NCT04246463
WL Gore
ARISE II
February 2024
Co-PI
Status: Enrolling
Post Market registry collecting real world, post-approval safety, performance, patient reported outcomes and health economic data on patients treated with Terumo Aortic endovascular stent-grafts in standard clinical practice.
NCT05365490
Silkroad Medical
ROADSTER 3
May 2023
Principal Investigator
Status: Enrolling
This is an open label, single arm, multi-center post-approval study for the treatment of patients at standard risk for adverse events from carotid endarterectomy who require carotid revascularization and who are eligible for treatment using the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid Neuroprotection System. The study will enroll a maximum of 400 patients treated per protocol at 30-60 sites in the United States.
NCT03477604
Micro Medical
STAND
January 2021
Principal Investigator
Status: Enrolling
Randomized multicenter clinical trial consisting of two arms; one arm treated with PTA plus the MicroStent® System and one arm treated with PTA alone. Purpose to evaluate the safety and effectiveness of using the MicroStent® Peripheral Vascular Stent System, hereafter referred to as the MicroStent® System, for the treatment of infrapopliteal lesions in subjects with peripheral arterial disease.
NCT05007925
Shockwave Medical
PAD BTK II
January 2021
Principal Investigator
Status: Enrolling
To assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic BTK arteries. Post-market, prospective , multi-center, single-arm study.
NCT03985774
Silk Road Medical
January 2021
Principal Investigator
Status: SIV
The ENROUTE Transcarotid NPS has received CE Mark and is commercially available in the European Union. The ENROUTE Transcarotid NPS may be used in conjunction with carotid artery stent approved for revascularization in patients with carotid disease in the context of this study.This is a prospective, single-arm, multi-center clinical trial of the ENROUTE Transcarotid NPS in conjunction with all commercially approved carotid artery stents used for revascularization in patients with carotid disease.The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions (relative to baseline) and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure.
NCT04246463
Terumo Aortic
TREO Registry
December 2020
Principal Investigator
Status: Actively Recruiting
Post Market registry collecting real world, post-approval safety, performance, patient reported outcomes and health economic data on patients treated with Terumo Aortic endovascular stent-grafts in standard clinical practice.
NCT03033043
Terumo Aortic
RELAY PRO-D
November 2020
Investigator
Status: Actively Recruiting
This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure.
NCT04244370
C.R. Bard
MONARCH Registry
April 2020
Principal Investigator
Status: Actively Enrolling
The primary objective of this study is to evaluate the performance and safety of the Caterpillar™ Arterial Embolization Device when used for arterial embolization in the peripheral vasculature in a real world, on-label application.
NCT03756558
Terumo Medical Corporation
CROSS-SEAL IDE
August 2019
National Principal Investigator
Status: Actively Recruiting
The Cross-Seal device is a VCD intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (8‐18F ID) interventional devices. The function of Cross-Seal is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure. The study is being conducted to demonstrate the safety and effectiveness of Cross-Seal in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.
NCT03193619
C.R. Bard
ULTRASCORE
January 2019
Principal Investigator
Status: Actively Enrolling
The registry is a prospective, multi-center, single-arm, real-world study to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon for the treatment of stenotic lesions of the superficial femoral artery (SFA), popliteal artery, and infra-popliteal arteries (posterior tibial, anterior tibial and peroneal arteries). Follow-up for all treated subjects will be performed at hospital discharge, 30 days, and 6 and 12 months post-index procedure.
NCT03635190
August 2019
Cardio Flow, Inc
Principal Investigator
Status: Actively Recruiting
To evaluate the safety and effectiveness of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System for atherosclerotic plaque removal and vessel compliance modification in de novo native target lesions in the peripheral vasculature of the lower extremities.
