Clinical trials: Coronary Stenting
Stenosis
BIONICS Israel Trial
This study aims to assess the device success and the safety of Medinol's Drug Eluting Stent - BioNIR - with a modified delivery system.
- Trial name
- NCT02834806
- Testing
- BioNIR Ridaforolimus Eluting Coronary Stent System
- Where
- Israel
- Volunteers
- 58 people
- Sponsor
- Medinol Ltd.
Coronary Artery Disease
Study to Evaluate the Safety of Cronus® - Cobalt Chromium Coronary Stent
The objective this study is evaluate the performance and safety of Chronus® cobalt-chromium coronary stent in patients with "de novo" native coronary artery lesions treated with 19-mm-long stents in long-term 9 months.
- Trial name
- CRONUS (NCT01090609)
- Testing
- Stent implantation
- Where
- 13 sites in Brazil
- Volunteers
- 263 people
- Sponsor
- Scitech Produtos Medicos SA
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III Hungary 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
- NCT01892917
- Where
- 13 sites in Hungary
- Volunteers
- 2,000 people
- Sponsor
- Biotronik Hungária Kft.
Coronary Artery Disease
Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent
BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the Xience Prime / Xience Xpedition (Xience)drug…
- Trial name
- BIOFLOW-IV (NCT01939249)
- Testing
- Abbott Laboratories Xience, Biotronik Orsiro
- Where
- 45 sites in Australia, Belgium and 10 more
- Volunteers
- 585 people
- Sponsor
- Biotronik AG
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
Ischemic Heart Disease, Stenotic Coronary Lesion
RESOLUTE China Registry:
To document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a real-world patient population requiring stent implantation.
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- R-C Registry (NCT01243749)
- Where
- 6 sites in China
- Volunteers
- 1,800 people
- Sponsor
- Medtronic Vascular
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW III Asia Registry Orsiro Stent System
Cliflical evaluation of th' Orsiro LESS 10 diabetic subjects requiring coronary revasculariza t ion with Drug Eluting Stefl ts (DES) .880 subjects will be enrolled in this registry.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia, Diabetes Mellitus Type 1 or 2
- Trial name
- NCT01941290
- Where
- 19 sites in China, India and 3 more
- Volunteers
- 387 people
- Sponsor
- BIOTRONIK Asia Pacific Pte Ltd
Angina Pectoris, Coronary Artery Disease
A Safety Study of ABI-007 for In-Stent Restenosis
This trial will treat patients with a new chemotherapeutic medicine who have undergone a successful and uncomplicated de novo stent placement in up to two native coronary arteries.
- Trial name
- NCT00093223
- Testing
- Paclitaxel Nanoparticle Albumin Bound
- Where
- United States
- Volunteers
- 76 people
- Sponsor
- Celgene
Coronary Heart Disease, Stable Angina Pectoris
BuMA OCT Study(A Comparative Evaluation of the Extent of Neointima Formation at 3 Months After Implantation Using OCT)
The objective of this study is a comparative evaluation of BuMA stent and of EXCEL stent in terms of the extent of neointima formation at 3 months after implantation using OCT.
- Conditions
- Coronary Heart Disease, Stable Angina Pectoris, Unstable Angina Pectoris, Silent Myocardial Ischemia
- Trial name
- NCT01752582
- Testing
- BuMA stent, EXCEL stent
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Sino Medical Sciences Technology Inc.
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.
Ischemic Heart Disease, Stable Coronary Artery Disease
To Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent
to evaluate safety and efficacy of CGBIO stent(DES) compared to Biomatrix flex stent(DES)
- Conditions
- Ischemic Heart Disease, Stable Coronary Artery Disease, Stable Angina, Unstable Angina
- Trial name
- NCT03089450
- Testing
- CGBio stent, Biomatrix flex
- Where
- South Korea
- Volunteers
- 112 people
- Sponsor
- CGBio Inc.
Coronary Artery Disease, Cardiac Death
BioFreedom QCA Study in CAD Patients
This study aims to demonstrate that the BioFreedom™ Cobalt Chromium Drug Coated Stent is non-inferior to the market authorized BioFreedom™ Stainless Steel Stent with respective to efficacy and shows a similar safety profile.
