Clinical trials: Ischemic Lesions
Coronary Artery Disease
TAXUS PERSEUS Small Vessel
The purpose of the TAXUS PERSEUS Small Vessel trial is to evaluate the safety and efficacy of the next-generation Boston Scientific TAXUS paclitaxel-eluting coronary stent system (TAXUS® ElementTM) for the treatment of de novo…
- Trial name
- PERSEUS SV (NCT00489541)
- Testing
- Percutaneous Coronary Intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
- Where
- 28 sites in United States
- Volunteers
- 224 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
The Dual Antiplatelet Therapy Study (DAPT Study)
The DAPT Study is a double blind randomized controlled trial intended to determine the appropriate duration for dual antiplatelet therapy (the combination of aspirin and a second anti-clotting medication) as well as the safety…
- Trial name
- NCT00977938
- Testing
- Clopidogrel & Aspirin, Prasugrel & Aspirin
- Where
- 256 sites in United States, Australia and 8 more
- Volunteers
- 25,682 people
- Sponsor
- Baim Institute for Clinical Research
Peripheral Artery Disease, Critical Limb Ischemia
Complete Lesion Assessment With ffR and IVUS TechnologY
CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).
- Trial name
- CLARITY I (NCT01941030)
- Testing
- Orbital Atherectomy System, Balloon Angioplasty
- Where
- 8 sites in United States
- Volunteers
- 51 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Atherosclerosis
Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems
The objective of this study is to show similar (non-inferior) safety and effectiveness between CYPHER® ELITE™ and CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems in a prospective, multi-center, randomized clinical study for…
- Trial name
- ELITE (NCT00715884)
- Testing
- CYPHER® ELITE™ Sirolimus-Eluting Stent System, CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
- Where
- United States
- Volunteers
- 678 people
- Sponsor
- Cordis US Corp.
Systemic Sclerosis
Open-Label Study of Oral Treprostinil in Digital Ulcers
This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects…
- Trial name
- DISTOL-EXT (NCT00848107)
- Testing
- treprostinil diethanolamine
- Where
- 26 sites in United States, Canada and 1 more
- Volunteers
- 115 people
- Sponsor
- United Therapeutics
Coronary Artery Disease
PLATINUM Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions-Pharmacokinetics (PLATINUM PK)
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions.
- Trial name
- PLATINUM PK (NCT01510327)
- Testing
- PROMUS Element Everolimus-Eluting Coronary Stent System, Aspirin, Thienopyridine
- Where
- 5 sites in United States, Japan
- Volunteers
- 22 people
- Sponsor
- Boston Scientific Corporation
Angioplasty, Cardiovascular Disease
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.
- Conditions
- Angioplasty, Cardiovascular Disease, Coronary Artery Disease, Coronary Heart Disease
- Trial name
- XP China SAS (NCT01894152)
- Testing
- XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
- Where
- United States
- Volunteers
- 2,002 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Endeavor Zotarolimus - Eluting Stent in the Treatment Lesions in Small Native Coronary Arteries.
The objective of this study is to verify the safety and efficacy of the Endeavor Zotarolimus-Eluting Coronary Stent System for improving coronary luminal diameter in patients with ischemic heart disease due to de novo lesions of…
- Trial name
- ENDEAVORSVS (NCT00609947)
- Testing
- Endeavor Zotarolimus-Eluting Coronary Stent
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- Medtronic Vascular
Critical Limb Ischemia (CLI)
LIFE-BTK PK Sub-study
LIFE-BTK PK is a prospective, single-arm, open-label, non-blinded, non-randomized sub-study of LIFE-BTK Randomized Controlled Trial (NCT04227899), that will enroll approximately 7 subjects in the United States (US) and outside…
- Trial name
- NCT05208905
- Testing
- Esprit BTK Device
- Where
- 5 sites in United States, Australia and 1 more
- Volunteers
- 9 people
- Sponsor
- Abbott Medical Devices
Coronary Disease, Coronary Artery Disease
ABSORB Clinical Investigation, Cohort B
The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ABSORB B (NCT00856856)
- Testing
- Bioabsorbable Everolimus Eluting Coronary Stent
- Where
- 12 sites in Australia, Belgium and 6 more
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Atherosclerosis, Coronary
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device…
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOFLOW-VII (NCT04175626)
- Testing
- Orsiro DES
- Where
- 33 sites in United States
- Volunteers
- 556 people
- Sponsor
- Biotronik, Inc.
