Clinical trials: sponsored by Boston Scientific Corporation
In-Stent Restenosis
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in…
- Trial name
- AGENT IDE (NCT04647253)
- Testing
- AGENT DCB, PTCA balloon catheter
- Where
- 40 sites in United States
- Volunteers
- 600 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Congestive Heart Failure
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and…
- Trial name
- NECTAR-HF (NCT01385176)
- Testing
- Implant of investigational device system, Titration during the randomization phase, Titration after the randomization phase
- Where
- 21 sites in Belgium, Czechia and 6 more
- Volunteers
- 118 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
Chronic Pain
Paresthesia-Free Fast-Acting Subperception (FAST) Study
Study to evaluate the effectiveness of FAST-SCS (fast-acting paresthesia-free therapy) and additional SCS therapy options in patients with chronic pain using Boston Scientific WaveWriter SCS Systems.
- Trial name
- FAST (NCT04618471)
- Testing
- Boston Scientific WaveWriter SCS System
- Where
- 13 sites in United States
- Volunteers
- 177 people
- Sponsor
- Boston Scientific Corporation
Parkinson Disease
Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation
The objective of this study is to evaluate the performance of novel DBS programming methods compared to traditional programming methods.
- Trial name
- CLOVER (NCT03037398)
- Testing
- Vercise Deep Brain Stimulation System
- Where
- 3 sites in Germany
- Volunteers
- 69 people
- Sponsor
- Boston Scientific Corporation
ACC/AHA/NASPE Class 1, IIa or IIb Indications
Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation
The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure.
- Trial name
- NCT01117792
- Testing
- subcutaneous implantable defibrillator (S-ICD) system
- Where
- 8 sites in Italy, Netherlands and 2 more
- Volunteers
- 55 people
- Sponsor
- Boston Scientific Corporation
Aortic Stenosis
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
- Trial name
- NCT03735667
- Testing
- ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System
- Where
- 75 sites in United States, Canada
- Volunteers
- 1,948 people
- Sponsor
- Boston Scientific Corporation
Stroke
Assessment of the WATCHMAN™ Device in Patients Unsuitable for Oral Anticoagulation
The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial…
- Trial name
- ASAP-TOO (NCT02928497)
- Testing
- WATCHMAN LAAC Device Implant, Single Antiplatelet Therapy or No Therapy (Control)
- Where
- 92 sites in United States, Belgium and 7 more
- Volunteers
- 481 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)
A Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.
- Trial name
- NCT04058990
- Testing
- Device: Paclitaxel-Coated PTCA Balloon Catheter, SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel
- Where
- 14 sites in Japan
- Volunteers
- 180 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
PROMUS PREMIER™ China Post-Approval Study
To compile real-world clinical outcome data for the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System (Promus PREMIERTM Stent System) in routine clinical practice in China.
- Trial name
- NCT03273023
- Testing
- Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System
- Where
- China
- Volunteers
- 2,059 people
- Sponsor
- Boston Scientific Corporation
Gastric Outlet Obstruction
EUS-GE vs ES for Palliation of Gastric Outlet Obstruction
Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is associated with substantial morbidity.
- Trial name
- NCT03259763
- Testing
- Lumen-apposing metal stent, Self-expandable metal stent
- Where
- 9 sites in United States, Canada and 5 more
- Volunteers
- 112 people
- Sponsor
- Johns Hopkins University
Pain, Chronic
Radiofrequency (RF) Ablation Prospective Outcomes Study
The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems in the treatment of patients diagnosed with pain
- Trial name
- RAPID (NCT04673032)
- Testing
- Radiofrequency Ablation
- Where
- 15 sites in United States, Belgium and 2 more
- Volunteers
- 298 people
- Sponsor
- Boston Scientific Corporation
Arterial Occlusive Diseases, Atherosclerosis
A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries
The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions…
- Conditions
- Arterial Occlusive Diseases, Atherosclerosis, Vascular Diseases, Arteriosclerosis
- Trial name
- REGAL (NCT03037411)
- Testing
- Peripheral stenting
- Where
- 23 sites in Austria, Belgium and 3 more
- Volunteers
- 291 people
- Sponsor
- Boston Scientific Corporation
Varicose Veins
Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS)
The purpose of this study is to observe insights into the benefits of Varithena compared to Endothermal Ablation (ETA) in the treatment of the great saphenous vein.
- Trial name
- VERITAS (NCT05312970)
- Testing
- Varithena®, FDA-approved Endothermal Ablation (ETA) systems
- Where
- 9 sites in United States
- Volunteers
- 43 people
- Sponsor
- Boston Scientific Corporation
Ureter Obstruction
Double-J PLUS Postmarket Registry Study
A multi-center global registry to obtain post-market safety and efficacy data on Boston Scientific Ureteral and Urinary Diversion Stents
- Trial name
- NCT04197583
- Testing
- Boston Scientific Ureteral Stents, Urinary Diversion Stent
- Where
- 10 sites in United States, Canada and 2 more
- Volunteers
- 379 people
- Sponsor
- Boston Scientific Corporation
Paroxysmal Atrial Fibrillation
Prospective Evaluation of Open Irrigated Ablation Catheters With High Resolution Mapping to Treat Paroxysmal Atrial Fibrillation
To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines.
- Trial name
- INTERRUPT AF (NCT03729830)
- Testing
- Boston Scientific Open Irrigated Ablation Catheters
- Where
- 26 sites in United States, Germany and 4 more
- Volunteers
- 415 people
- Sponsor
- Boston Scientific Corporation
Stress Urinary Incontinence
Artificial Urinary Sphincter Clinical Outcomes
To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.
- Trial name
- AUSCO (NCT04088331)
- Testing
- AMS 800 Artificial Urinary Sphincter
- Where
- 18 sites in United States, Australia
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Stone Clearance
Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings
Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device.
- Trial name
- NCT02683993
- Testing
- Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
Persistent Atrial Fibrillation
A Prospective Single Arm Open Label Study of the FARAPULSE Pulsed Field Ablation System in Subjects With Persistent Atrial Fibrillation
The objective of the ADVANTAGE AF Study is to establish the safety and effectiveness of the FARAPULSE Pulsed Field Ablation System (FARAPULSE PFA System) for treatment of drug resistant, symptomatic persistent atrial fibrillation…
- Trial name
- ADVANTAGE AF (NCT05443594)
- Testing
- Phase 1: FARAPULSE Ablation System, Phase 2: FARAPULSE Ablation System
- Where
- 44 sites in United States, Belgium and 2 more
- Volunteers
- 669 people
- Sponsor
- Boston Scientific Corporation
Non-valvular Atrial Fibrillation (AF)
Watchman FLX Pro CT Pilot Study
The primary objective of this study is to measure device tissue coverage post-implantation of the WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device (WATCHMAN FLX Pro) using the serial advanced imaging modalities of…
- Trial name
- NCT05567172
- Testing
- Left atrial appendage closure device WM FLX Pro
- Where
- Denmark
- Volunteers
- 43 people
- Sponsor
- Boston Scientific Corporation