Clinical trials: Native Coronary Artery Stenosis
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, Everolimus
SPIRIT FIRST Clinical Trial of the Abbott Vascular XIENCE V® Everolimus Eluting Coronary Stent System
Prospective, randomized, controlled, single-blinded, parallel two-arm, multicenter trial. Test arm: XIENCE V® Everolimus Eluting Coronary Stent System(stent length: 18mm, diameter: 3.0mm) Control arm: Metallic stent (MULTI-LINK…
- Conditions
- Coronary Artery Disease, Everolimus, Vascular Disease, Myocardial Ischemia
- Trial name
- NCT00180453
- Testing
- Coronary artery drug eluting stent placement, Coronary artery stent placement
- Where
- 7 sites in Denmark, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Abbott Medical Devices
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
Coronary Artery Stenosis
Biorest Liposomal Alendronate With Stenting sTudy (BLAST)
The main objective of this study is to assess the safety and efficacy of Liposomal Alendronate in the treatment of de novo stenotic lesions in native coronary arteries in a population undergoing PCI with implantation of a bare…
- Trial name
- BLAST (NCT00739466)
- Testing
- Liposomal Alendronate
- Where
- 12 sites in Israel
- Volunteers
- 226 people
- Sponsor
- BIOrest Ltd.
Coronary Artery Disease, Coronary Artery Stenosis
The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries
The objective of this study is to verify the safety and efficacy of the investigational device (ELX1805J) for the treatment of ischemic heart disease due to de novo, native coronary artery lesions
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- BIOADAPTOR RCT (NCT04192747)
- Testing
- Percutaneous Coronary Intervention
- Where
- 36 sites in Belgium, Germany and 2 more
- Volunteers
- 445 people
- Sponsor
- Elixir Medical Corporation
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
ABSORB II Randomized Controlled Trial
Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to…
- Trial name
- ABSORB II (NCT01425281)
- Testing
- Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System, Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
- Where
- Belgium
- Volunteers
- 501 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, Coronary Restenosis
Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary Arteries
The process of re-narrowing of a coronary artery following a revascularization procedure such as angioplasty, begins at the time of the procedure.
- Trial name
- NCT00248066
- Testing
- RESTEN-MP
- Where
- 3 sites in Germany
- Volunteers
- 50 people
- Sponsor
- Sarepta Therapeutics, Inc.
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, Native Coronary Artery Stenosis
MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels
This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease.
- Conditions
- Coronary Artery Disease, Native Coronary Artery Stenosis, Cardiovascular Diseases
- Trial name
- MAGICAL SV (NCT06271590)
- Testing
- Sirolimus Drug Coated Balloon, Drug eluting stents (DES)
- Where
- 24 sites in United States
- Volunteers
- 1,605 people
- Sponsor
- Concept Medical Inc.
Coronary Disease, Coronary Artery Disease
ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation
Prospective, open-labeled First in Man Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm receiving a single 3.0 x 12 mm or 3.0 x 18 mm BVS EECSS containing 98 microgramme per cm²…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- ABSORB A (NCT00300131)
- Testing
- Bioabsorbable Everolimus Eluting Coronary Stent
- Where
- 4 sites in Denmark, Netherlands and 2 more
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Artery Stenosis
ABSORB III Randomized Controlled Trial (RCT)
The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- ABSORB-III (NCT01751906)
- Testing
- Absorb BVS, XIENCE
- Where
- 192 sites in United States, Australia
- Volunteers
- 2,008 people
- Sponsor
- Abbott Medical Devices
In-stent Coronary Artery Restenosis
Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in In-Stent Restenosis Lesions (DEBREST)
The purpose of this study is to assess safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of In-Stent Restenosis lesions in native coronary arteries.
- Trial name
- DEBREST (NCT01485068)
- Testing
- Danubio paclitaxel-eluting balloon
- Where
- 8 sites in France
- Volunteers
- 44 people
- Sponsor
- MINVASYS
Coronary Artery Disease
SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
The purpose of the SPIRIT IV Clinical Trial is to continue to evaluate the safety and efficacy of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V®).
- Trial name
- NCT00307047
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 65 sites in United States
- Volunteers
- 3,687 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 Disease, Coronary Artery Disease
SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- SPIRIT II (NCT00180310)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 32 sites in Austria, Belgium and 11 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Stents, Coronary Artery Disease
SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
This study is divided into 5 arms: 1. Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V®…
- Conditions
- Stents, Coronary Artery Disease, Total Coronary Occlusion, Coronary Artery Restenosis
- Trial name
- NCT00180479
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 65 sites in United States
- Volunteers
- 1,002 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Coronary Artery Stenosis
Pre-market Study of the DREAMS 2G Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-III)
BIOSOLVE-III Study is a pre-market, prospective, multi-center trial to assess the acute clinical performance of the DREAMS 2G Drug-Eluting Coronary Scaffold in de novo coronary artery lesions.
- Trial name
- BIOSOLVE-III (NCT02716220)
- Testing
- Percutaneous Coronary Intervention
- Where
- 8 sites in Belgium, Germany and 2 more
- Volunteers
- 61 people
- Sponsor
- Biotronik AG
In-Stent Stenosis (Restenosis) of Coronary Artery Stent, Native Coronary Artery Stenosis
BIOFLOW-china Post-marketing Study (BIOTRONIK)
This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods.
- Trial name
- BIOFLOW-China (NCT05667285)
- Testing
- BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System
- Where
- 2 sites in China
- Volunteers
- 122 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.