Clinical trials: de Novo Coronary Lesions
Coronary Artery Disease
The Arterial Revascularization Therapies Study Part II.
The main objective is to compare the effectiveness of coronary stent implantation using the sirolimus-eluting Bx VELOCITY™ balloon expandable stent with that of surgery as observed in ARTS I.
- Trial name
- ARTS II (NCT00235170)
- Testing
- drug-eluting stent
- Where
- Netherlands
- Volunteers
- 607 people
- Sponsor
- Cordis US Corp.
Coronary Disease
Cobalt Chromium Stent With Antiproliferative for Restenosis II Trial (COSTAR II)
The purpose of this study is to evaluate the safety and effectiveness of the investigational stent CoStar™ Paclitaxel-Eluting Coronary Stent- a reservoir based DES system in comparison to a surface coated DES stent (TAXUS™…
- Trial name
- NCT00165035
- Testing
- CoStar Paclitaxel Drug Eluting Coronary Stent System, TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent
- Where
- 2 sites in United States
- Volunteers
- 1,701 people
- Sponsor
- Cordis US Corp.
Stable Angina, Unstable Angina
International Randomized Comparison Between DES Limus Carbostent and Taxus DES in the Treatment of De-novo Coronary Lesions
The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic lesions in native coronary arteries.
- Conditions
- Stable Angina, Unstable Angina, Documented Silent Ischemia
- Trial name
- NEXT (NCT01373502)
- Testing
- DES Limus Carbostent, Taxus Liberté Stent
- Where
- 11 sites in Belgium, France and 2 more
- Volunteers
- 323 people
- Sponsor
- CID - Carbostent & Implantable Devices
Coronary Artery Disease
Diabetes Drug Eluting Sirolimus Stent Experience in Restenosis Trial
The main objective of this study is to assess the safety and effectiveness of the Sirolimus-eluting stent CYPHERTM and/or updated version in reducing angiographic in-stent late loss in de novo native coronary lesions of diabetic…
- Trial name
- DESSERT (NCT00497172)
- Testing
- CYPHER Sirolimus-eluting stent, Bx SONIC bare metal stent
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Cordis US Corp.
Coronary Arteriosclerosis
Safety and Efficacy of the Combo Bio-engineered Sirolimus-eluting Stent Versus the Nano Polymer-free Sirolimus-eluting Stent in the Treatment of Patients With de Novo Stenotic Lesions
To evaluate the safety, efficacy and deliverability of the Combo bio-engineered sirolimus-eluting stent versus the Nano polymer-free sirolimus- eluting stents in the treatment of patients with de novo stenotic lesions of native…
- Trial name
- RECOVERY (NCT02542007)
- Testing
- OrbusNeich Combo stent™, sirolimus-eluting stent system
- Where
- 15 sites in China
- Volunteers
- 440 people
- Sponsor
- OrbusNeich
de Novo Lesions in Native Coronary Arteries
First in Man Trial - BIOSOLVE-I
First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety
- Trial name
- BIOSOLVE-I (NCT01168830)
- Testing
- AMS-3.0
- Where
- 6 sites in Belgium, Germany and 2 more
- Volunteers
- 46 people
- Sponsor
- Biotronik AG
Atherosclerosis, Coronary Artery Disease
The OMEGA Clinical Trial
The purpose of this study is to evaluate the safety and effectiveness of the OMEGA Coronary Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery lesion.
- Trial name
- NCT01419171
- Testing
- OMEGA™ Monorail Coronary Stent System
- Where
- 37 sites in United States, Belgium and 5 more
- Volunteers
- 328 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
The TRIMAXX Coronary Stent Trial
The primary objective of the trial is to demonstrate the safety and feasibility of treating coronary artery lesions which have not been previously treated with the TRIMAXX Coronary stent system as compared to the reported results…
- Trial name
- NCT00596661
- Testing
- TriMaxx Coronary Stent placement
- Where
- 3 sites in Brazil, Germany
- Volunteers
- 100 people
- Sponsor
- Abbott Medical Devices
Coronary Disease, Coronary Artery Disease
SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of patients with de novo coronary artery…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- NCT01171820
- Testing
- TAXUS® Liberté™, XIENCE V® EECSS
- Where
- 28 sites in Austria, France and 9 more
- Volunteers
- 324 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Artery Stenosis
Absorb IV Randomized Controlled Trial
ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 2610 subjects from approximately 140 sites in the United States and outside the United States.
