Clinical trials: Coronary Artery Stenosis
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 Disease, Artificial Intelligence
Evaluation on the Effectiveness and Safety of RuiXin-CoronaryAI for Diagnosis of Coronary Artery Stenosis
With the emergence of advanced technology to date in the artificial intelligence (AI), computer aided diagnosis has gradually gained its popularity in the field of healthcare.
- Conditions
- Coronary Artery Disease, Artificial Intelligence, Coronary Artery Stenosis, CT Angiography
- Trial name
- NCT05320185
- Testing
- RuiXin-CoronaryAI software
- Where
- 3 sites in China
- Volunteers
- 615 people
- Sponsor
- Shenzhen Raysight Intelligent Medical Technology Co., Ltd.
Coronary Artery Disease, Coronary Restenosis
Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR
AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded to evaluate two strategies of in stent restenosis treatment: Implantation of drug eluting bioresorbable stent scaffold Absorb® vs.
- Trial name
- AbsorbISR (NCT02474485)
- Testing
- BVS Absorb implantation., DEB Sequent Please inflation., Control coronary angiography.
- Where
- Switzerland
- Volunteers
- 53 people
- Sponsor
- SIS Medical AG
Coronary Artery Stenosis
Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the PTCA NC Catheters Family
The purpose of this post market study is to collect clinical data of the Arthesys PTCA NC catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.
- Trial name
- NCT05536180
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Arthesys
Coronary Artery Disease
MCG Algorithm Optimization Study in Patients With Coronary Artery Stenosis
This prospective, multicenter study aims to optimize the Magnetocardiography (MCG) algorithm for detecting myocardial ischemia in patients with coronary artery stenosis.
- Trial name
- NCT07888465
- Volunteers
- 165 people
- Sponsor
- AMCG
Coronary Stenosis
Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent
The primary objective of this study is to compare the performance of SUPRAFLEX to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease.
- Trial name
- TALENT (NCT02870140)
- Testing
- SUPRAFLEX, XIENCE
- Where
- 23 sites in Bulgaria, Hungary and 5 more
- Volunteers
- 1,435 people
- Sponsor
- ECRI bv
Coronary Artery Stenosis
De Novo Pilot Study, Lutonix Catheter in Conjunction With Bare Metal Stenting for Treatment of Coronary De Novo Lesions
The study will enroll patients with angiographically significant coronary de novo lesions. Subjects will be randomized 1:1 and treated with a Lutonix catheter either before or after bare-metal stenting (BMS).
- Trial name
- NCT00934752
- Testing
- Lutonix Paclitaxel-Coated Balloon
- Where
- 3 sites in Netherlands
- Volunteers
- 24 people
- Sponsor
- C. R. Bard
Coronary Artery Disease, Coronary Stenosis
TARGET-PREMIER Trail in Evaluating the Safety and Efficacy of the Rapamycin Target Eluting Stent in CAS Treatment
The aim of the TARGET PREMIER trail in to demonstrate the safety and efficacy of the rapamycin target eluting stent in the treatment of subjects with ischemic heart disease (asymptomatic myocardial ischemia , table or unstable…
- Trial name
- T-P (NCT04951050)
- Testing
- Rapamycin target eluting stent
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., 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
Coronary Artery Disease, Myocardial Infarction
Clinical Evaluation of Radiation Reduction for Optimized Safety
The primary objective of this study is to determine whether a reduced radiation protocol (RRP) in which angiograms are acquired at ultralow radiation doses and then processed using spatiotemporal enhancement software can produce…
- Conditions
- Coronary Artery Disease, Myocardial Infarction, Coronary Disease, Coronary Stenosis
- Trial name
- CERROS (NCT06348875)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Angiowave Imaging
Left Main Coronary Artery Stenosis
The OPTIMAL Randomized Controlled Trial
The OPTIMAL study is a randomized, controlled, multicentre, international study. A total of 800 patients will be randomized in a 1:1 fashion to Intravascular Ultrasound (IVUS)-guided PCI versus qualitative angio(QCA)-guided…
- Trial name
- OPTIMAL (NCT04111770)
- Testing
- IVUS guided Percutaneous Coronary Intervention, Qualitative or quantitative angiography will guide percutaneous coronary intervention
- Where
- 28 sites in Italy, Spain and 1 more
- Volunteers
- 806 people
- Sponsor
- ECRI bv
Coronary Stenosis, Coronary Artery Disease
IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System
This is a prospective, multi-center, single-arm, open-label, early feasibility study to provide preliminary evidence for the safety and efficacy of the novel IoNIR stent system
- Trial name
- NCT06071702
- Testing
- IoNIR Ridaforolimus-Eluting Coronary Stent System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Medinol Ltd.
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.
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
Myocardial Ischemia, Coronary Artery Stenosis
Safety Study of a Bioresorbable Coronary Stent
To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.
- Conditions
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease
- Trial name
- RESTORE (NCT01262703)
- Testing
- ReZolve Stent
- Where
- Brazil
- Volunteers
- 49 people
- Sponsor
- REVA Medical, Inc.
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
Treatment Of Stenotic Lesions In Native Coronary Arteries.
BioFreedom FIM Clinical Trial.
Prospective, multi center, randomized, single blinded study designed to demonstrate the safety and effectiveness of the Biosensors BioFreedom Drug-Eluting Coronary Stent Delivery System at multiple time points compared to the…
- Trial name
- NCT01172119
- Testing
- Biofreedom Drug Eluting Stent, Tuxus Liberte Drug Eluting Stent
- Where
- 4 sites in Germany
- Volunteers
- 182 people
- Sponsor
- Biosensors Europe SA
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.