Devices

Research  Devices

SAVAL

A randomized study comparing the (DES) stent (BTK) Vascular Stent System versus Percutaneous Transluminal Angioplasty (PTA) treating infrapopliteal Lesions in Subjects with Critical Limb Ischemia.

COMING SOON!

Primary Investigator:
Steve Henao, MD, FACC, FACS

Sub-Investigators
Richard Wilkerson, MD, RPVI
Trent Proffitt, MD


PIONEER III

The primary objective is to demonstrate the safety and efficacy of The BuMA Supreme™ Biodegradable Drug Coated Coronary Stent System in patients with functionally significant ischemia requiring percutaneous coronary intervention (PCI) with implantation of drug eluting stents for the treatment of stable coronary artery disease or acute coronary syndromes without ST-segment elevation (unstable angina [UA] and non-ST-segment elevation myocardial infarction [NSTEMI]) by randomized comparison with commercially-available durable polymer everolimus-eluting stent systems.

PHASE: Enrolling

Primary Investigator:
Geoffrey Kunz, MD, FACC

Sub-Investigators:
Charles Kim, MD, FACC
Mark Bieniarz, MD, FACC, FSCAI
Raymond Yau, MD


OASIS 9

A 2 x 2 factorial randomized controlled trial of CoLchicine and spironolactonE in patients with ST elevation myocARdial infarction/SYNERGY Stent Registry – Organization to Assess Strategies for Ischemic Syndromes 9.

COMING SOON!

Primary Investigator:
Mark Bieniarz, MD, FACC, FSCAI

Sub-Investigators:
Charles Kim, MD, FACC
Raymond Yau, MD
Geoffrey Kunz, MD, FACC


ECLIPSE

Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts) To evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting

COMING SOON!

Principle Investigator:
Geoffrey Kunz, MD, FACC

Sub-Investigators
Mark Bieniarz, MD, FACC, FSCAI
Charles Kim, MD, FACC
Raymond Yau, MD


BRADY MRI

Evaluate long-term safety of the FDA approved St. Jude Medical Tendril MRI™ lead implantation with a SJM Brady MRI implantable pulse generator such as the Accent MRI™, Assurity MRI™, Endurity MRI™ pacemaker, or similar model (SJM Brady MRI System) in subjects with a standard bradycardia pacing indication. Study visits are every 6 months alternating in office and phone for up to 60 months.

PHASE: Enrolling

Principal Investigator:
Michael Bestawros, MD, MPH

Sub-Investigators:
Sean Mazer, MD, FHRS, FACC
Yaw Adjei-Poku, MD
Laura McDermott, CNP, MSN, CACP
Brad Gwyther, MS, PA-C


ST. JUDE’S LEADS ASSESSMENT (CLAS)

A study involving the Riata/Riata ST silicone endocardial leads made by St. Jude Medical. This study does not involve any investigational product (medical device) or procedures.

PHASE: Follow Up (not accepting any new patients)

Principal Investigator:
Sean Mazer, MD, FHRS, FACC

Sub-Investigators:
Michael Bestawros, MD, MPH
Fernando Tondato, MD