Clinical trials: Drug-eluting Stent
Saphenous Vein Graft Atherosclerosis
Drug-Eluting Stents vs. Bare Metal Stents In Saphenous Vein Graft Angioplasty
Patients who have undergone coronary bypass surgery have had a vein removed from the leg and implanted in the chest to "bypass" blockages in the coronary arteries. These veins are called saphenous vein grafts or SVGs.
- Trial name
- DIVA (NCT01121224)
- Testing
- Bare Metal Stent, Drug-Eluting Stent, Blinded clopidogrel
- Where
- 25 sites in United States
- Volunteers
- 597 people
- Sponsor
- VA Office of Research and Development
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
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
Angina, Coronary Occlusion
XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and…
- Conditions
- Angina, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis
- Trial name
- NCT01721096
- Testing
- XIENCE PRIME - Long Length (LL), XIENCE PRIME - Core Size
- Where
- Japan
- Volunteers
- 536 people
- Sponsor
- Abbott Medical Devices
Vascular Disease, Myocardial Ischemia
A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population
The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease…
- Conditions
- Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease
- Trial name
- SV JAPAN (NCT01115933)
- Testing
- XIENCE PRIME SV EECSS
- Where
- 14 sites in Japan
- Volunteers
- 65 people
- Sponsor
- Abbott Medical Devices
Acute Coronary Syndrome, Lipid Disorder
Polypill in Acute Coronary Syndrome
Acute coronary syndromes (ACS) represent a major contributor to mortality, morbidity, and healthcare costs. Effective therapies are widely available; however, adherence is low.
- Conditions
- Acute Coronary Syndrome, Lipid Disorder, Coronary Artery Disease
- Trial name
- POLY-ACS (NCT05514938)
- Testing
- Polypill, Usual Care (individual medications prescribed by primary cardiologist)
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- University of Texas Southwestern Medical Center
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
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
Arterial Occlusive Diseases, Myocardial Ischemia
RESOLUTE Japan SVS: The Clinical Evaluation of the MDT-4107 DES in the Treatment of De Novo Lesions in Small Diameter Native Coronary Arteries
The objective of the study is To verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows the…
- Conditions
- Arterial Occlusive Diseases, Myocardial Ischemia, Cardiovascular Diseases, Coronary Artery Disease
- Trial name
- RJ-SVS (NCT01150500)
- Testing
- MDT-4107 Zotarolimus-Eluting Coronary Stent
- Where
- Japan
- Volunteers
- 65 people
- Sponsor
- Medtronic Vascular
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 Disease
Hybrid Revascularization Observational Study
The purpose of the study is to get a better understanding of patients who have multi-vessel coronary artery disease (blockages in more than one vessel bringing blood to the heart) and have either Hybrid Coronary Revascularization…
- Trial name
- NCT01121263
- Where
- 11 sites in United States
- Volunteers
- 298 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
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
E-Five Registry: A World-Wide Registry With The Endeavor Zotarolimus Eluting Coronary Stent
The safety and efficacy of the Endeavor(TM) ABT-578 Eluting Coronary Stent System has been assessed in a series of studies. The stent is coated with a proprietary drug compound that is designed to reduce restenosis.
- Trial name
- eFive (NCT00623441)
- Testing
- Endeavor Zotarolimus Eluting Coronary Stent
- Volunteers
- 8,314 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Coronary Artery Disease
The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small Vessels
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 SV (NCT01498692)
- Testing
- PROMUS Element Coronary Stent System
- Where
- 23 sites in United States, Australia and 4 more
- Volunteers
- 94 people
- Sponsor
- Boston Scientific Corporation
Peripheral Arterial Disease
Zilver PTX Drug-Eluting Peripheral Stent Study
This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee…
- Trial name
- NCT01348425
- Testing
- Longer Zilver PTX Stents, Shorter Zilver PTX Stents
- Where
- 4 sites in Germany, Switzerland
- Volunteers
- 45 people
- Sponsor
- Cook Group Incorporated
Coronary Artery Disease
First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease
The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent SES.
- Trial name
- DESSOLVE-I (NCT01247428)
- Testing
- MiStent SES
- Where
- 5 sites in Australia, Belgium and 1 more
- Volunteers
- 30 people
- Sponsor
- Micell Technologies
Coronary Heart Disease, Coronary Restenosis
Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents
In a previous randomized comparison oral sirolimus plus bare metal stent compared to bare metal stent implantation alone demonstrated at one year of follow up a significant reduction of angiographic and clinical parameters of…
- Trial name
- ORAR III (NCT00552669)
- Testing
- Oral sirolimus, Drug Eluting stent
- Where
- 3 sites in Argentina
- Volunteers
- 200 people
- Sponsor
- Centro de estudios en Cardiologia Intervencionista
Coronary Arterial Disease (CAD)
Clinical Investigation for Everolimus Drug Eluting Stent
History of Device Development and Study Rationale: Drug-eluting stents (DES) revolutionized percutaneous coronary intervention (PCI) by significantly reducing restenosis and the need for repeat procedures compared to bare-metal…
- Trial name
- EverGreen (NCT06769217)
- Testing
- Drug Eluting Coronary Stent
- Where
- 5 sites in India, Indonesia
- Volunteers
- 888 people
- Sponsor
- Frisch Medical Device Private Limited
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.
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