Lee Research Program
Personnel
- Jason T. Lee, MD: Principal Investigator
- Mediget Teshome: Postdoctoral Fellow/general surgery resident
- Shyam Raghavan: Medical Student
CORAL: Cardiovascular Outcomes in Renal Atherosclerotic Lesions - NIH
| Principal Investigator | Jason T. Lee, MD |
| 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. |
| 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. |
| Basic Eligibility Criteria | Subjects must be >18 years of age with documented history of hypertension on ≥ 2 antihypertensive medications. |
| Contact Information | Stephanie Siu, Clinical Study Coordinator |
Detection of Colon Ischemia in AAA Repair – Spectros
| Principal Investigator | Jason T. Lee, MD |
| 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. |
| 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. |
| Basic Eligibility Criteria | Subjects scheduled for AAA repair and AFB procedure. |
| Contact Information | Stephanie Siu, Clinical Study Coordinator (650) 498-7936 |
PIVOTAL: Positive Impact of endoVascular Options for Treating Aneurysm earLy - Medtronic
| Principal Investigator | Jason T. Lee, MD |
| Purpose of Research | To compare endovascular repair versus surveillance, with respect to patient survival, AAA rupture, and AAA related death. |
| 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. |
| Basic Eligibility Criteria | Subject is > 40 to 90 years of age and aneurysm diameter of 4 - 5 cm. |
| Contact Information | Stephanie Siu, Clinical Study Coordinator (650) 498-7936 |
PROOF: Plaque RemOval versus Open Bypass Surgery For Critical Limb Ischemia – FoxHollow Technologies
| Principal Investigator | Jason T. Lee, MD |
| Purpose of Research | To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs. |
| 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. |
| 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). |
| Contact Information | Stephanie Siu, Clinical Study Coordinator (650) 498-7936 |
PYTHAGORAS: Prospective aneurYsm Trial: High AnGle Aorfix™ bifurcAted Stent graft – Lombard Medicals
| Principal Investigator | Jason T. Lee, MD |
| 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. |
| 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. |
| 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. |
| Contact Information | Stephanie Siu, Clinical Study Coordinator (650) 498-7936 |