Coronary Artery Disease
The ROB-OSTIAL Study
The purpose of this study is to compare the accuracy of robotic-assisted percutaneous coronary intervention (PCI) using the CorPath GRX® System, versus standard PCI when treating ostial lesions.
- Trial name
- NCT05634538
- Testing
- Robotic-assisted PCI with Corpath GRX® System, Standard PCI
- Where
- Italy
- Volunteers
- 1 people
- Sponsor
- Siemens Healthineers Endovascular Robotics, Inc.
Stable Angina, Heart Failure
Plasmonic Nanophotothermal Therapy of Atherosclerosis
The investigators hypothesize that the nanoburning is a very challenging technique to demolish and reverse the plaque especially in combination with stem cell technologies promising the functional restoration of the vessel wall.
- Conditions
- Stable Angina, Heart Failure, Atherosclerosis, Multivessel Coronary Artery Disease
- Trial name
- NANOM-FIM (NCT01270139)
- Testing
- Transplantation of nanoparticles, Transplantation of iron-bearing nanoparticles, Stenting
- Where
- 4 sites in Netherlands, Russia
- Volunteers
- 180 people
- Sponsor
- Ural State Medical University
Coronary Artery Disease
Coronary Flow Reserve Following Orbital Atherectomy
The purpose of the study was to evaluate coronary artery flow reserve (CFR) following successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions by orbital atherectomy and stenting.
- Trial name
- NCT02339545
- Testing
- Coronary Orbital Atherectomy plus Stenting
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Abbott Medical Devices
Arterial Occlusion, Cardiovascular Diseases
Comparing TR Band to Statseal in Conjunction With TR Band II
The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transradial procedures.
- Conditions
- Arterial Occlusion, Cardiovascular Diseases, Atherosclerosis, Hematoma
- Trial name
- Statseal II (NCT04046952)
- Testing
- Statseal with TR Band, TR band only
- Where
- United States
- Volunteers
- 443 people
- Sponsor
- VA Long Beach Healthcare System
Atherosclerosis, Coronary Artery Disease
Prospective, Randomized, Multicenter Trial to Assess PROMUS™ Element™ Stent
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System for the treatment of subjects in China with a single de novo atherosclerotic coronary artery…
- Trial name
- PTChina (NCT01285999)
- Testing
- PROMUS Element Coronary Stent System, TAXUS Liberté Coronary Stent System
- Where
- 15 sites in China
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Ischemic Heart Disease, Coronary Artery Stenosis
A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions
This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention…
- Conditions
- Ischemic Heart Disease, Coronary Artery Stenosis, Chronic Coronary Total Occlusion, Coronary Bypass Graft Stenosis
- Trial name
- CROSS (NCT01186198)
- Testing
- MINI TREK RX 1.20 mm Coronary Dilatation Catheter
- Where
- 4 sites in United States
- Volunteers
- 71 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Abbott Next Generation Drug Eluting Stent 48mm Study
The purpose of this SPIRIT 48 study is to evaluate the safety and effectiveness of the ABT NG DES 48 in improving coronary artery luminal diameter in subjects with coronary artery disease (CAD) due to de novo native coronary…
- Trial name
- SPIRIT 48 (NCT04282148)
- Testing
- ABT NG DES 48 EECSS
- Where
- 25 sites in United States, Australia and 1 more
- Volunteers
- 107 people
- Sponsor
- Abbott Medical Devices
Stable Angina
Outcome of Coronary High Angulated Bifurcation Lesions Treated With Kissing Ballooning or Sequential Ballooning Techniques
Coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis. Their structural properties make angioplasty technique to increase the difficulty of implementation, but also increased the risks of the…
- Trial name
- MV:main branch (NCT02137486)
- Where
- Taiwan
- Volunteers
- 214 people
- Sponsor
- Taipei City Hospital
Peripheral Arterial Disease, Critical Limb Ischemia
A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)
This is a prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System).
- Trial name
- DEEPER REVEAL (NCT05358353)
- Testing
- Bare Temporary Spur Stent System
- Where
- 48 sites in United States
- Volunteers
- 130 people
- Sponsor
- ReFlow Medical, Inc.