Clinical trials: Ischemic Lesions
Coronary Disease
OCT Measures Predicting FFR
Background: the decision-making process of patients with angiographically-intermediate coronary lesions (ICL) is clinically challenging and may benefit from adjunctive invasive techniques.
- Trial name
- OMEF (NCT03573388)
- Testing
- Optical coherence tomography (OCT)
- Where
- Italy
- Volunteers
- 500 people
- Sponsor
- Catholic University of the Sacred Heart
Acute Ischemic Stroke, Transient Ischemic Attack
Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke
The goal of this observational study is to to investigate the prevalence and time course of autonomic dysfunction in acute ischemic stroke patients; to evaluate the influence of lesion location on autonomic dysfunction; to…
- Trial name
- ARIADNE (NCT06740942)
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
Coronary Artery Disease
Comparison of a Contemporary Sirolimus-eluting Stent (ihtDEStiny®) With Another Everolimus-eluting Stent (Xience™), Both With Permanent Polymers, in Patients With Acute Coronary Syndrome and de Novo Coronary Artery Lesions
To evaluate the efficacy of the two DES (Drug Eluting Stent) used in terms of device-related adverse events at 12 months after PCI (Percutaneous Coronary Intervention).
- Trial name
- DestinACSion (NCT07190690)
- Testing
- ihtDEStiny® DES implanted, Xience™ DES implanted
- Where
- 20 sites in Spain
- Volunteers
- 2,100 people
- Sponsor
- Fundación EPIC
Coronary Artery Disease
Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)
The objective of this study is to assess the performance and safety of two reduced sirolimus doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX) Stent Delivery System (SDS) in patients…
- Trial name
- NCT00233766
- Testing
- Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose
- Where
- Brazil
- Volunteers
- 60 people
- Sponsor
- Cordis US Corp.
Coronary Disease
Keep bIfurcation Single Stenting Simple
KISS study is an investigator-initiated, multi-centre, prospective, randomized (1:1), parallel, two-arm, non-inferiority trial aiming to compare two bifurcation PCI procedures for Side Branch protection
- Trial name
- KISS (NCT04285372)
- Testing
- Side branch protection/ballooning, No side branch protection/ballooning
- Where
- 20 sites in France, Italy and 4 more
- Volunteers
- 596 people
- Sponsor
- Ceric Sàrl
Atherosclerosis, Ischemia Limb
Efficacy and Safety Comparison of the Open Surgical and Endovascular Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type D.
Endovascular revascularization and open bypass grafting above the knee show comparable results in primary 2-year patency (about 65%) in medium-length lesions - TASC II, C (Pereira et al, 2006).
- Conditions
- Atherosclerosis, Ischemia Limb, Superficial Femoral Artery Occlusion, Popliteal Artery Occlusion
- Trial name
- NCT04588571
- Testing
- Endovascular recanalization with angioplasty and stenting with the biomimetic interwoven nitinol stent, Femoropopliteal proximal bypass
- Where
- Russia
- Volunteers
- 110 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Coronary Artery Disease, Coronary Artery Disease Progression
Critical Treatment of Coronary Artery Disease
Identifying the critical lesion of coronary artery disease and determining the interventional plan are significant for reducing adverse cardiovascular adverse events.
- Trial name
- CTCAD (NCT03195621)
- Testing
- Stent implantation
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Southeast University, China
Coronary Artery Disease
Quantification of Myocardial Blood Flow Using Dynamic PET/CTA Fused Imagery
This observational prospective clinical study is to develop software tools to fuse coronary anatomy data obtained from CT coronary angiography with dynamic PET data to noninvasively measure absolute myocardial blood flow, flow…
- Trial name
- NCT04221594
- Testing
- Invasive Cardiac Catheterization (ICA), Coronary Computed Tomographic Angiogram (CCTA), Dynamic Cardiac Positron Emission Tomography (dPET)
- Where
- 6 sites in United States, South Korea
- Volunteers
- 68 people
- Sponsor
- Emory University
Coronary Artery Disease
Clinical and Angiographic Outcomes of Post-drug-coated Balloon Angioplasty in Native Coronary Lesions
The progression of cardiac revascularization techniques, starting with standard balloon angioplasty (POBA) and progressing to the creation of drug-coated balloons (DCB) and drug-eluting stents (DES).
