Clinical trials: Stent Stenosis
Carotid Artery Stenosis
GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
Compare the 30-day safety and efficacy of the GORE® Embolic Filter used in conjunction with FDA-approved carotid stents to a performance goal obtained from carotid stent studies utilizing distal embolic protection.
- Trial name
- EMBOLDEN (NCT00766493)
- Testing
- GORE® Embolic Filter
- Volunteers
- 250 people
- Sponsor
- W.L.Gore & Associates
Graft Occlusion, Vascular, Coronary Restenosis
A Blinded Study Conducted at Multiple Centers Evaluating Various Doses of an Investigational Agent (BO-653) Against Placebo, for Safety and Effectiveness in Preventing Post-Angioplasty Blood Vessel Re-Closure (Restenosis) in Stented Vessels.
This research study is intended to evaluate the safety and effectiveness of 3 different doses of BO-653, an investigational inhibitor of LDL cholesterol oxidation, when given orally twice a day compared to placebo (an inactive…
- Conditions
- Graft Occlusion, Vascular, Coronary Restenosis, Atherosclerosis
- Trial name
- NCT00055510
- Testing
- BO-653
- Where
- 29 sites in United States
- Sponsor
- Chugai Pharma USA
Chronic Coronary Occlusion, Vascular Disease
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)
XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and To…
- Conditions
- Chronic Coronary Occlusion, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Trial name
- XVU-LTF (NCT01120379)
- Testing
- XIENCE V® EECSS
- Where
- United States
- Volunteers
- 5,034 people
- Sponsor
- Abbott Medical Devices
Chronic Total Occlusion of Coronary Artery, Vascular Disease
XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives of this study are To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and To…
- Conditions
- Chronic Total Occlusion of Coronary Artery, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Trial name
- XVU-AV DAPT (NCT01106534)
- Testing
- clopidogrel + aspirin OR prasugrel + aspirin, XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
- Where
- 144 sites in United States
- Volunteers
- 870 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Stent Restenosis
A Phase 1b Study Evaluating RESTEN-MP in Subjects With Focal de Novo Stenosis
The process of re-narrowing of a coronary artery following a revascularization procedure such as angioplasty, begins at the time of the procedure.
- Trial name
- NCT00244647
- Testing
- RESTEN-MP
- Volunteers
- 40 people
- Sponsor
- Sarepta Therapeutics, Inc.
Peripheral Arterial Disease (PAD)
Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses
This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.
- Trial name
- XPEDITE (NCT02936622)
- Testing
- Zilver® Paclitaxel-Eluting Peripheral Stent, Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating, Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating
- Where
- 11 sites in Germany, New Zealand
- Volunteers
- 176 people
- Sponsor
- Cook Group Incorporated
Carotid Stenosis, Carotid Artery Diseases
Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)
The PERFORMANCE III study is a prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP® Direct System for the treatment of carotid artery stenosis in subjects at…
- Trial name
- NCT05845710
- Testing
- Neuroguard IEP Direct System
- Where
- 32 sites in United States, France
- Volunteers
- 178 people
- Sponsor
- Contego Medical, Inc.
Left Main Coronary Artery Stenosis
eTryton Left Main Registry Tryton Side Branch Stent® Tmt of Denovo CAD in LM and CFX Arteries
The objective of this study is to demonstrate the clinical performance of the Tryton Side Branch Stent used in conjunction with a commercially available Drug Eluting Stent (DES) to treat de novo bifurcated lesions involving both…
- Trial name
- eTRYTONLM (NCT02765646)
- Testing
- Coronary stent procedure (CSP)
- Where
- Germany
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Tryton Medical, Inc.
Chronic Pancreatitis
WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures
To prospectively document the performance of a FCSEMS for treatment of pancreatic duct strictures in patients with painful chronic pancreatitis.
