Clinical trials: de Novo Lesions in Native Coronary Arteries
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.
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
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.
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
Coronary Artery Disease
A Study of the Presillion Stent in de Novo Coronary Lesions
The PRESILLION Study is a non-randomized, multi-center, single-arm study evaluating the safety of an approved Cobalt Chromium bare metal stent system for the treatment of ischemic heart disease attributable to a stenotic de novo…
- Trial name
- PRESILLION (NCT00722579)
- Testing
- PRESILLION cobalt chromium stent
- Where
- Belgium
- Volunteers
- 101 people
- Sponsor
- Cordis US Corp.
Coronary Atherosclerosis
Comparison of the Conor Sirolimus-eluting Coronary Stent to the Taxus Liberte Paclitaxel-eluting Coronary Stent in the Treatment of Coronary Artery Lesions
The purpose of this study is to evaluate the safety and effectiveness of the Conor Sirolimus-eluting Coronary Stent System in the treatment of coronary artery disease (a single atherosclerotic lesion) in native coronary arteries.
- Trial name
- NEVO RES-I (NCT00606333)
- Testing
- NEVO™ Sirolimus-eluting Coronary Stent System, Drug-eluting stent (TAXUS Liberte Paclitaxel-eluting Coronary Stent System)
- Where
- 2 sites in Brazil, New Zealand
- Volunteers
- 394 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease
Resolute Integrity US Extended Length Sub-Study(RI US XL)
Prospective, multi-center, non-randomized, single-arm, open-label study to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel…
- Trial name
- RI-US XL (NCT01913600)
- Testing
- Resolute Integrity Stent
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Medtronic Vascular
Coronary Artery Disease
The Clinical Evaluation of the Cinatra™ Corolimus-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries
To investigate the safety and efficacy of the Cinatra™ Corolimus Drug Eluting Stent for the treatment of de novo lesions in native coronary arteries.
- Trial name
- VANTAGE-1 (NCT01025869)
- Testing
- Cinatra™ Corolimus Eluting Coronary Stent System
- Where
- 4 sites in New Zealand
- Volunteers
- 31 people
- Sponsor
- Atrium Medical Corporation
Coronary Artery Disease, Atherosclerosis, Coronary
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System
The objective of this study is to assess the safety and efficacy of the Freesolve in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to a contemporary drug eluting stent (DES).
- Conditions
- Coronary Artery Disease, Atherosclerosis, Coronary, Myocardial Ischemia, Ischemic Heart Disease
- Trial name
- BIOMAG-II (NCT05540223)
- Testing
- Freesolve RMS, Xience DES
- Where
- Germany
- Volunteers
- 1,861 people
- Sponsor
- Biotronik AG
Coronary Artery Disease, Myocardial Ischemia
AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart…
- Trial name
- ABSORB JAPAN (NCT01844284)
- Testing
- XIENCE PRIME®/XIENCE Xpedition™, Absorb™ BVS
- Where
- 39 sites in Japan
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Hydroxyapatite Active Pro Healing Clinical Trial Program
The purpose of this first feasibility study is to evaluate the performance of Vesta™ \& VestaCOR™ (Hydroxy-Apetite coated GenX) stent in de novo native coronary artery lesions.
- Trial name
- HApFIM (NCT00474084)
- Testing
- Intravascular Coronary Stent
- Volunteers
- 70 people
- Sponsor
- BioSync Scientific Pvt. Ltd.
Coronary Artery Disease
Safety and Clinical Performance of a Sirolimus-eluting Absorbable Metal Scaffold
Assessment of the clinical performance and the safety of the Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold in a cohort of patients in India with de novo coronary artery lesions.
- Trial name
- BIOSOLVE-India (NCT02916485)
- Testing
- Bioresorbable scaffold
- Where
- India
- Volunteers
- 100 people
- Sponsor
- Biotronik AG
Coronary Artery Disease, Coronary Artery Stenosis
A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)
To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native…
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB CHINA (NCT01923740)
- Testing
- XIENCE V EECSS, Absorb BVS System
- Where
- United States
- Volunteers
- 480 people
- Sponsor
- Abbott Medical Devices