Clinical Research Trials with Dr. John Paul Runyon as P.I.
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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.
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.
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.
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.
CAPTURE Trial: The Carotid Stent and Embolic Protections System.
RESILIENT Trial: A randomized study comparing the Edwards self-expanding LifeStent vs. angioplasty- alone in lesions involving the SFA and/or proximal popliteal artery.
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.
ASPIRE: Valiant, Vascular Architects Femoralpopliteal Sub-Optimal Angioplasty Aspire Trial.
A Non-Randomized study of the NightHawk Peripheral Plaque Excision System during plaque excision of peripheral arterial disease.
EASE: A prospective multicenter evaluation of the safety and effectiveness of the Phoenix AtherectomyTM System in atherectomy of the peripheral vasculature.
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.
DEFINITIVE LE: Determination of effectiveness of SilverHawk Peripheral Plaque Excision (SilverHawk Device) for the treatment of infrainguinal vessels/lower extremities.
GORE VIABAHN Endoprosthesis Versus Bare Nitinol Stent in the Treatment of Long Occlusive Disease.
Second phase of carotid RX ACCULINK/RX ACCUNET post-approval trial to uncover unanticipated rare events.
EASE: Prospective, multicenter clinical evaluation of the safety and effectiveness of the Phoenix AtherectomyTM System in Atherectomy of the Peripheral Vasculature.
CABERNET: Carotid artery revascularization in high-surgical-risk patients with the NexStent and the FilterWire EX/EZ.
Gore EMPIRE clinical study to evaluate safety and efficacy of the GORE® Flow Reversal System for neuroprotection during carotid artery stenting.
CHOICE: Carotid Stenting for High-Risk Surgical Patients.
TALON Registry: Treating peripherals with SilverHawk.
ORION: A Boston Scientific trial of the Epic Self-Expanding Nitinol stent in the treatment of atherosclerotic lesions in iliac arteries.
PIVOTAL: A randomized comparison of endovascular repair versus surveillance in patients with smaller abdominal aortic aneurysms.
CREST: Carotid revascularization endarterectomy vs. stenting.
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.
GRIP: Guided radio frequency in peripheral total occlusions, a 50-patient, multicenter, non-randomized registry.
TALON: A prospective, multi-center, observational outcomes database registry.
EXACT: Emboshield and Xact post-approval carotid stent trial. (Multi-center, observational, single-arm, post-approval study).
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.
SWIFT: Femoropopliteal Disease treated with the SilverHawk Plaque Excision System: A non- randomized registry with duplex ultrasound follow-up at twelve months.
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.
BROADWING: Biological Waste MateRial and Outcomes analysis of Lower Extremity Peripheral Disease Treated with the SilverHawkTM Plaque ExcisioN System: A Tissue and Data ReGistry.
NIGHTHAWK: Evaluation of the NightHawk peripheral excision system for patients with infrainguinal lesions. (20-patient, non-randomized, multi-center trial).
DEFINITIVE CA++: SilverHawk LS-C with SpiderFX in lower extremity PAD undergoing plaque excision (102-patient, prospective, multi-center, non-randomized, single-arm study).
SUPERB-SUPERA: Nitinol Stent System in treating subjects with obstructive SFA disease. (258-patient prospective, multi-center, non-randomized, single-arm trial).
CHOICE: Carotid Stenting for High-Risk Patients: Evaluating Outcomes Through Collection of Clinical Evidence. (Open-ended enrollment, non-randomized, multi-center trial).
ACT I: Carotid Angioplasty and stenting versus endarterectomy in asymptomatic subjects with significant extracranial carotid occlusive diseases (1,540-patient, multi-center, randomized trial).
LEVANT 2: MoxyTM drug-coated balloon vs. standard balloon angioplasty for treatment of femoropopliteal arteries (500-patient, prospective, multi-center, single-blind, randomized trial).
ANTRIN: Photoangioplasty for human peripheral atherosclerosis, a Phase 1 trial of photodynamic therapy with motexafin lutetium (Antrin).
MOBILE: A randomized study for the treatment of in-stent restenosis in SFA lesions using the Corona system.
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.
SUPERB: Comparison of the SUpera® PERipheral System to a performance goal derived from balloon angioplasty clinical trials in the superficial femoral artery.
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.
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).