- Trial name
- NCT06340373
- Testing
- DCB Angioplasty
- Where
- Bangladesh
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- National Institute of Cardiovascular Diseases, Bangladesh
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 Disease
BIOSOLVE-IV Magmaris Swiss Satellite Registry
BIOSOLVE-IV Magmaris Swiss Satellite Registry is a prospective, single-arm, multicenter, nationwide open label registry. It is planned to enroll 200 subjects in up to 12 participating sites in Switzerland.
- Trial name
- NCT04025788
- Testing
- Magmaris Resorbable Magnesium Scaffold (RMS)
- Where
- 6 sites in Switzerland
- Volunteers
- 10 people
- Sponsor
- University Hospital, Geneva
Coronary Artery Disease
A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter
The objective of the PINNACLE I Clinical Study is to assess safety and performance of the LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX) to treat moderately to severely…
- Trial name
- PINNACLE-I (NCT05828173)
- Testing
- LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX)
- Where
- 7 sites in Belgium, Netherlands
- Volunteers
- 60 people
- Sponsor
- Elixir Medical Corporation
Atherosclerotic Heart Disease
Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent
In this prospective study, a newly developed self-expanding nitinol stent is evaluated for the treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery.
- Trial name
- NCT01816854
- Testing
- Stenting
- Where
- Belgium
- Volunteers
- 117 people
- Sponsor
- be Medical
Ischemic Heart Failure, CABG-patients
hiPSC-CMs-loaded Chitosan Patch to Treat Severe Chronic Ischemic Heart Disease
This is an exploratory study. A total of 16 patients meeting the inclusion and exclusion criteria and awaiting coronary artery bypass grafting (CABG) surgery will be enrolled.
- Trial name
- NCT07471698
- Testing
- HiCM-188 Chitosan Patch, Blank Chitosan Patch
- Where
- China
- Volunteers
- 16 people
- Sponsor
- HELP Therapeutics Co., Ltd.
Stable Angina, Unstable Angina
Assessment of Diagonal Branch Territory
This study was performed to investigate the anatomical attributes that determine myocardial territory of diagonal branches and to develop a prediction model for clinically relevant branches using myocardial perfusion imaging…
- Trial name
- NCT03935542
- Where
- South Korea
- Volunteers
- 355 people
- Sponsor
- Bon-Kwon Koo
Coronary Artery Disease
Conservative Versus Aggressive Revascularization in Patients With Intermediate Lesions Undergoing Percutaneous Coronary Intervention With Angiography Guidance Alone
The aim of this study was to compare conservative versus aggressive strategy in patients with intermediate lesions with angiography guidance alone.
- Trial name
- SMART-CASE (NCT00743899)
- Testing
- The aggressive group, The conservative group
- Where
- South Korea
- Volunteers
- 899 people
- Sponsor
- Samsung Medical Center
Coronary Artery Disease
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
This study is designed to investigate whether drug-coated balloon (DCB) compared to conventional balloon angioplasty for side branch after provisional stenting will lead to lower rates of the composite endpoint of major adverse…
- Trial name
- DCB-BIF (NCT04242134)
- Testing
- Drug-coating balloon
- Where
- China
- Volunteers
- 784 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
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.
Acute Coronary Syndrome
Peripheral Vascular Disease and Coronary Artery Disease
This study aims at evaluating the relationship between peripheral artery plaque characteristics evaluated by ultrasound and coronary culprit lesion characteristics evaluated by OCT in ACS patients.
- Trial name
- NCT03971864
- Where
- China
- Volunteers
- 350 people
- Sponsor
- Harbin Medical University
Atherosclerosis, Heart Diseases, Coronary
A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)
EVOLVE 4.5/5.0 is a prospective, single-arm, multi-center observational (standard of care) trial intended to confirm the safety and effectiveness of the SYNERGY 4.50 mm and 5.00 mm Coronary Stent System for the treatment of…
- Conditions
- Atherosclerosis, Heart Diseases, Coronary, Coronary Artery Disease, Cardiovascular Diseases
- Trial name
- NCT03875651
- Testing
- SYNERGY 4.50 mm and 5.0 mm Coronary Stent System
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Boston Scientific Corporation