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Vascular Research and Clinical Trials

Fairfield Medical Center is at the forefront of medical research, technology and innovative treatment techniques thanks to its cardiovascular clinical research program.

FMC has participated in numerous clinical research studies since the program’s inception and has garnered national recognition for being the first in the nation to enroll and treat patients.

All of the studies are sponsored through a company or are physician initiated, and participants are enrolled based upon the recommendation of their physician.

The LUCY Study

Krishna Mannava and Omar Al-NouriKrishna Mannava, M.D. and Omar Al-Nouri, D.O. of Fairfield Healthcare Professionals Vascular Surgery, were the first to enroll and treat a patient in the LUCY Study (TriVascular Evaluation of FemaLes who are Underrepresented Candidates for Abdominal Aortic AneurYsm Repair). TriVascular Technologies, Inc. is the manufacturer of the Ovation® Abdominal Stent Graft platform. Fairfield Medical Center is one of 45 sites selected to participate in this study.

The LUCY study is a prospective, consecutively enrolling, non-randomized multi-center post-market registry designed to evaluate the ultra-low profile (14F) Ovation platform when used in the endovascular treatment of abdominal aortic aneurysms (AAA) in female as compared to male patients. The lack of adequate treatment options, principally due to suboptimal, large bore, conventional EVAR systems, is a persistent issue for female AAA patients. Clinical literature shows that women diagnosed with AAA experience aortic expansion at a rate that is 40-80% faster than men, which can result in aortic rupture at smaller diameters. On average, women with abdominal aortic aneurysms have challenging access vessel anatomy and, often, hostile aortic neck anatomy. This fact, when combined with the technical limitations of conventional stent graft systems, results in significantly decreased access to on-label EVAR treatment for most women.

“The Ovation system is ideally suited for patients with small-diameter access vessels and diseased aortic necks, which is often characteristic of female patients. Our first LUCY case went well and we are excited to continue enrolling and, ultimately, see the results from this landmark study,”
Dr. Mannava said.

To see if your patient is eligible to participate in this study, contact Lisa Stevens, M.S.N., R.N., Clinical Research Coordinator at FMC at 740-689-4426.

ACCESS PTS Study

Principle Investigator: Krishna Mannava, M.D.
Sub-Investigator: Omar Al-Nouri, D.O.

Accelerated Thrombolysis for Post-Thrombotic Syndrome using EkoSonic Endovascular System. This study is a prospective, single arm, multi-center study to evaluate the efficacy of ultrasound accelerated thrombolysis using the EKOS catheter for treatment of chronic DVT’s.

Lidocaine-BiCarb (LiBi) Study

Principle Investigator: Jeremy Buckley, M.D.
Jeremy BuckleyLidocaine-BiCarb (LiBi) Study This study is a single-centered, blind, randomized, controlled study to determine the efficacy and use of warmed, buffered Lidocaine during groin subcutaneous local anesthesia prior to groin access for a heart cath.

Submasive Pulmonary Embolism Experience with EKOS – SPEEK Study

Principle Investigator: Krishna Mannava, M.D.
Sub-Investigator: Omar Al-Nouri, D.O.

This is a single center, non-blinded, non-randomized, prospective study, to evaluate the efficacy of ultrasound accelerated thrombolysis with standard infusion of thrombolytic drug in patients who suffer from acute Pulmonary Embolus using the EKOS catheter.

Post Approval Study (PAS Study) of the Relay Thoracic Stent-Graft with Plus Delivery System

Principle Investigator: Krishna Mannava, M.D.
Sub-Investigator: Omar Al-Nouri, D.O.

Research study for patients with Thoracic Aortic Aneurysms and Penetrating Ulcers. This study is a 28 center, non-blinded, non-randomized post approval study of the long-term performance of the Relay Thoracic Stent Graft.