Clinical trials: Coronary Artery Stenoses
de Novo or Restenosis Lesions
MedJ-01 Ridaforolimus Eluting Coronary Stent System Trial (JNIR)
MedJ-01 Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: A mounted Cobalt Chromium (CoCr) alloy based stent A Rapid Exchange (RX) Coronary System Delivery System A Poly…
- Trial name
- JNIR (NCT02828917)
- Testing
- MedJ-01 Ridaforolimus Eluting Coronary Stent System
- Where
- Japan
- Volunteers
- 104 people
- Sponsor
- Medinol Ltd.
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
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
Coronary Stenosis, Coronary Artery Stenosis
A Study to EXhibit Percutaneous Coronary Artery Dilatation With Non-Slip Element Balloon
The objective of this study is to evaluate safety and effectiveness of the Lacrosse NSE ALPHA coronary dilatation catheter during PCI in subjects with stenotic coronary arteries.
- Conditions
- Coronary Stenosis, Coronary Artery Stenosis, In-stent Restenosis
- Trial name
- EXPANSE-PTCA (NCT04985773)
- Testing
- Lacrosse NSE ALPHA coronary dilatation catheter
- Where
- 10 sites in United States
- Volunteers
- 200 people
- Sponsor
- Infraredx
Coronary Artery Disease, Coronary Stenosis
Physiologic Assessment of Coronary Stenosis Following PCI
This is a pilot study designed to assess the relationship between iFR (instantaneous wave-free ratio) pullback and the distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography (QCA) post…
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Angina, Unstable, Angina, Stable
- Trial name
- DEFINE PCI (NCT03084367)
- Testing
- iFR pullback
- Where
- 28 sites in United States, Netherlands and 1 more
- Volunteers
- 500 people
- Sponsor
- Volcano Corporation
Stenosis
BIONICS Israel Trial
This study aims to assess the device success and the safety of Medinol's Drug Eluting Stent - BioNIR - with a modified delivery system.
- Trial name
- NCT02834806
- Testing
- BioNIR Ridaforolimus Eluting Coronary Stent System
- Where
- Israel
- Volunteers
- 58 people
- Sponsor
- Medinol Ltd.
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
Coronary Artery Disease
Coronary MDCTA With Iopamidol Injection 370
Determine the validity and compare the visualization of arterial segments obtained with 3 doses of iopamidol to determine dose for further investigation in future trials.
- Trial name
- NCT00558792
- Testing
- Isovue 370, 70 mL, Isovue 370, 80 mL, Isovue 370, 90 mL
- Where
- United States
- Volunteers
- 210 people
- Sponsor
- Bracco Diagnostics, Inc
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 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 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
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 Stenosis
Kidney Damage In Patients With Severe Fall In eGFR
This is a pilot study using a randomized, double blinded, comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI).
- Trial name
- NCT01136915
- Testing
- Iopamidol 370, Iodixanol 320
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- Bracco Diagnostics, Inc
Coronary Artery Disease, Coronary Stenosis
ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)
The objective of this prospective, single-blind clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent…
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Atherosclerosis, STEMI
- Trial name
- NCT03507777
- Testing
- Coronary PCI guided by OCT, Coronary PCI guided by Angiography
- Where
- 90 sites in United States, Australia and 18 more
- Volunteers
- 2,487 people
- Sponsor
- Abbott Medical Devices
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
Aortic Stenosis, Coronary Artery Disease
COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis.
Although concomitant coronary artery disease (CAD) is frequent in patients with severe aortic stenosis (AS), hemodynamic assessment of CAD severity in patients undergoing valve replacement for severe AS is challenging.
- Trial name
- COMIC-AS (NCT04420325)
- Where
- 3 sites in Belgium
- Volunteers
- 116 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Coronary Artery Disease, Acute Coronary Syndrome
Tailored Antiplatelet Therapy Following PCI
Clopidogrel is an anti-platelet medication approved by the U.S. Federal Drug Administration (FDA) for use in patients who undergo Percutaneous Coronary Intervention (PCI) with coronary stent implantation.
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome, Stenosis
- Trial name
- TAILOR-PCI (NCT01742117)
- Testing
- Clopidogrel, Ticagrelor
- Where
- 41 sites in United States, Canada and 2 more
- Volunteers
- 5,276 people
- Sponsor
- Mayo Clinic
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
Aortic Valve Disorder, Aortic Valve Insufficiency
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.
- Conditions
- Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure
- Trial name
- NCT01651052
- Testing
- Heart Valve Surgery
- Where
- 2 sites in Poland
- Volunteers
- 133 people
- Sponsor
- Edwards Lifesciences