Device Clinical Research Trials – John Paul Runyon P.I.


The following are the research trials for which Dr. John Paul Runyon was the Principle Investigator or co-Investigator.

 

CLINICAL RESEARCH TRIALS: DEVICES

Co-Investigator
iDEV Technologies, Inc.
Comparison of the SUPERA® Peripheral System to a performance goal derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery. (The SUPERB Study). Protocol No. SFA- 1-US/EU.

Principal Investigator
Cardiva Medical Inc.
BOOMERANG Trial II: Protocol No. 2006-100 BoomerangTM ClosureWire Vascular Access Management System.D

Principal Investigator
Fox Hollow Technologies
LEAP (Phase Zero): A two-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the effect of Simvastatin, Losartan, and Pioglitazone on cardiovascular disease biomarkers in lower extremity atherosclerotic plaque excised from patients with peripheral arterial disease.

Principal Investigator
Abbott Vascular Devices
ACT I: Carotid angioplasty and stenting versus carotid endarterectomy in asymptomatic subjects who are at risk for carotid endarterectomy with significant extra-cranial carotid occlusive disease. A prospective, randomized, parallel, two-arm, multi-center trial. 3:1 ratio of CAS versus CEA.

Principal Investigator
Guidant Corporation
CAPTURE Trial: The Carotid Stent and Embolic Protections System.

Principal Investigator
Edwards LifeSciences, LLC
RESILIENT Trial: A randomized study comparing the Edwards self-expanding LifeStent vs. angioplasty- alone in lesions involving the SFA and/or proximal popliteal artery.

Co-Investigator
FoxHollow Technologies
TALON: A prospective, multicenter, observational outcomes database registry designed to collect data on the demographics, plaque excision procedures and follow-up results for patients with peripheral arterial disease.

Co-Investigator
Vascular Architects, Inc.
ASPIRE: Valiant, Vascular Architects Femoralpopliteal Sub-Optimal Angioplasty Aspire Trial.

Principal Investigator
NightHawk
A Non-Randomized study of the NightHawk Peripheral Plaque Excision System during plaque excision of peripheral arterial disease.

Principal Investigator
EASE: A prospective multicenter evaluation of the safety and effectiveness of the Phoenix AtherectomyTM System in atherectomy of the peripheral vasculature.

Principal Investigator
DEFINITIVECa++:DeterminationofthesafetyandeffectivenessoftheSilverHawkTM PeripheralPlaque Excision system for Calcium (SilverHawk LS-C) and the SpiderFXTM Ebolitic Protection Device for the treatment of calcified peripheral aterial disease in the superficial femoral and/or the popliteal arteries.

Principal Investigator
DEFINITIVE LE: Determination of effectiveness of SilverHawk Peripheral Plaque Excision (SilverHawk Device) for the treatment of infrainguinal vessels/lower extremities.

Principal Investigator
GORE VIABAHN Endoprosthesis Versus Bare Nitinol Stent in the Treatment of Long Occlusive Disease.

Co-Investigator
Second phase of carotid RX ACCULINK/RX ACCUNET post-approval trial to uncover unanticipated rare events.

Principal Investigator
AtheroMed Inc.
EASE: Prospective, multicenter clinical evaluation of the safety and effectiveness of the Phoenix AtherectomyTM System in Atherectomy of the Peripheral Vasculature.

Principal Investigator
C.R. Bard
Crosser Enters the Right Arterial Lumen (CENTRAL)

Principal Investigator
Atrium Medical Corporation
Atrium iCAST Iliac Stent Pivotal Study (ICARUS)

Co-Investigator
Boston Scientific
Boston Scientific Embolic Protection Inc. (EPI): A carotid stenting trial for high-risk surgical patients (BEACH

Principal Investigator
CABERNET: Carotid artery revascularization in high-surgical-risk patients with the NexStent and the FilterWire EX/EZ.

Co-Investigator
Gore EMPIRE clinical study to evaluate safety and efficacy of the GORE® Flow Reversal System for neuroprotection during carotid artery stenting.

Principal Investigator
Abbott Vascular
CHOICE: Carotid Stenting for High-Risk Surgical Patients.

Principal Investigator
FoxHollow
TALON Registry: Treating peripherals with SilverHawk.

Co-Investigator
Gore
GORE® Embolic Filter in carotid stenting for high-risk surgical subjects (GORE EMBOLDEN)

Principal Investigator
Boston Scientific
ORION: A Boston Scientific trial of the Epic Self-Expanding Nitinol stent in the treatment of atherosclerotic lesions in iliac arteries.

Principal Investigator
Medtronic
PIVOTAL: A randomized comparison of endovascular repair versus surveillance in patients with smaller abdominal aortic aneurysms.

Co-Investigator
National Institute of Neurological Disorders (NINDS) National Institutes of Health (NIH)
CREST: Carotid revascularization endarterectomy vs. stenting.

