Clinical trials: sponsored by Boston Scientific Corporation
Coronary Artery Disease
Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions
This study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).
- Trial name
- LARGER-DCB (NCT06954714)
- Testing
- Drug-eluting stent implantation, Drug-coated balloon angioplasty
- Where
- 8 sites in South Korea
- Volunteers
- 256 people
- Sponsor
- Chonnam National University Hospital
Atrial Arrhythmia, Intracardiac Echocardiography
A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure
A first-in-human prospective data collection study including subjects who are planned to undergo an ablation procedure for any atrial arrhythmia as per medical judgement and the site's standard practice, represents the most…
- Trial name
- SONAR-ICE (NCT07353710)
- Testing
- ICE Image Acquisition
- Where
- 8 sites in Australia, Croatia and 6 more
- Volunteers
- 200 people
- Sponsor
- Boston Scientific Corporation
Liver Neoplasms
TheraSphere Japan Pre-Market Study
To investigate the safety and effectiveness of BSJ019T in Japanese patients with primary or secondary liver who are not candidate for standard treatment.
- Trial name
- INDIGO (NCT07377487)
- Testing
- TheraSphere Y-90 glass microsphere
- Where
- 5 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Boston Scientific Corporation
Extracranial Carotid Artery Disease, TCAR
Real-World Treatment of Extracranial Carotid Artery Disease With the ENROUTE™ Transcarotid Neuroprotection System
The ENTRUST registry's objective is to collect real-world data (RWD) and health economic data on the ENROUTE™ Transcarotid Neuroprotection System (ENROUTE™ Transcarotid NPS), including populations in which outcomes of…
- Conditions
- Extracranial Carotid Artery Disease, TCAR, Transcarotid Artery Revascularization
- Trial name
- ENTRUST (NCT07455747)
- Testing
- Use of ENROUTE™ Transcarotid Neuroprotection System in conjunction with any commercially available Boston Scientific stent marketed for treatment of carotid artery disease
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- Boston Scientific Corporation
Coronary Arterial Disease (CAD), de Novo Lesions in Native Coronary Arteries
AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions
AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care…
- Trial name
- NCT06959524
- Testing
- Drug Eluting Balloon, Drug eluting stent, Plain old balloon angioplasty
- Where
- 71 sites in United States, Australia and 7 more
- Volunteers
- 1,616 people
- Sponsor
- Boston Scientific Corporation
Benign Prostate Obstruction (BPO)
SteamOne - Prospective Database for Rezum Water Vapor Therapy of the Prostate
This study is to assess the clinical data of Rezum (water vapor therapy) in patients with BPO (benign prostate obstruction) and male LUTS (lower urinary tract symptoms) in terms of efficacy, durability and safety in a large…
- Trial name
- SteamOne (NCT05495633)
- Testing
- Collection and evaluation of clinical (CROMs) and patient-reported outcomes (PROMs), Analysis of uroflowmetry data by EmanoFlow Mobile Application (App) and Emano Clinic Portal
- Where
- 19 sites in Austria, Germany and 1 more
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Basel, Switzerland
Malignant Biliary Stenosis
Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis
The study is designed to highlight the effectiveness of the Hot AXIOS™ stent when used in accordance with standard medical practice on the evolution of the quality of life of patients with malignant biliary stenosis requiring…
- Trial name
- RAINBOW (NCT06750146)
- Testing
- Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System
- Where
- 18 sites in France
- Volunteers
- 162 people
- Sponsor
- Boston Scientific Corporation
Anastomotic Leaks
Study of Eso-SPONGE for Treating Leaks After Upper Gastrointestinal Surgery
To evaluate the safety and effectiveness of sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE for the treatment of anastomotic leaks in the upper gastrointestinal tract in a prospective multi-center study.
- Trial name
- DRAIN Upper (NCT07711093)
- Testing
- sponge-based Endoscopic Vacuum Therapy (EVT) using Eso-SPONGE
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF), Stroke
Elite AF IDE Trial (Elite AF)
The primary objective of this study is to establish the safety and effectiveness of the WATCHMAN Elite Left Atrial Appendage Closure (LAAC) Device for subjects with non-valvular atrial fibrillation who are eligible for…
- Trial name
- NCT07287436
- Testing
- WATCHMAN Elite LAAC Device
- Where
- 2 sites in United States
- Volunteers
- 400 people
- Sponsor
- Boston Scientific Corporation
Peripheral Vascular Diseases
Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature
The ELEGANCE Registry's objective is to collect Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of…
- Trial name
- ELEGANCE (NCT04674969)
- Testing
- Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.
