JET RANGER
To evaluate above the Knee JETStream AtheRectomy with Adjunctive Paclitaxel-Coated BallooN Angioplasty vs Balloon AnGioplasty followed by Paclitaxel-Coated Balloon in Treating ComplEx Denovo FemoRopopliteal Arterial Disease.
COMING SOON!
Principle Investigator:
Steve Henao, MD, FACC, FACS
Sub-Investigators:
Richard Wilkerson, MD, RPVI
Trent Proffitt, MD
EVAS II
To study the safety and effectiveness of the Nellix System for Endovascular Abdominal Aortic Aneurysm (AAA) repair. Procedures will be performed per the instructions for use, and per institutional protocols and standard of care for endovascular aneurysm repair. As such, this study will evaluate the safety and effectiveness of the device system among a wide range of physicians and in consecutively enrolled subjects to assess outcomes generalizability.
COMING SOON!
Principle Investigator:
Steve Henao, MD, FACC, FACS
Sub-Investigators
Richard Wilkerson, MD, RPVI
Trent Proffitt, MD
DETOUR II
Endovascular above the knee (artery-vein-artery) bypass. The objectives of the IDE study are to evaluate the safety and effectiveness of the PQ Bypass System for access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
COMING SOON!
Principle Investigator:
Steve Henao, MD, FACC, FACS
Sub-Investigators:
Richard Wilkerson, MD, RPVI
Trent Proffitt, MD
CHOCOLATE TOUCH
A Randomized Trial to confirm the Safety and Effectiveness of Chocolate Touch® Paclitaxel Coated PTA Balloon Catheter, in Above the Knee Lesions
COMING SOON!
Principle Investigator:
Richard Wilkerson, MD, RPVI
Sub-Investigators:
Trent Proffitt, MD
Steve Henao, MD, FACC, FACS
TOBA II BTK
To evaluate the safety and efficacy of the Tack Endovascular System in subjects with below the knee (BTK) peripheral artery disease (PAD) as compared to a predefined performance goal (PG) established from published, peer reviewed scientific literature related to below-the-knee (BTK) PAD.
PHASE: Enrolling
Principal Investigator:
Steve Henao, MD, FACC, FACS
Sub-Investigators:
Richard Wilkerson, MD, RPVI
Trent Proffitt, MD
JET – ISR
The purpose of this study is to test the hypothesis that Jetstream atherectomy and adjunctive balloon angioplasty (JS +PTA) improves target lesion revascularization (TLR) at 6 months follow-up when compared to historic data from balloon angioplasty alone (PTA) in the treatment of femoropopliteal arterial In-stent restenotic (ISR) disease
PHASE: Enrolling
Principal Investigator:
Steve Henao, MD, FACC, FACS
Sub-Investigators:
Richard Wilkerson, MD, RPVI
Trent Proffitt, MD
LIMFLOW
A Pilot Study to Investigate the Safety, Effectiveness, and Feasibility of the LimFlow Stent Graft System for Creating an AV Fistula for the Treatment of Critical Limb Ischemia
PHASE: Enrolling
Principal Investigator:
Steve Henao, MD, FACC, FACI
Sub-Investigators:
Trent Proffitt, MD
Richard Wilkerson, MD, RPVI
DISRUPT RAD III
Randomized study of the Shockwave Medical Peripheral Lithoplasty® System used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries.
PHASE: Enrolling
Principal Investigator:
Steve Henao, MD
Sub-Investigators:
Trent Proffitt, MD
Richard Wilkerson, MD
TOBA II
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System (TOBA II).
PHASE: Follow Up (not accepting new patients)
Principal Investigator:
Steve Henao, MD, FACC, FACS
Sub-Investigators:
Richard Wilkerson, MD, RPVI
Trent Proffitt, MD
ROADSTER II
Registry is intended to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System.
PHASE: Enrolling
Principal Investigator:
Steve Henao, MD, FACC, FACS
Sub-Investigators:
Richard Wilkerson, MD, RPVI
Trent Proffitt, MD
LUCY
A prospective, consecutively enrolling, non-randomized multi center post-market registry to evaluate the Ovation ® Abdominal Stent Graft Platform when used in the endovascular treatment of female patients.
PHASE: Follow Up (not accepting new patients)
Principal Investigator:
Steve Henao, MD, FACC, FACS
Sub-Investigators:
Trent Proffitt, MD
Richard Wilkerson, MD, RPVI
IMPERIAL
To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA drug-eluting vascular stent system (ELUVIA stent) for treating superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) lesions up to 140 mm in length.
PHASE: Follow Up (not accepting new patients)
Principal Investigator:
Steve Henao, MD, FACC, FACS
Sub-Investigators:
Trent Proffitt, MD
Richard Wilkerson, MD, RPVI