Co-Investigator
Abbott Vascular
ACT-1: A randomized trial to demonstrate the non-inferiority of carotid artery stenting (CAS), using the Emboshield® Embolic Protection System with the Xact® Carotid Stent System, to carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid atherosclerotic disease in subjects considered at standard risk for adverse events from CEA.

Co-Investigator
IntraLuminal Therapeutics, Inc
GRIP: Guided radio frequency in peripheral total occlusions, a 50-patient, multicenter, non-randomized registry.

Principal Investigator
FoxHollow
TALON: A prospective, multi-center, observational outcomes database registry.

Principal Investigator
FoxHollow
RED-TAIL: Registry of SFA bilateral diseases treated with the SilverHawk System. (Multi-center, prospective, outcomes database registry.)

Principal Investigator
FoxHollow
MERLIN: Multiple lesions from a unilateral extremity treated with SilverHawk in a single procedure. (Multi-center, prospective, outcomes database registry.)

Co-Investigator
Abbott Vascular Devices
EXACT: Emboshield and Xact post-approval carotid stent trial. (Multi-center, observational, single-arm, post-approval study).

Principal Investigator
FoxHollow
LEAP: A two-part, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of Simvastatin, Losartan, and Pioglizatone on cardiovascular disease biomarkers in lower extremity atherosclerotic plaque excised from patients with peripheral arterial disease.

Principal Investigator
FoxHollow
SWIFT: Femoropopliteal Disease treated with the SilverHawk Plaque Excision System: A non- randomized registry with duplex ultrasound follow-up at twelve months.

Principal Investigator
FlowMedica
PATRICIA: A Multi-Center, Randomized, Open Label Trial of Intra-renal Fenoldopam Mesylate vs. Intravenous Sodium Bicarbonate and Oral N-acetylcysteine in Patients at High Risk for Contrast Induced Neuropathy Undergoing Peripheral Vascular Intervention.

Principal Investigator
FoxHollow
BROADWING: Biological Waste MateRial and Outcomes analysis of Lower Extremity Peripheral Disease Treated with the SilverHawkTM Plaque ExcisioN System: A Tissue and Data ReGistry.

Principal Investigator
FoxHollow Technologies, Inc.
NIGHTHAWK: Evaluation of the NightHawk peripheral excision system for patients with infrainguinal lesions. (20-patient, non-randomized, multi-center trial).

Principal Investigator
EV3
DEFINITIVE CA++: SilverHawk LS-C with SpiderFX in lower extremity PAD undergoing plaque excision (102-patient, prospective, multi-center, non-randomized, single-arm study).

Principal Investigator
Idev Technologies, Inc.
SUPERB-SUPERA: Nitinol Stent System in treating subjects with obstructive SFA disease. (258-patient prospective, multi-center, non-randomized, single-arm trial).

Co-Investigator
Abbott Vascular
CHOICE: Carotid Stenting for High-Risk Patients: Evaluating Outcomes Through Collection of Clinical Evidence. (Open-ended enrollment, non-randomized, multi-center trial).

Co-Investigator
Abbott Vascular
ACT I: Carotid Angioplasty and stenting versus endarterectomy in asymptomatic subjects with significant extracranial carotid occlusive diseases (1,540-patient, multi-center, randomized trial).

Co-Investigator
Lutonix Inc.
LEVANT 2: MoxyTM drug-coated balloon vs. standard balloon angioplasty for treatment of femoropopliteal arteries (500-patient, prospective, multi-center, single-blind, randomized trial).

Co-Investigator
ANTRIN: Photoangioplasty for human peripheral atherosclerosis, a Phase 1 trial of photodynamic therapy with motexafin lutetium (Antrin).

Principal Investigator
MOBILE: A randomized study for the treatment of in-stent restenosis in SFA lesions using the Corona system.

Principal Investigator
CSI
OASIS: A prospective, non-randomized, multi-center trial to assess the safety and short-term efficacy of orbital atherectomy for chronic infrapopliteal arterial occlusive disease.

Principal Investigator
IDev Technologies
SUPERB: Comparison of the SUpera® PERipheral System to a performance goal derived from balloon angioplasty clinical trials in the superficial femoral artery.

Principal Investigator
NIH
CORAL: Cardiovascular Outcomes in Renal Atherosclerotic Lesions. A study to compare medical therapy plus stenting of hemodynamically significant renal artery stenosis versus medical therapy alone in patients with systolic hypertension and renal artery stenosis.

Co-Investigator
Abraxis BioScience Inc.
ABRAXANE: Phase II, randomized, open-label, prospective, multicenter study trial to evaluate the efficacy and safety of three different dosing schedules of CoroxaneTM for the prevention and reduction of restenosis following revascularization of the superficial femoral artery (SFA).