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Current Clinical Trials

OPEN TO ENROLLMENT: US ERI (Endoleak Risk Index): Validation of Numerical Simulation to assess Type IA endoleak following endovascular aortic aneurysm repair (EVAR). Initial IRB Review: 07/10/26. SIV: 07/30/26.
  1. Kush Sharma, MD
    Kush Sharma, MD
  2. for people 18 Years and up (full criteria)
  3. Rancho Mirage, CA
  4. study started August 2026
  5. Kush Sharma, MD
  6. Accepting new patients

Description

Summary

The purpose of this study is to assess the accuracy of a new numerical simulation algorithm in evaluating the risk of peri-operative or post-procedural type IA endoleaks (EL1A) EL1A following endovascular aortic aneurysm repair (EVAR) with or without EA. This method, based on finite element analysis, enables to compute mechanical interactions between the endograft and the patient-specific digital model derived from pre-op CT. Initial IRB Review: 07/10/26. SIV: 07/30/26.

Official Title

OPEN TO ENROLLMENT: US ERI (Endoleak Risk Index): Validation of Numerical Simulation to assess Type IA endoleak following endovascular aortic aneurysm repair (EVAR). Initial IRB Review: 07/10/26. SIV: 07/30/26.

Keywords

The study population consists of a retrospective analysis of 207 patients treated with Medtronic ENDURANT endograft without (group 1; N=147) or with (group 2; N=60) EA for aorto-iliac aneurysms.

Eligibility

for people 18 Years and up
Inclusion Criteria: Any patient treated for an aorto-iliac aneurysm using a Medtronic Endurant aortic endograft with or without EA. Patients with EL1A (Group 1a and 2a), or without EL1A and at least 3 years of follow-up (Group 1b and 2b) will be eligible for inclusion. In group 2, patients who underwent primary EA procedure only will be considered for inclusion.Exclusion Criteria: Patients with inadequate preoperative imaging will be excluded: Preoperative CT scan unavailable or with no/poo... more
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Inclusion Criteria: Any patient treated for an aorto-iliac aneurysm using a Medtronic Endurant aortic endograft with or without EA. Patients with EL1A (Group 1a and 2a), or without EL1A and at least 3 years of follow-up (Group 1b and 2b) will be eligible for inclusion. In group 2, patients who underwent primary EA procedure only will be considered for inclusion.

Exclusion Criteria: 

Patients with inadequate preoperative imaging will be excluded: Preoperative CT scan unavailable or with no/poor quality arterial phase contrast injection; Preoperative CT scan with artifacts at the level of the abdominal aorta (for example lumbar spine metallic implants); Preoperative CT scan with slice thickness greater than 5 mm

Patients with inadequate post-operative imaging will be excluded: Post-operative CT scan unavailable or with no/poor quality arterial phase contrast injection; Post-operative CT scan with artifacts at the level of the abdominal aorta (for example lumbar spine metallic implants)

Patients with secondary EA procedure will be excluded.

Patients with aorto-uni-iliac Endurant stent-graft will be excluded.

Lead Scientists at Eisenhower Health

Kush Sharma, MD
Kush Sharma, MD, is a Board Certified Vascular Surgeon with additional certification as a Registered Physician in Vascular Interpretation (RPVI). He is a Fellow of the American College of Surgeons, a designation provided to surgeons who have commitment to professional excellence, integrity and high standards of surgical care. He sees patients in Rancho Mirage at the Eisenhower Vascular Clinic.Originally from Kalamazoo, Michigan, he completed his undergraduate studies at the University of Michiga... more
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Kush Sharma, MD, is a Board Certified Vascular Surgeon with additional certification as a Registered Physician in Vascular Interpretation (RPVI). He is a Fellow of the American College of Surgeons, a designation provided to surgeons who have commitment to professional excellence, integrity and high standards of surgical care. He sees patients in Rancho Mirage at the Eisenhower Vascular Clinic.

Originally from Kalamazoo, Michigan, he completed his undergraduate studies at the University of Michigan in Ann Arbor, Michigan, before joining the inaugural medical school class at Central Michigan University in Mount Pleasant, Michigan. He went on to complete his integrated vascular surgery residency through Michigan State University College of Human Medicine at Spectrum Health in Grand Rapids, Michigan. During his training, he authored several peer-reviewed articles and book chapters and was invited to present his research at numerous national and international conferences.

Dr. Sharma’s interest in medicine began early, inspired by accompanying his grandparents to their medical appointments. “Watching how their vascular surgeon cared for them during difficult times made a lasting impression on me,” he shares. “It sparked my desire to become a physician and ultimately led me to vascular surgery.”

 He continues, “I chose vascular surgery because it allows me to care for patients with vascular conditions throughout the body and to follow them closely over time. I value the long-term relationships I’m able to build with my patients based on trust and continuity of care.”

 Dr. Sharma is dedicated to providing compassionate, patient-centered care, treating each patient as if they were a member of his own family. “It’s important to me to understand each patient’s concerns and goals so we can work together to create a personalized treatment plan.”

 

Dr. Sharma lives in Palm Desert with his family and enjoys playing golf, tennis and traveling in his free time.

Co-Investigators

  1. Trevor DerDerian, MD

Clinical Study Details

  1. Accepting new patients
  2. study started August 2026
  4. Observational Retrospective
  5. September 03, 2026