Clinical trials: Drug Eluting Stent
Myocardial Infarction
Efficacy of Everolimus-Eluting Versus Zotarolimus-Eluting Sten for Coronary Lesions in Acute Myocardial Infarction
Most of the previous data regarding the efficacy of the everolimus-eluting stent (EES) was derived from studies comparing EES with bare metal stent (BMS) or EES with paclitaxel-eluting (PES).
- Trial name
- EVERZOTA (NCT01347554)
- Testing
- Everolimus eluting stent, Zotarolimus eluting stent
- Where
- South Korea
- Volunteers
- 461 people
- Sponsor
- Yonsei University
Coronary Artery Disease
A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s)
EVOLVE 48 is a prospective, open label, single arm, multi-center trial. The purpose of this study is to assess the FDA requirement for safety and effectiveness of the SYNERGY 48 mm Coronary Stent System for the treatment of…
- Trial name
- EVOLVE48 (NCT03350542)
- Testing
- SYNERGY 48 mm
- Where
- 15 sites in United States, Latvia and 2 more
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation
Coronary Occlusion, Thrombosis (Stent Thrombosis)
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
This is a prospective, randomized, active-controlled, open label, parallel two-arm, multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER SELECT PLUS Sirolimus-Eluting Coronary Stent System…
- Conditions
- Coronary Occlusion, Thrombosis (Stent Thrombosis), Vascular Disease, Myocardial Ischemia
- Trial name
- NCT01178268
- Testing
- XIENCE V EECSS, CYPHER SELECT PLUS SECSS
- Where
- 2 sites in China
- Volunteers
- 546 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia
The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia
Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs.
- Trial name
- SAVAL (NCT03551496)
- Testing
- Drug Eluting Stent - Below the Knee, Standard PTA Control Arm
- Where
- 42 sites in United States, Belgium and 3 more
- Volunteers
- 201 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
EDUCATE: The MEDTRONIC Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet Agents and Thrombotic Events
EDUCATE is a prospective, multi-center study designed to collect real-world safety and clinical outcomes in subjects receiving one or more Endeavor Zotarolimus-Eluting Stents and either clopidogrel and aspirin or prasugrel and…
- Trial name
- EDUCATE (NCT01069003)
- Testing
- Thienopyridine Therapy, Surveillance Arm
- Where
- United States
- Volunteers
- 2,272 people
- Sponsor
- Medtronic Vascular
Coronary Restenosis
SELUTION SLR™ 014 In-stent Restenosis
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial. Subjects with previous bare-metal stent (BMS) or Drug-Eluting Stent (DES) and qualifying evidence for In-stent Restenosis (ISR) will…
- Trial name
- SELUTION4ISR (NCT04280029)
- Testing
- SELUTION SLR 014 DEB, Standard of Care
- Where
- 48 sites in United States, Belgium and 5 more
- Volunteers
- 418 people
- Sponsor
- M.A. Med Alliance S.A.
Angina, Chronic Coronary Occlusion
XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan
The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the…
- Conditions
- Angina, Chronic Coronary Occlusion, Stent Thrombosis, Vascular Disease
- Trial name
- NCT01086228
- Testing
- XIENCE V / PROMUS stent
- Where
- 47 sites in Japan
- Volunteers
- 2,010 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
DynamX Bioadaptor Hong Kong Registry
Prospective, non-randomized, multicenter registry
- Trial name
- NCT04483791
- Testing
- DynamX Novolimus Eluting Coronary Bioadaptor System
- Where
- 4 sites in China
- Volunteers
- 50 people
- Sponsor
- Elixir Medical Corporation
Coronary Artery Disease
PROMUS Element Plus US Post-Approval Study
This study is designed to observe clinical outcomes in patients receiving the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.
- Trial name
- NCT01589978
- Testing
- PROMUS Element Plus Coronary Stent System, Aspirin, P2Y12 antagonist
- Where
- 52 sites in United States
- Volunteers
- 2,681 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Disease
Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent
The RESOLUTE-III Allcomers trial is a prospective, multicenter, randomized, two-arm, international, non-inferiority, open-label study with 2300 patients at 15-20 centers. The study is a "real world, all comers" study.
- Trial name
- RESOLUTE-AC (NCT00617084)
- Testing
- Medtronic Endeavor Resolute, Abbott Xience V
- Where
- Switzerland
- Volunteers
- 2,292 people
- Sponsor
- Medtronic Vascular
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
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
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
Peripheral Vascular Diseases
Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7…
- Trial name
- Zilver PTX (NCT00120406)
- Testing
- Zilver® PTX™ Drug Eluting Vascular Stent, Angioplasty
- Where
- 52 sites in United States, Germany and 1 more
- Volunteers
- 474 people
- Sponsor
- Cook Group Incorporated
Coronary Artery Disease
BIOTRONIK Orsiro Pre-Marketing Registration
The clinical investigation is a non-inferiority, multicenter, blinding evaluation, randomized, parallel controlled clinical study enrolling up to 440 subjects.
- Trial name
- BIOFLOW-VI (NCT02870985)
- Testing
- Coronary Stent
- Where
- China
- Volunteers
- 440 people
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
Coronary Artery Disease, Coronary Artery Stenosis
Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions
The ABSORB III PK sub-study is a prospective, open-label, non-blinded study enrolling approximately 12 subjects in up to 5 US sites. ABSORB III PK sub-study is a part of ABSORB III RCT (NCT01751906).
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
- Trial name
- NCT02229864
- Testing
- Coronary artery stenting: Absorb BVS
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Abbott Medical Devices
Antiplatelet Aggregation
A Study to Evaluate the Discontinuation Effect of Clopidogrel After Drug Eluting Stent Implantation in Non-diabetic Patients
The purpose of the study is to look at the biomarkers of inflammation and platelet activation in patients with drug eluting stents implanted approximately 12 months ago on aspirin and statin, for a 4-week period after the routine…
- Trial name
- DECADES (NCT00493779)
- Testing
- Blood Collection
- Where
- 6 sites in France, Germany and 2 more
- Volunteers
- 103 people
- Sponsor
- Bristol-Myers Squibb
Coronary Arteriosclerosis, Non ST Segment Elevation Acute Coronary Syndrome
HARMONEE - Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo StEnt
This is a multi-center, single-blind, randomized, active-controlled, clinical trial in Percutaneous Coronary Intervention (PCI) subjects.
- Trial name
- HARMONEE (NCT02073565)
- Testing
- OrbusNeich Combo stent™, Everolimus Eluting Stent (EES)
- Where
- 50 sites in United States, Japan
- Volunteers
- 572 people
- Sponsor
- OrbusNeich
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, 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.