Clinical trials: de Novo Coronary Lesions
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
Coronary Artery Disease, Arterial Occlusive Diseases
The ENDEAVOR II Clinical Trial: The Medtronic Endeavor Drug Eluting Coronary Stent System in Coronary Artery Lesions
To demonstrate the safety and efficacy of the Driver Coronary Stent coated with 10 mcg/mm ABT-578 compared to the uncoated Driver Stent for the treatment of single de novo lesions in native coronary arteries 2.25-3.5 mm in…
- Conditions
- Coronary Artery Disease, Arterial Occlusive Diseases, Coronary Disease, Coronary Arteriosclerosis
- Trial name
- ENDEAVOR II (NCT00614848)
- Testing
- Endeavor drug eluting coronary stent
- Where
- France
- Volunteers
- 1,200 people
- Sponsor
- Medtronic Vascular
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
The study objective is the assessment of safety and clinical performance of Freesolve 35- and 40-mm in de novo coronary artery lesions up to 38 mm length.
- Conditions
- Coronary Artery Disease, Atherosclerosis of Coronary Artery, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOMAG-LL (NCT07091682)
- Testing
- Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
- Where
- 14 sites in Germany, Hungary and 5 more
- Volunteers
- 100 people
- Sponsor
- Biotronik AG
Coronary Artery Disease
Safety and Efficacy of the CRE8 Stent for the Treatment of De Novo Coronary Artery Lesions
The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8 sirolimus-eluting stent and the RESOLUTE zotarolimus-eluting stent in the treatment of patients with de novo coronary artery lesions.
- Trial name
- NCT02360423
- Testing
- CRE8 sirolimus-eluting stent, RESOLUTE zotarolimus-eluting stent
- Where
- China
- Volunteers
- 430 people
- Sponsor
- CID S.p.A.
Coronary Disease
Randomized Trial of Coronary Angioplasty for de Novo Lesions in sMall vesSElS With Drug Eluting Balloon.
Significant lesions in small coronary arteries are frequently found (35%-50%) in patients with coronary artery disease. Independently of the type of coronary angioplasty the restenosis and the need for repeat revascularization…
- Trial name
- RAMSES (NCT01722799)
- Testing
- Drug elluting Balloon (DEB), Drug elluting coronary stent (DES)
- Where
- Spain
- Volunteers
- 97 people
- Sponsor
- Andres Iñiguez Romo, MD, PhD
Coronary Artery Disease
Elixir Medical Clinical Evaluation of the DESolve Myolimus Eluting Bioresorbable Coronary Stent System - DESolve I Trial
This prospective, consecutive enrolment, single-arm study will enroll up to 15 patients with single de novo, Type A lesions < 10 mm in length and located in a native coronary artery with a reference vessel diameter of 2.75 mm …
- Trial name
- NCT02086006
- Testing
- DESolve Novolimus Eluting Bioresorbable Coronary Scaffold
- Where
- 3 sites in Belgium, New Zealand
- Volunteers
- 16 people
- Sponsor
- Elixir Medical Corporation
Coronary Artery Disease
A Study of Diabetic Patients With De Novo Native Coronary Artery Lesions
The main objective of this study is to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx…
- Trial name
- SCORPIUS (NCT00495898)
- Testing
- CYPHER sirolimus-eluting stent, uncoated Bx VELOCITY balloon-expandable stent
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study.
The main objective of this study is to assess the safety and effectiveness of the sirolimus coated Bx VELOCITY stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the bare metal Bx…
- Trial name
- RAVEL (NCT00233805)
- Testing
- Sirolimus coated Bx Velocity™, Bare metal Bx Velocity™
- Where
- France
- Volunteers
- 220 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
Elixir Medical Clinical Evaluation of the DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System - The DESolve Nx Trial
To evaluate the safety, performance and efficacy of the Elixir DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System (BCSS) in patients with a single de novo native coronary artery lesion designated the target lesion…
- Trial name
- NCT02086045
- Testing
- DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System
- Where
- 13 sites in Belgium, Brazil and 4 more
- Volunteers
- 126 people
- Sponsor
- Elixir Medical Corporation
Lesion
Assessment of the Numen Stent With Evaluation in a Randomized Study
The purpose of this study is to Evaluate the Short-Term and Mid-Term Safety and Efficacy of the NUMEN Cobalt-Chromium coronary stent for the treatment of de novo lesions in native coronary arteries and compare it to the…
- Trial name
- ANSWERS (NCT00790283)
- Testing
- PTCA with stent implantation
- Where
- 8 sites in France
- Volunteers
- 500 people
- Sponsor
- International Biomedical Systems S.p.A.
