Clinical trials: Coronary Stenting
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.
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
Optical Frequency Domain Imaging (OFDI) and Vascular Healing After Stent Placement
The use of drug eluting stents (DES) used to treat coronary artery blockages is limited by poor healing of the stented area. This will require the combined use of blood thinners such as aspirin and clopidogrel (i.e.
- Trial name
- OFDI-DM (NCT01794949)
- Testing
- Resolute Integrity stent
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Emory University
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 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 Artery Disease
An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System
The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity…
- Trial name
- RI-US (NCT01638507)
- Testing
- Resolute Integrity Stent
- Where
- United States
- Volunteers
- 230 people
- Sponsor
- Medtronic Vascular
In-Stent Restenosis
PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis
The study will enroll patients with angiographic evidence of in-stent restenosis of a previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter.
- Trial name
- PERVIDEO I (NCT00916279)
- Testing
- Lutonix Paclitaxel-Coated Balloon
- Where
- 8 sites in Belgium, Germany and 1 more
- Volunteers
- 41 people
- Sponsor
- C. R. Bard
Coronary Artery Disease
Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions
The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion restenosis in patients with de novo native coronary artery lesions.
- Trial name
- NCT00232739
- Testing
- CYPHER Sirolimus-eluting Coronary Stent
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Cordis US Corp.
Reperfusion Injury, STEMI
Evaluation of Myocardial Effects of MTP-131 for Reducing Reperfusion Injury in Patients With Acute Coronary Events
The EMBRACE-STEMI trial was a Phase 2a prospective, multicenter, multinational randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and efficacy of IV administered elamipretide (also…
- Trial name
- EMBRACE (NCT01572909)
- Testing
- Bendavia (MTP-131)
- Where
- 30 sites in United States, Germany and 2 more
- Volunteers
- 300 people
- Sponsor
- Stealth BioTherapeutics Inc.
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
Ischemic Heart Disease, Angina Pectoris
XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE PRIME SV Japan PMS)
The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real world practice in Japanese hospitals.
- Conditions
- Ischemic Heart Disease, Angina Pectoris, Coronary Artery Disease, Coronary Artery Occlusion
- Trial name
- NCT02513719
- Testing
- XIENCE PRIME SV Everolimus Eluting Coronary Stent
- Where
- 33 sites in Japan
- Volunteers
- 312 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Observational Registry Study: FIREHAWK DES for Treating Coronary Artery Disease (CAD)
The study aims to further assess the safety, efficacy and the performance of its delivery system of FIREHAWK rapamycin-eluting stent up to five years.
- Trial name
- NCT01412164
- Testing
- FIREHAWK biodegradable polymer rapamycin-eluting stent
- Where
- China
- Volunteers
- 730 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
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
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 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
Chronic Total Occlusion of Coronary Artery, Vascular Disease
XIENCE V® USA Dual Antiplatelet Therapy (DAPT) Cohort
XIENCE V USA is a prospective, multi-center, multi-cohort postapproval study. The objectives of this study are To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and To…
- Conditions
- Chronic Total Occlusion of Coronary Artery, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Trial name
- XVU-AV DAPT (NCT01106534)
- Testing
- clopidogrel + aspirin OR prasugrel + aspirin, XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)
- Where
- 144 sites in United States
- Volunteers
- 870 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Stenosis
Study of BioNIR Drug Eluting Stent System in Coronary Stenosis
The BioNIR study aims to show that the BioNIR ridaforolimus eluting stent is non-inferior to the Resolute zotarolimus-eluting stent for the primary clinical endpoint of target lesion failure (TLF) at 12 months; that it is…
- Trial name
- BIONICS (NCT01995487)
- Testing
- BioNIR, Resolute
- Where
- 8 sites in United States, Belgium and 6 more
- Volunteers
- 1,919 people
- Sponsor
- Medinol Ltd.
Atherosclerosis, Coronary Artery Disease
PROMUS Element Japan Small Vessel Trial
A non-randomized, small vessel (SV) trial at approximately 15 sites in Japan to enroll 60 patients with a de novo lesion ≤28 mm in length (by visual estimate) in a native coronary artery ≥2.25 mm to <2.50 mm in diameter (by…
- Trial name
- NCT01080261
- Testing
- PROMUS Element
- Where
- 15 sites in Japan
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Coronary Artery Stenosis, Coronary Arteriosclerosis
XIENCE V: SPIRIT WOMEN Sub-study
The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female…
- Conditions
- Coronary Artery Stenosis, Coronary Arteriosclerosis, Coronary Artery Disease, Coronary Artery Restenosis
- Trial name
- NCT01182428
- Testing
- XIENCE V®/ XIENCE PRIME™, CYPHER SELECT
- Where
- 25 sites in Argentina, Austria and 13 more
- Volunteers
- 455 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)
XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and To…
- Trial name
- XVU-Phase 1 (NCT00676520)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent
- Where
- United States
- Volunteers
- 8,053 people
- Sponsor
- Abbott Medical Devices