NCT02528500
W.L. Gore and Associates
GORE TAMBE Study
March 2018
Principle Investigator
Status: Actively Recruiting
This is a prospective, non-randomized study designed to assess the feasibility of the TAMBE Device in the treatment of patients with aortic aneurysms involving the visceral branch vessels. A maximum of 10 Subjects will be treated under this Protocol. This clinical study will include up to six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams, contrast-enhanced computed tomography (CT) of chest, abdomen and pelvis, creatinine measurement, abdominal ultrasound (optional) at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis implant.
NCT01534819
Medtronic Endovascular
February 2018
Principal Investigator
Status: Closed
Placement of the Aptus Heli-FX™ EndoAnchor System in subjects for the prevention of graft migration and the treatment of Type Ia endoleak or Aptus Heli-FX EndoAnchor System placed at the time of initial endograft implantation, either to prevent endograft migration and Type Ia endoleak, or to treat Type Ia endoleak evident at the time of implantation.
NCT02777593
W.L. Gore and Associates
GORE TAG TBE Study
February 2017
Co-Investigator
Status: Recruitment Pause
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta
NCT0253637
Silk Road Medical
ROADSTER 2 Registry
Principal Investigator
November 2015
Principle Investigator
Status: Closed
The ROADSTER 2 Registry is intended to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience transcarotid technique.
NCT02414841
July 2015
Co-Investigator
Status: Closed
This research study is designed to assess the safety and effectiveness of an experimental drug called vonapanitase (PRT-201) in patients who have chronic kidney disease and who are undergoing surgery to create a new access point to their bloodstream for hemodialysis.
NCT02393716
Medtronic Medical
ENDURANT EVO
June 2015
Co-Investigator
Status: Closed
The purpose of this study is to demonstrate that the Endurant Evo AAA stent graft system is safe and effective for endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms
NCT02089217
National Institutes of Health
CREST 2 Study
February 2015
Principal Investigator
Status: Closed
Carotid revascularization for primary prevention of stroke (CREST-2) in two multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting.
NCT02240862
National Institutes of Health
The CREST-2 Companion Registry (C2R)
February 2015
Principal Investigator
Status: Closed
The objective of the CREST-2 Registry is to promote the rapid initiation and completion of enrollment in the CREST-2 randomized clinical trial (clinicaltrials.gov ID NCT02089217). results from the CREST-2 randomized clinical trial.
NCT01855412
Cardiovascular Systems
Observational Study to Evaluate PAD Treatment Clinical and Economic Outcomes LIBERTY
April 2015
Principal Investigator
Status: Closed
The purpose of this study is to evaluate acute and long-term clinical and economic outcomes of endovascular procedures to treat Peripheral Arterial Disease (PAD).
NCT01658787
W.L. Gore and Associates GREAT Outcomes Evaluation June 2014
Co-Investigator
Status: Closed
This is a prospective observational cohort Registry designed to obtain data on device performance and clinical outcomes of patients treated with Gore endovascular aortic products.
NCT01904851
Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes XLPAD
The University of Texas Southwestern July 2014
Principal Investigator
Status: Actively Recruiting
XLPAD is an observational study designed to evaluate the effectiveness and use of stent and non-stent based therapies among PAD patients. The study will create a registry that will include entry of procedural and clinical follow-up information into an online data collection software, REDCAP.
Outcomes Study for Thoracic Aortic Dissection Treatment with Thoracic Endograft Society of Vascular Surgeons
August 2014
Principal Investigator
Status: Closed
The purpose of this study is to evaluate outcomes of thoracic endografts in the treatment of sub-acute and chronic Type B thoracic aortic dissection
NCT01685567
Silk Road Medical
Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure
ROADSTER
June 2013
Principal Investigator
Status: Closed
The purpose of this study is to evaluate the safety and effectiveness of the MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) in providing cerebral embolic protection during carotid artery stenting. It will be used in conjunction with a FDA approved carotid artery stent for the treatment of carotid artery disease.
NCT01970007
Cook Medical
VIVO Clinical Study
June 2013
Co-Investigator
Status: Closed
The purpose of the VIVO Clinical Study is to evaluate the safety and effectiveness of the Zilver® Vena™ Venous Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.