- Conditions
- Coronary Artery Disease, Cardiac Death, Myocardial Infarction
- Trial name
- BioFreedomQCA (NCT03307213)
- Testing
- BioFreedom™ CoCr Biolimus A9™ stent, BioFreedom™ SS Biolimus A9™ stent
- Where
- 2 sites in Denmark, Spain
- Volunteers
- 200 people
- Sponsor
- Biosensors Europe SA
Vascular Disease, Myocardial Ischemia
A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population
The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease…
- Conditions
- Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease
- Trial name
- SV JAPAN (NCT01115933)
- Testing
- XIENCE PRIME SV EECSS
- Where
- 14 sites in Japan
- Volunteers
- 65 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Tryton Post Approval Study (PAS) for the Tryton Side Branch Stent
TRYTON Post Approval Study (PAS) of the Tryton Side Branch Stent
- Trial name
- PAS (NCT03318796)
- Testing
- Coronary Artery Stenting
- Where
- United States
- Volunteers
- 335 people, healthy volunteers welcome
- Sponsor
- Tryton Medical, Inc.
Coronary Artery Disease
Prevail Global Study
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
- Trial name
- NCT06535854
- Testing
- Prevail DCB, Agent DCB
- Where
- 79 sites in United States, Canada and 7 more
- Volunteers
- 1,205 people
- Sponsor
- Medtronic Vascular
Coronary Artery Disease
A Registry Trial of The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
This study is a prospective, multi-center single arm registry trial, planning to enroll 785 subjects. All subjects will receive clinical follow-up at 1 month, 6 month, 9 month and 1, 2, 3, 4, 5 year after index procedure.
- Trial name
- NCT04179045
- Testing
- The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
- Where
- 5 sites in China
- Volunteers
- 785 people
- Sponsor
- Shanghai Bio-heart Biological Technology Co., Ltd.
Coronary Artery Disease, Myocardial Ischemia
Safety and Efficacy Study of the Amaranth Medical MAGNITUDE Bioresorbable Drug-Eluting Coronary Stent (RENASCENT III)
The purpose of this study is to evaluate the safety and performance of a new version of a coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle.
- Trial name
- RENASCENT III (NCT02900937)
- Testing
- AmM MAGNITUDE Bioresorbable Drug-Eluting Coronary Scaffold
- Where
- 13 sites in Colombia, Italy
- Volunteers
- 70 people
- Sponsor
- Amaranth Medical Inc.
Coronary Artery Disease
The CYPHER™ Stent Study in Patients With Small de Novo Coronary Artery Lesions.
The main objective of this study is to assess the effectiveness of the CYPHER™ (sirolimus-eluting) stent in reducing in-lesion late lumen loss in de novo native coronary artery lesions in small vessels (2.25 - 2.75 mm) as…
- Trial name
- SVELTE (NCT00235066)
- Testing
- PCI
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
Study Safety and Performance of the Biomime Stent in Patients With Single, De Novo, Non-Complex Coronary Lesions
1.) Indigenously developed and designed BioMimeTM is a predictably safe \& efficacious 3rd generation drug eluting stent (DES) with a propensity to minimize vascular injury by use of an intelligent mix of ultra-low strut…
- Trial name
- meriT-1 (NCT01507519)
- Testing
- Sirolimus Eluting Coronary Stent System (Biomime)
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Meril Life Sciences Pvt. Ltd.
Coronary Restenosis
Treatment of Coronary In-stent Restenosis (ISR) by a Sirolimus Coated or a Paclitaxel Coated Balloon
Treatment of coronary in-stent restenosis (ISR) by a sirolimus coated SEQUENT® SCB RAPID EXCHANGE PTCA balloon catheter or a paclitaxel coated SEQUENT® PLEASE PTCA balloon catheter
- Trial name
- NCT03242096
- Testing
- Sirolimus coated balloon, Paclitaxel coated balloon
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 50 people
- Sponsor
- InnoRa GmbH