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REPRISE IV is a prospective, multicenter single-arm study designed to evaluate the safety and effectiveness of the LOTUS Edge Valve System for TAVR in symptomatic subjects who have severe native aortic stenosis and are considered at intermediate risk for surgical valve replacement.

Primary Investigator: Michael Salinger, MD
Subinvestigators: Peter Mason, MD; Paul Pearson, MD; Joshua Meskin, MD

ClinicalTrials.gov Identifier: NCT03618095
Status: Currently Enrolling

The purpose of the study is to assess the feasibility of treating peripheral arterial disease (PAD) with a drug coated balloon along with removal of the plaque using the JetStream XC atherectomy system when compared to a drug coated balloon only. Arteries are reassessed at 1 month, 6 months, 1 year, 2 year and 3 years after treatment.

Primary Investigator: Robert A. Hieb, MD, RVT, FSIR
Subinvestigators: Michael J. Malinowski, MD; Parag J. Patel, MD, MS; Peter J. Rossi, MD

ClinicalTrials.gov Identifier: NCT03206762
Status: Currently Enrolling

Evaluates the clinical efficacy and safety of the IASD System II in symptomatic heart failure patients with an LV ejection fraction ≥40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT).

Primary Investigator: Michael Salinger, MD

Status: Currently enrolling

The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate aortic stenosis (AS) compared with optimized heart failure therapy (OHFT).

Primary Investigator: Michael Salinger, MD
Subinvestigator: Nunzio Gaglianello, MD; Ishizawar, David, MD

Status: Currently enrolling

To establish the safety and effectiveness of the Edwards SAPIEN 3 (Edwards Lifesciences, Irvine, California) Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis

Primary Investigator: Peter Mason, MD
Subinvestigator: Michael Salinger, MD; Paul Pearson, MD; Joshua Meskin, MD; Marc Lazzaro, MD; Panayotis Fasseas, MD

Status: Currently enrolling

Determine if the use of imaging-guided endovascular therapy (EVT) is an effective strategy with which to reduce Post-Thrombotic (PTS) disease severity and improve quality of life (QOL) in patients with established disabling iliac-obstructive post-thrombotic syndrome (DIO-PTS).

Primary Investigator: Eric J. Hohenwalter, MD, FSIR

Status: Currently enrolling

To determine whether daily supplementation with the probiotic Lactobacillus plantarum 299v improves the function of blood vessels in patients with coronary artery disease.

Primary Investigator: Michael Widlansky, MD, MPH

Status: Open to enrollment 

The purpose of this study is to evaluate whether the 50cc TAH-t can support patients who are imminent risk of death from biventricular heart failure, are eligible for heart transplantation, and for whom the 70cc TAH-t is not appropriate due to size of the chest cavity.

Primary Investigator: David Joyce, MD
Sub-investigators: Lyle Joyce, MD, PhD; Lucian Durham, MD, PhD; Paul Pearson, MD, PhD; Chris Rokkas, MD

Status: Open to enrollment 
 

The purpose of this study is to assess among patients with an acute myocardial infarction and a hemoglobin concentration less than 10 g/dL, if a liberal transfusion strategy with a threshold of 10 g/dL reduces the rate of the composite outcome of all-cause mortality or recurrent nonfatal acute myocardial infarction through 30 days following randomization compared to a restrictive transfusion strategy with a threshold of 7 to 8 g/dL.

Primary Investigator: Michael Gitter, MD
Subinvestigators: Matthew Karafin, MD; Nicole Lohr, MD, PhD; David S. Marks, MD, MBA

Status: Currently enrolling

The purpose of this study is to improve walking distance in patients with intermittent claudication by using ischemic preconditioning.

Investigators: Kellie Brown, MD; Brian Lewis, MD, Michael Malinowski, MD; Peter Rossi, MD, Matt Durand, MD; Julie Freed, MD; and David Gutterman, MD

Status: Currently enrolling

The purpose of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with traumatic injury of the descending thoracic aorta (DTA).

Investigators: Peter Rossi, MD; Kellie Brown, MD; Robert Hieb, MD, Brian Lewis, MD; Michael Malinowski, MD, Parag Patel, MD, MS; William Rilling, MD, Sarah White, MD, MS

Status: Currently Enrolling

The BEST-CLI Trial is a multicenter randomized trial of best endovascular (EVT) or best open surgical (OPEN) revascularization in patients with CLI and infrainguinal peripheral arterial occlusive disease (PAOD) who are candidates for both open and endovascular treatment.

Primary Investigators: Parag J. Patel; MD, MS, FSIR
Subinvestigators: Robert A. Hieb, MD, RVT, FSIR; Peter J. Rossi, MD; Kellie Brown, MD; Brian Lewis, MD; Michael Malinowski, MD

Status: Currently enrolling

The purpose of this research study is to evaluate whether the TAH-t can support patients with life-threatening irreversible biventricular heart failure who are not eligible for transplantation.

Primary Investigator: David Joyce, MD
Subinvestigators: Lyle Joyce, MD, PhD; Lucian Durham, MD, PhD; Paul Pearson, MD, PhD; Chris Rokkas, MD

Status: Open to enrollment