Clinical Trials Core

Medtronic Valiant Evo US Clinical Trial

The purpose of this study is to investigate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm who are candidates for endovascular repair.

Stanford is currently accepting patients for this trial.

Lead Sponsor: Medtronic Vascular, Inc.

Stanford Investigator(s):  Jason Lee, MD

Intervention(s):  Device: Valiant Evo Thoracic Stent Graft System

Medtronic Endurant Evo AAA Stent Graft System for Endovascular Treatment of Infrarenal Abdominal Aortic Aneurysms

The primary safety objective is to demonstrate the safety of the Endurant Evo AAA stent graft system for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. Safety will be assessed through the proportion of subjects who have a Major Adverse Events (MAE) reported within 30-days post implantation. 

The primary effectiveness objective is to demonstrate successful delivery and deployment of the Endurant Evo AAA stent graft system with successful removal of the delivery system during the index procedure as well as the treatment success at 12 months.

Study is closed to enrollment, and is in follow-up.

Lead Sponsor: Medtronic Vasular, Inc.

Stanford Investigator (s): Jason Lee, MD

Intervention (s):  Device: Endurant Evo AAA stent graft system

Post Approval Study Evaluating the Long-Term Safety and Effectiveness of the Endurant Stent Graft System (ENGAGE PAS)

The purpose of the study is to demonstrate the long-term safety and effectiveness of the Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms.

Study is closed to enrollment, and is in follow-up.

Lead Sponsor: Medtronic Vascular, Inc.

Stanford Investigator(s):  Ronald Dalman, MD 

Intervention(s):  Device: Endurant Evo Stent Graft System

'GREAT' Global Registry for Endovascular Aortic Treatment Outcomes Evaluation

The goal of this registry is to collect information on individuals treated with endovascular grafts. The information collected will be used for reporting any positive or negative effects on the use of these devices in subjects from the time of treatment through up to 10 years of follow-up. The registry team hopes to learn more about the performance of these devices in subjects over time in order to improve care.

Study is closed to enrollment, and is in follow-up.

Lead Sponsor:  W.L. Gore & Associates, Inc.

Study Invesigator(s): Jason Lee, MD

Registry study so no intervention.

A Phase 2b, Randomized, Blinded and Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Longeveron Allogeneic Human Mesenchymal Stem Cells (LMSCs) Infusion in Patients with Aging Frailty

The primary objective is to determine whether intervention with Longeveron Allogenic Human Mesenchymal Stem Cells has a beneficial effect on functional mobility and exercise tolerance compared to placebo in patients with aging frailty. 

The secondary objective is to assess the effect of LMSCs on physical performance and function-specific Patient-Reported Outcome (PRO), and the association with the Six Minute Walk Test (6MWT), and to assess the effect of LMSCs on TNF-α, and the association with 6MWT.

Stanford is not accepting patients for this study. This study is still in the initial start-up process.

Lead Sponsor: Longeveron, LLC

Stanford Investigator (s): Joseph Wu, MD, PhD

Intervention (s): Longeveron Allogeneic Human Mesenchymal Stem Cells

Sex Differences in Symptomatic Non- Obstructive Coronary Disease: Do Women Have a Unique Coronary Pathophysiology?

The objective of this research project is to determine if the incidence of chest pain suggestive of angina but 
normal-appearing coronary arteries on angiography and myocardial bridge is truly higher in women than it is in men.

Stanford is currently accepting patients for this trial.

Cardiovascular Medicine is funding this study.

Study Investigator: Jennifer Tremmel, MD

Registry study so no intervention.

FAST-FFR: FFRangio Accuracy vs. Standard FFR

The primary objective of this trial is to estimate the efficacy of the Cathworks device in measuring FFR obtained from angiography compared to the reference standard Invasive FFR for diagnosing hemodynamically significant coronary stenosis. Efficacy will be measured primarily by sensitivity and specificity.

Stanford is not accepting patients for this study. This study is still in the initial start-up process.

Lead Sponsor: Cathworks Inc.

Study Investigator: William Fearon, MD

Registry study so no intervention.

Medtronic Product Surveillance Registry

The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.

Study is open to enrollment.

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Stanford Investigator: Ronald Dalman, MD 

All Medtronic market-released leads and all market-released IPG, ICD and CRT devices are eligible to be included in this study.

Cook p-Branch

The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.

Study is open to enrollment.

Lead Sponsor: Cook Group Incorporated

Stanford Investigator(s): Jason Lee, MD 

Intervention(s): Device: Zenith® p-Branch®

Endovascular treatment using the Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents 

Cook Preserve II

The purpose of this study is to evaluate the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the commercially available Atrium iCAST™ covered stent in patients with endovascular aneurysm repair.

Study is open to enrollment.

Lead Sponsor: Cook Group Incorporated

Stanford Investigator: Jason Lee, MD 

Intervention(s): Zenith® Branch Endovascular Graft-Iliac Bifurcation

Cook Zilver® PTX® Drug-Eluting Peripheral Stent

The Zilver® PTX® Drug-Eluting Peripheral Stent has been approved by the U.S. Food and Drug Administration (FDA) to treat narrowing of the femoropopliteal (leg) arteries.

Study is closed to enrollment.

Lead Sponsor: Cook Group Incorporated

Stanford Investigator: Jason Lee, MD 

Intervention(s):  Zilver® PTX® Drug-Eluting Peripheral Stent

Zenith® Low Profile AAA 

The objective of the study is to evaluate the safety and effectiveness of the Zenith Low Profile AAA Endovascular Graft used in conjunction with the Zenith Spiral-Z AAA Iliac Leg Graft.

Study is closed to enrollment.

Lead Sponsor: Cook Group Incorporated

Stanford Investigator: Jason Lee, MD 

Intervention(s): Zenith® Low Profile AAA 

W. L Gore IBE

The purpose of this Research Study is to determine the safety and effectiveness of the GORE® EXCLUDER® Iliac Branch Endoprosthesis when used for treatment of Common Iliac Artery Aneurysms (CIAA) or Aorto-iliac Aneurysms.

Study is closed to enrollment.

Lead Sponsor: W. L Gore

Stanford Investigator: Jason Lee, MD 

Intervention(s):  The GORE® EXCLUDER® Iliac Branch Endoprosthesis

W. L Gore Cormformable

The GORE® EXCLUDER® Conformable AAA Endoprosthesis (Conformable EXCLUDER, or CEXC Device) was developed for the safe and effective treatment of patients with a minimum aortic neck length of 10 mm and neck angle of up to 90 degrees. 

Study is in the startup process.

Lead Sponsor: W.L Gore

Stanford Investigator: Jason Lee, MD

Intervention(s): The GORE® EXCLUDER® Conformable AAA 

Endologix LUCY

The primary objectives of the LUCY Study are to demonstrate the clinical benefits associated with endovascular repair using the low profile (14F) Ovation Prime Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft in female patients.

Study is closed to enrollment.

Lead Sponsor: Endologix

Stanford Investigator: Jason Lee, MD 

Intervention(s): Ovation Prime Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft

Endologix Leopard

The LEOPARD study is a prospective, randomized, multi-center study, intended to evaluate the outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world populations.

Study is enrolling.

Lead Sponsor: Endologix

Stanford Investigator:  E. John Harris, MD

Intervention(s): The study is designed to compare the anatomically 

Stabilized AFX Endograft System to a reference group of proximally fixated EVAR devices.