Clinical trials: Restenoses, Coronary
Coronary Restenosis
Trial of a Novel Paclitaxel-coated Balloon With Citrate Excipient for Restenosis in -Limus Analogue DES
Hypothesis: Angioplasty with a novel paclitaxel-coated balloon (PCB; Agent, Boston Scientific) with citrate-based excipient will be non-inferior to conventional paclitaxel-coated balloon with iopromide excipient (PCB) for the…
- Trial name
- ISAR-DESIRE 3A (NCT02367495)
- Testing
- PCB
- Where
- Germany
- Volunteers
- 125 people
- Sponsor
- Deutsches Herzzentrum Muenchen
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
Chronic Coronary Occlusion, Vascular Disease
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)
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…
- Conditions
- Chronic Coronary Occlusion, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Trial name
- XVU-LTF (NCT01120379)
- Testing
- XIENCE V® EECSS
- Where
- United States
- Volunteers
- 5,034 people
- Sponsor
- Abbott Medical Devices
Percutaneous Coronary Intervention, Optical Coherence Tomography
SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
BACKGROUD: Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis. Protected LM PCI is considered standard of care in most centers.
- Conditions
- Percutaneous Coronary Intervention, Optical Coherence Tomography, In-stent Coronary Artery Restenosis
- Trial name
- SOLEMN (NCT03474432)
- Testing
- Optical Coherence Tomography
- Where
- 13 sites in United States
- Volunteers
- 12 people
- Sponsor
- Jesse Brown VA Medical Center
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
Chronic Coronary Occlusion, Left Main Coronary Artery Disease
EXCEL Clinical Trial (Universal Registry)
The purpose of the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized…
- Conditions
- Chronic Coronary Occlusion, Left Main Coronary Artery Disease, Stent Thrombosis, Vascular Disease
- Trial name
- EXCEL (NCT01205789)
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Abbott Medical Devices
Angioplasty, Transluminal, Percutaneous Coronary, Coronary Restenosis
Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial
To evaluate the effect of celecoxib use for 3 month after drug-eluting stent implantation on restenosis on clinical outcome such as target lesion revascularization, thrombotic event, myocardial infarction, death on inflammatory…
- Trial name
- mini-COREA (NCT00500279)
- Testing
- Celecoxib
- Where
- 2 sites in South Korea
- Volunteers
- 900 people
- Sponsor
- Seoul National University Hospital
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
Coronary Restenosis
Treatment of In-Stent Restenosis 2 Study
The aim of this study is to compare the efficacy of sirolimus-eluting balloon catheters (SEB) and iopromide-coated paclutaxel-eluting balloon catheters (PEB) in the treatment of bare metal (BMS) - or drug-eluting stents…
- Trial name
- TIS2 (NCT03667313)
- Testing
- sirolimus-eluting balloon (SEB) MagicTouch, paclitaxel-eluting balloon (PEB) Sequent Please
- Where
- Czechia
- Volunteers
- 200 people
- Sponsor
- University Hospital Ostrava
Acute Coronary Syndrome, Angina Pectoris
DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population
The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on DES performance.
- Conditions
- Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Myocardial Infarction
- Trial name
- DUTCH PEERS (NCT01331707)
- Testing
- Resolute Integrity (Zotarolimus-eluting stent), Promus Element (Everolimus-eluting stent)
- Where
- 4 sites in Netherlands
- Volunteers
- 1,811 people
- Sponsor
- Foundation of Cardiovascular Research and Education Enschede
Chronic Coronary Occlusion, Unprotected Left Main Coronary Artery Disease
EXCEL Clinical Trial
To establish the safety and efficacy of the commercially approved XIENCE Family Stent System (inclusive of XIENCE PRIME, XIENCE V, XIENCE Xpedition and XIENCE PRO [for use outside the United States [OUS] only]) in subjects with…
- Conditions
- Chronic Coronary Occlusion, Unprotected Left Main Coronary Artery Disease, Stent Thrombosis, Vascular Disease
- Trial name
- EXCEL (NCT01205776)
- Testing
- Percutaneous Coronary Intervention, CABG
- Where
- United States
- Volunteers
- 1,905 people
- Sponsor
- Abbott Medical Devices
Angioplasty, Cardiovascular Disease
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011.
- Conditions
- Angioplasty, Cardiovascular Disease, Coronary Artery Disease, Coronary Heart Disease
- Trial name
- XP China SAS (NCT01894152)
- Testing
- XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
- Where
- United States
- Volunteers
- 2,002 people
- Sponsor
- Abbott Medical Devices
Coronary Occlusion, Coronary Stenosis
STAR and Deferred Stenting Study
STAR is a minimal-risk pragmatic clinical trial of patients admitted for a CTO-PCI procedure. The overall objective of the STAR Study is to address the current gaps in knowledge regarding use of STAR during CTO-PCI, as a…
- Conditions
- Coronary Occlusion, Coronary Stenosis, Coronary Restenosis
- Trial name
- STAR (NCT05089864)
- Testing
- Stent Placement Timing - Early, Stent Placement Timing - Late
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Saint Luke's Health System
Coronary Restenosis
Compare the Efficacy and Safety of RESTORE DEB and SeQuent® Please in Chinese Patient With Coronary In-stent Restenosis
The purpose of this study is to evaluate the safety and efficacy of Paclitaxel drug eluting balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment and maintaining the vessels unobstructed in…
- Trial name
- NCT02944890
- Testing
- Drug Eluting Balloon Catheters(RESTORE DEB）, Drug Eluting Balloon Catheters(SeQuent® Please）
- Where
- 14 sites in China
- Volunteers
- 242 people
- Sponsor
- ZhuHai Cardionovum Medical Device Co., Ltd.
Coronary Restenosis
Oral Sirolimus for In-Stent Restenosis
Despite recent advances in interventional cardiology including the success of drug-eluting stents in de-novo coronary lesions, the treatment of in-stent restenosis remains a challenging clinical issue.
- Trial name
- OSIRIS (NCT00859183)
- Testing
- Sirolimus
- Where
- 3 sites in Germany
- Volunteers
- 300 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Coronary Restenosis
The Effects of Bindarit in Preventing Stent Restenosis
The main study objective is to assess the efficacy and safety of different bindarit dosages compared to placebo in preventing restenosis, in patients submitted to coronary stenting and using a bare metal stent (Vision BMS, by…
- Trial name
- NCT01269242
- Testing
- bindarit
- Where
- Italy
- Volunteers
- 148 people
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
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 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
Coronary Artery Disease, Coronary Restenosis
Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation
The purpose of the present study is to provide the first in-human safety and efficacy evaluations of systemic oral anti-proliferative Everolimus therapy compared to placebo in patients treated by bare metal stents for significant…
- Trial name
- NCT00426049
- Testing
- Everolimus
- Where
- Germany
- Volunteers
- 484 people
- Sponsor
- German Heart Institute
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