- Where
- 86 sites in United States, Australia and 10 more
- Volunteers
- 5,000 people
- Sponsor
- Boston Scientific Corporation
Tachycardia, Ventricular, Arrhythmia, Ventricular
Effectiveness of the EMPOWER™ Modular Pacing System and EMBLEM™ Subcutaneous ICD to Communicate Antitachycardia Pacing
The MODULAR ATP Clinical Study is designed to demonstrate safety, performance, and effectiveness of the Modular Cardiac Rhythm Management (mCRM) Therapy System.
- Trial name
- MODULAR ATP (NCT04798768)
- Testing
- mCRM Therapy System
- Where
- 38 sites in United States, Austria and 7 more
- Volunteers
- 297 people
- Sponsor
- Boston Scientific Corporation
Respiration Rate Detection
Respiration Measured Via End-tidal CO2 and Spirometry Study (RESPI)
To collect respiration data via end-tidal CO2 and spirometry and compare respiration rates measured via the two methods.
- Trial name
- RESPI (NCT07537478)
- Testing
- Wearable Respiration mask - exercise, Wearable respiration Mask
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Stroke
CHAMPION-AF Clinical Trial
The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial…
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- CHAMPION-AF (NCT04394546)
- Testing
- WATCHMAN FLX LAAC Device, Non-Vitamin K Oral Anticoagulant
- Where
- 141 sites in United States, Australia and 14 more
- Volunteers
- 3,000 people
- Sponsor
- Boston Scientific Corporation
Orthostatic Hypotension, Reflex Syncope
Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
To characterize the impact of orthostatic hypotension (OH) and Vasovagal syncope on signals measured using a wearable Holter monitor in the clinic and ambulatory setting.
- Trial name
- ARISE (NCT07502599)
- Testing
- Wearable holter monitor
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation (AF)
Prospective Remapping With Concomitant Left Atrial Appendage Occlusion to Ensure Durable Electroporation Study
This is a single-arm, open label, clinical outcome study to research the durability (success) of receiving a pulsed field ablation (PFA) per standard of care for treatment of atrial fibrillation during a subsequent procedure for…
- Trial name
- PRECLUDE (NCT07620262)
- Testing
- Remapping Procedure
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Northwell Health
Erectile Dysfunction
IT Matters: The Erectile Restoration Registry
The objective of the It MATTERS registry is to collect Real-World Data (RWD) to monitor the safe and effective use of commercially available Boston Scientific Corporation (BSC) penile prostheses
- Trial name
- NCT04200937
- Testing
- Tactra Malleable, Spectra™ Concealable Penile Prothesis, AMS Ambicor™ Inflatable Penile Prosthesis
- Where
- 25 sites in United States, China and 1 more
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Chronic Pain, Intractable Pain
Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control
Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU).
- Conditions
- Chronic Pain, Intractable Pain, Low Back Pain, Chronic Low-back Pain
- Trial name
- MOSAIC (NCT07190807)
- Testing
- Boston Scientific WaveWriter Alpha™ SCS Systems
- Where
- 7 sites in United States
- Volunteers
- 70 people
- Sponsor
- Boston Scientific Corporation
Benign Prostatic Hyperplasia (BPH)
REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men
The study objective is to compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men.
- Trial name
- VAPEUR (NCT04838769)
- Testing
- REZŪM, alpha blocker and 5-alpha reductase inhibitor
- Where
- 21 sites in Australia, France
- Volunteers
- 155 people
- Sponsor
- Boston Scientific Corporation
Prostate Cancer
Effectiveness of the SpaceOAR Vue System in Subjects With Prostate Cancer
To demonstrate the effectiveness of the SpaceOAR Vue System in reducing late gastrointestinal (GI) toxicity in subjects undergoing Stereotactic Body Radiotherapy (SBRT) to treat prostate cancer.
- Trial name
- SABRE (NCT04905069)
- Testing
- SpaceOAR Vue System
- Where
- 30 sites in United States, Australia and 7 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation, Stroke
SIMPLAAFY Clinical Trial
The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- SIMPLAAFY (NCT06521463)
- Testing
- WATCHMAN FLX Pro LAAC Device
- Where
- 86 sites in United States
- Volunteers
- 1,857 people
- Sponsor
- Boston Scientific Corporation