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- NCT02173379
- Testing
- Absorb BVS, XIENCE
- Where
- 120 sites in United States, Australia and 3 more
- Volunteers
- 2,604 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Cobra II Study: Use of the Cobra™ Cobalt Super Alloy Coronary Stent System in the Treatment of Coronary Artery Disease
To demonstrate the safety and efficacy of the Cobra Cobalt Super Alloy Balloon-Expandable Coronary Stent System for the treatment of de novo and restenotic (previously unstented) lesions in native coronary arteries in subjects…
- Trial name
- NCT00744107
- Testing
- PCI with the Cobra™ Cobalt Super Alloy Coronary Stent System
- Where
- 7 sites in Germany, Israel and 2 more
- Volunteers
- 258 people
- Sponsor
- Medlogics Device Corporation
Coronary Disease
Safety and Efficacy Study of the Nile PAX Drug-Eluting Coronary Bifurcation Stent
The purpose of this trial is to assess the safety and efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with a main branch…
- Trial name
- BIPAX (NCT01308229)
- Testing
- Nile PAX® paclitaxel-eluting coronary stent
- Where
- 10 sites in Brazil, Bulgaria and 5 more
- Volunteers
- 102 people
- Sponsor
- MINVASYS
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
Arterial Occlusive Diseases, Myocardial Ischemia
RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent
The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent for the treatment of de novo lesions in native coronary arteries.
- Conditions
- Arterial Occlusive Diseases, Myocardial Ischemia, Cardiovascular Diseases, Coronary Artery Disease
- Trial name
- RJ (NCT00927940)
- Testing
- MDT-4107 Drug Eluting Stent
- Where
- 14 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Medtronic Vascular
Coronary Artery Disease
A Safety and Efficacy of Supralimus™ Core™ Sirolimus Eluting Stent at MAX DDHV Institute
OBJECTIVES: The primary objective of this study is to assess the safety and efficacy of the Supralimus - Core™ Sirolimus Eluting Stent in de novo native vessel obstructive coronary artery disease.
- Trial name
- Maximus (NCT00811616)
- Testing
- Supralimus-Core™, Supralimus™ Core™ Sirolimus eluting stent
- Where
- India
- Volunteers
- 105 people
- Sponsor
- Sahajanand Medical Technologies Limited
Coronary Arteriosclerosis
Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent
The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.
- Trial name
- NCT00968019
- Testing
- Presillion stent
- Where
- 13 sites in Portugal, Spain
- Volunteers
- 318 people
- Sponsor
- Johnson and Johnson, S.A.
Coronary Artery Disease
A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)
PIONEER-II OPC trial is a prospective, multicenter, single-arm registry trial. 1000 subjects from approximately 40 interventional cardiology centers will be enrolled to evaluate the target lesion failure(TLF) as the primary…
- Trial name
- OPC (NCT02698852)
- Testing
- BuMA Supreme
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Sino Medical Sciences Technology Inc.
De Novo and Re-stenosed Coronary Artery Lesions
Long Term Safety Profile of the PRO-Kinetic ENERGY Coronary Stent System in Daily Clinical Practice
To evaluate the clinical performance of the PRO-Kinetic ENERGY® coronary bare metal stent system in a patient population within that defined in the Instructions for Use.
- Trial name
- ENERGY (NCT01056120)
- Testing
- Pro Kinetic Energy bare metal stent
- Where
- 50 sites in Austria, Belgium and 8 more
- Volunteers
- 1,026 people
- Sponsor
- Biotronik AG
Coronary Artery Disease
Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions
This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the OAS in treating de novo, severely calcified coronary lesions in adult subjects.
- Trial name
- ORBIT II (NCT01092416)
- Testing
- Diamondback 360 Orbital Atherectomy System
- Where
- 51 sites in United States
- Volunteers
- 443 people
- Sponsor
- Abbott Medical Devices
Myocardial Ischemia, Coronary Artery Stenosis
ABSORB EXTEND Clinical Investigation
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular.
- Conditions
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease
- Trial name
- ABSORB EXTEND (NCT01023789)
- Testing
- ABSORB BVS
- Where
- 56 sites in Argentina, Australia and 23 more
- Volunteers
- 812 people
- Sponsor
- Abbott Medical Devices