
Janice Yeung , MD
(650)724-7582
jyeung@stanford.edu |
