Clinical trials: All Comers
Coronary Artery Diseases
BIOFLOW-III UK Satellite Registry Orsiro Stent System
Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). 500 subjects will be enrolled in this registry.
- Trial name
- NCT02257710
- Testing
- Orsiro
- Where
- 4 sites in United Kingdom
- Volunteers
- 500 people
- Sponsor
- Biotronik UK Ltd.
Calcific Coronary Arteriosclerosis
Prospective Registry on Intravascular Lithotripsy
multicenter, international, all-comers registry aims to provide insights in the current application of IVL technology in patients with calcified coronary lesions undergoing PCI using IVL technology.
- Trial name
- BENELUX-IVL (NCT06577038)
- Testing
- PCI with use of IVL
- Where
- 8 sites in Belgium, Greece and 1 more
- Volunteers
- 1,000 people
- Sponsor
- Leiden University Medical Center
Aortic Stenosis
TAVR Without Predilatation
The procedure is performed via transfemoral or transcaprotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon…
- Trial name
- TAVIWOP (NCT04350658)
- Testing
- Transcatheter aortic valve implantation required for symptomatic aortic stenosis
- Where
- France
- Volunteers
- 138 people
- Sponsor
- University Hospital, Montpellier
Coronary Heart Disease, Angioplasty, Balloon
The Clinical Efficacy and Safety of Drug-coated Balloon
Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated on the balloon.
- Trial name
- NCT05133921
- Where
- China
- Volunteers
- 2,487 people
- Sponsor
- Xijing Hospital
Retinal Disease, Electroretinogram
RETeval All Comers Trial (REACT)
The primary objective of this study is to collect electroretinogram ERG measurements from visually normal and abnormal subjects using the FDA cleared RETeval device (K142567).
- Trial name
- REACT (NCT03065881)
- Testing
- RETeval
- Where
- United States
- Volunteers
- 664 people, healthy volunteers welcome
- Sponsor
- LKC Technologies, Inc.
Coronary Artery Disease
BioFreedom Ultra Registry
Over the past three decades, coronary stent struts have been made progressively thinner. Thin strut drug-eluting stents (DES) performed better than their thicker counterparts in a recent study.
- Trial name
- NCT05094284
- Testing
- BioFreedom Ultra
- Where
- Hong Kong
- Volunteers
- 300 people
- Sponsor
- Chinese University of Hong Kong
Coronary Artery Diseases
BIOTRONIK - BIOFLOW-III Registry French Satellite
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success.
- Trial name
- NCT02273648
- Testing
- Drug Eluting Stent (DES)
- Where
- 50 sites in France
- Volunteers
- 1,000 people
- Sponsor
- Biotronik France
Coronary Stenosis
Study Comparing the MiStent SES Versus the XIENCE EES Stent
The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease.
- Trial name
- DESSOLVE III (NCT02385279)
- Testing
- MiStent, XIENCE EES
- Where
- 20 sites in France, Germany and 2 more
- Volunteers
- 1,398 people
- Sponsor
- ECRI bv
Coronary Artery Disease, Myocardial Ischemia
Genoss DES Prospective Multicenter Registry
This registry is a clinical post-market evaluation of the Genoss DES in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction
- Trial name
- NCT03045913
- Testing
- Genoss DES
- Where
- 17 sites in South Korea
- Volunteers
- 2,000 people
- Sponsor
- Young Jin Youn, MD, PhD
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Romania Satellite Registry
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Trial name
- NCT01593059
- Where
- 4 sites in Romania
- Volunteers
- 13 people
- Sponsor
- Biotronik Vertriebs-GmbH
Coronary Artery Disease
Everolimus- Versus Biolimus-Eluting Stents in All-Comers
This study sought to investigate safety and efficacy of biolimus-eluting stents (BES) with biodegradable polymer as compared with everolimus-eluting stents (EES) with durable polymer through 3 years of follow-up.
- Trial name
- EverBio (NCT01472705)
- Where
- Switzerland
- Volunteers
- 814 people
- Sponsor
- University of Freiburg
Peripheral Arterial Disease, Diabetes Mellitus
Comparing BlueDop Vascular Expert to Ankle-Brachial Index in the Identification of Peripheral Vascular Disease
To compare the screening capabilities of the BlueDop Vascular Expert (BVE) and ankle brachial index (ABI) in peripheral arterial disease for all-comer patients and those with diagnosed diabetes mellitus.
- Trial name
- NCT06436001
- Where
- United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Dakota Vascular
Coronary Artery Disease, Angina Pectoris
DUrable Polymer-based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity
Rationale: The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on DES performance.
- Conditions
- Coronary Artery Disease, Angina Pectoris, Unstable Angina Pectoris, Acute Coronary Syndrome
- Trial name
- DUTCHPEERS (NCT02175706)
- Testing
- Resolute Integrity®, Promus Element®
- Where
- 4 sites in Netherlands
- Volunteers
- 1,811 people
- Sponsor
- Thorax Centrum Twente
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry
The BIOFLOW-VIII registry is a post-market clinical evaluation of the Orsiro Mission stent in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Trial name
- BIOFLOW-VIII (NCT04555174)
- Testing
- Orsiro Mission DES
- Where
- 41 sites in France
- Volunteers
- 872 people
- Sponsor
- Biotronik AG
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
Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation
CoreValve™ Evolut R™ 34 mm System Registry (CoreValve34)
With the introduction of the CoreValve™ Evolut R™ 34mm (Medtronic™) prosthesis, patients with severe symptomatic aortic stenosis (AS) and large aortic annulus have become eligible for transcatheter aortic valve implantation…
- Trial name
- TAVI34mm (NCT03621709)
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Fundacin Biomedica Galicia Sur
Peripheral Artery Disease
Acotec DCB Post Market Clinical Follow-up
All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical…
- Trial name
- FLOWER (NCT04393389)
- Testing
- AcoArt Orchid (0.035"), AcoArt Tulip (0.018") and AcoArt Litos (0.014") percutaneous transluminal angioplasty (PTA) paclitaxel drug coated balloon catheter manufactured by Acotec Scientific Co., Ltd.
- Where
- 7 sites in Germany
- Volunteers
- 3,000 people
- Sponsor
- Acotec Scientific Co., Ltd
Ventral Hernia, Incisional Hernia
A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair
Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.
- Trial name
- NCT02053168
- Testing
- Resorbable Mesh
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- C. R. Bard
Peripheral Arterial Occlusive Disease
Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW)
The aim of the study is to assess the safety and efficacy of the paclitaxel-releasing balloon catheter SeQuent® Please OTW to treat de novo and restenotic lesions in peripheral arteries.
- Trial name
- CONSEQUENT (NCT02460042)
- Testing
- drug coated balloon angioplasty, SeQuent® Please OTW Paclitaxel Coated Balloon Catheter
- Where
- Germany
- Volunteers
- 960 people
- Sponsor
- B. Braun Melsungen AG
Coronary Artery Disease, Angina Pectoris
Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents
The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity.
- Conditions
- Coronary Artery Disease, Angina Pectoris, Unstable Angina Pectoris, Acute Coronary Syndrome
- Trial name
- BIONYX (NCT02508714)
- Testing
- Orsiro, Resolute Onyx
- Where
- 7 sites in Belgium, Israel and 1 more
- Volunteers
- 2,470 people
- Sponsor
- Thorax Centrum Twente