Coronary Artery Disease
NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions
The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System (SDS) in patients with de novo native coronary…
- Trial name
- NCT00231283
- Testing
- CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
The Medtronic RESOLUTE US Clinical Trial
The objective of the study is to assess the safety and effectiveness of the Resolute Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter…
- Trial name
- R-US (NCT00726453)
- Testing
- Resolute Zotarolimus-Eluting Coronary Stent
- Where
- United States
- Volunteers
- 1,516 people
- Sponsor
- Medtronic Vascular
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
The goal of this clinical trial is to learn if the SiroMax™ drug-coated balloon catheter is safe and works to treat stenotic coronary lesions in adults.
- Conditions
- Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), In-Stent Restenosis or De Novo Coronary Artery Lesions, In-Stent Stenosis (Restenosis) of Coronary Artery Stent
- Trial name
- SMART-I (NCT07811024)
- Testing
- Sirolimus-coated balloon catheter
- Where
- 2 sites in Uzbekistan
- Volunteers
- 60 people
- Sponsor
- Tonic Medical, Inc.
Coronary Artery Disease
Infinnium-Core™ Registry for the Treatment of Patients With De Novo Coronary Lesions
The primary objective of Infinnium-Core™ Registry is to assess the safety and efficacy of the Infinnium-Core™ Paclitaxel Eluting Coronary Stent System in de novo Coronary Lesions.
- Trial name
- NCT00936780
- Testing
- Infinnium-Core™ Paclitaxel eluting Coronary Stent
- Where
- 7 sites in India
- Volunteers
- 67 people
- Sponsor
- Sahajanand Medical Technologies Limited
Coronary Artery Disease
Clinical Trial of Cilostazol Eluting Stent System (CES-1) in De Novo Coronary Artery Lesions
The purpose of the this trial is to evaluate the clinical safety and efficacy of Cilostazol eluting stent system (CES-1) for the treatment of single de novo lesions in native coronary arteries.
- Trial name
- NCT03189641
- Testing
- Cilostazol eluting stent system (CES-1)
- Where
- 6 sites in Japan
- Volunteers
- 30 people
- Sponsor
- JIMRO Co., Ltd.
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
Coronary Artery Disease, Stenosis Coronary
SPAGO: Sirolimus Paclitaxel Angiographic Gain Objective
The objective of the study is to compare angiographic outcomes of Selution sirolimus coated balloon (MedAlliance) versus SeQuent Please Neo paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions…
- Conditions
- Coronary Artery Disease, Stenosis Coronary, Coronary Artery Lesion, Percutaneous Coronary Intervention
- Trial name
- SPAGO (NCT06373601)
- Testing
- sirolimus-eluting balloon (Selution), paclitaxel-eluting balloon (SeQuent Please Neo)
- Where
- 10 sites in Italy
- Volunteers
- 140 people
- Sponsor
- Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
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 study is to assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary…
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOFLOW-V (NCT02389946)
- Testing
- Orsiro DES, Xience DES
- Where
- 92 sites in United States, Australia and 11 more
- Volunteers
- 1,334 people
- Sponsor
- Biotronik, Inc.
Coronary Stenosis
Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stents to Treat De Novo Coronary Lesions
The primary objective of this study is to further evaluate the safety and effectiveness of the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in long lesion lengths, small and large vessel diameters and with multiple…
- Trial name
- NCT00301522
- Testing
- TAXUS Paclitaxel-Eluting Coronary Stent, Slow-Formulation, Express2
- Where
- 72 sites in United States
- Volunteers
- 1,108 people
- Sponsor
- Boston Scientific Corporation
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.