- Trial name
- NCT02802020
- Testing
- Pancreatic fully-covered self-expanding metal stent (FCSEMS)
- Where
- 11 sites in United States, Belgium and 4 more
- Volunteers
- 67 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease (CAD), Chronic Total Occlusion (CTO)
EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions
A prospective, multi-center, single-arm study to establish the safety and effectiveness of the XIENCE V® Everolimus Eluting Coronary Stent, XIENCE nano™ Everolimus Eluting Coronary Stent, XIENCE PRIME™ LL Everolimus Eluting…
- Trial name
- EXPERT CTO (NCT01435031)
- Testing
- CTO Treatment Device
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Abbott Medical Devices
Biliary Strictures Caused by Malignant Neoplasms
Study of the WallFlex™ Biliary Partially-covered Stent for the Palliative Treatment of Malignant Bile Duct Obstruction
This is a a prospective study of the WallFlex™ Biliary Partially-covered Stent designed to collect data to support regulatory clearance by the FDA in the United States and to determine the functionality of the WallFlex™ Biliary…
- Trial name
- NCT00713427
- Testing
- WallFlex™ Biliary Partially-Covered Stent
- Where
- 6 sites in Belgium, France and 4 more
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
Carotid Artery Stenosis
GORE Embolic Protection With Reverse Flow
To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.
- Trial name
- EMPiRE (NCT00594100)
- Testing
- GORE Flow Reversal System (GFRS)
- Where
- 2 sites in United States
- Volunteers
- 245 people
- Sponsor
- W.L.Gore & Associates
Ischemic Stroke, Transient Ischemic Attack
AcoArt VI / Vertebral Artery Ostium Stenosis in China
The purpose of this study is to determine whether DEB is not inferior to common bare metal stent using under in long-term vessel patency and inhibiting restenosis in Vertebral Artery Ostium Stenosis
- Trial name
- NCT03910166
- Testing
- drug-coated balloon catheter（Orchid, Acotec）, Intracranial artery stent system（APOLLO）
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Acotec Scientific Co., Ltd
Acute Myocardial Infarction, Restenoses, Coronary
Abbott Vascular Medical Device Registry
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use…
- Conditions
- Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism
- Trial name
- AV-MDR (NCT04573660)
- Testing
- Coronary and peripheral stents, Pacing catheters, Vascular plugs
- Where
- 37 sites in United States, Australia and 12 more
- Volunteers
- 3,784 people
- Sponsor
- Abbott Medical Devices
Carotid Artery Diseases
A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach
The objective of this study is to evaluate acute device and technical success of the CGuard Prime™ Carotid Stent System (80cm) when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures…
- Trial name
- NCT06653387
- Testing
- CGuard Prime 80cm stent system
- Where
- 8 sites in United States
- Volunteers
- 50 people
- Sponsor
- InspireMD
Iliac Artery Stenosis
EPIC Nitinol Stent System in the Treatment of Atherosclerotic Lesions in Iliac Arteries
The ORION study is being conducted to determine whether the Epic™ Nitinol Stent for primary stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.
- Trial name
- ORION (NCT00896337)
- Testing
- Epic™ Nitinol Stent System, Anti-platelet therapy, Anti-coagulation therapy
- Where
- 28 sites in United States
- Volunteers
- 125 people
- Sponsor
- Boston Scientific Corporation
Carotid Artery Stenosis
CGUARDIANS III IDE Pivotal Trial
This is a prospective, multi-center, single-arm, pivotal study. The objective of this study is to evaluate the safety and efficacy of the SwitchGuard NPS in providing cerebral embolic protection during Transcarotid Artery…
- Trial name
- NCT07277296
- Testing
- SwitchGuardTM NPS
- Volunteers
- 103 people
- Sponsor
- InspireMD
Pulmonary Artery Stenosis, Aortic Coarctation
Minima Stent System Post- Approval Study (PAS)
This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States.
- Trial name
- NCT06828770
- Testing
- Minima Stent System
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- Renata Medical
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
The goal of this clinical trial is to learn if the SiroMax™ drug-coated balloon catheter is safe and works to treat stenotic coronary lesions in adults.
- Conditions
- Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), In-Stent Restenosis or De Novo Coronary Artery Lesions, In-Stent Stenosis (Restenosis) of Coronary Artery Stent
- Trial name
- SMART-I (NCT07811024)
- Testing
- Sirolimus-coated balloon catheter
- Where
- 2 sites in Uzbekistan
- Volunteers
- 60 people
- Sponsor
- Tonic Medical, Inc.
Coronary Artery Disease
Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions
The purpose of the this trial is to evaluate the clinical safety and efficacy of Cilostazol eluting stent system (CES-1) for the treatment of single de novo lesions in native coronary arteries.
- Trial name
- NCT03189641
- Testing
- Cilostazol eluting stent system (CES-1)
- Where
- 6 sites in Japan
- Volunteers
- 30 people
- Sponsor
- JIMRO Co., Ltd.