Clinical trials: Ischemic Lesions
Coronary Arteriosclerosis
Multicenter Postmarket Surveillance Registry Evaluating Performance and Long Term Safety of the Presillion Stent
The purpose of this study is: To evaluate the safety and performance of the Presillion stent in routine clinical practice.
- Trial name
- NCT00968019
- Testing
- Presillion stent
- Where
- 13 sites in Portugal, Spain
- Volunteers
- 318 people
- Sponsor
- Johnson and Johnson, S.A.
Coronary Artery Disease
Serial Changes After Drug-Coated Balloon
The study aims at evaluating the morphological changes of plaque estimated by optical coherence tomography (OCT) and Factors Influencing Plaque Healing after Drug-Coated Balloon (DCB) for de Novo Coronary Lesions.
- Trial name
- HEAL-aDCB (NCT04636931)
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Affiliated Hospital of Dalian Medical University
Acute Coronary Syndrome, STEMI - ST Elevation Myocardial Infarction
SOLVE-ACS: Bioresorbable Magnesium-Stents Magmaris in ACS Lesions
The aim of the registry is to investigate the clinical performance of the Magmaris Magnesium Stent in STE-ACS and NSTE-ACS patients.
- Conditions
- Acute Coronary Syndrome, STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI
- Trial name
- SOLVE-ACS (NCT03773081)
- Testing
- Implantation of the Magmaris scaffold
- Where
- 4 sites in Germany
- Volunteers
- 11 people
- Sponsor
- Charite University, Berlin, Germany
Coronary Artery Disease, Acute Coronary Syndromes (ACS)
DECisive Intracoronary PHysiology and Imaging in the Evaluation and Reclassification of Non-culprit Lesions in Acute Coronary Syndrome
Despite all advances in diagnostic and therapeutic methods over the past century, ischemic heart disease (IHD) remains a leading cause of mortality and morbidity worldwide.
- Conditions
- Coronary Artery Disease, Acute Coronary Syndromes (ACS), Optic Coherence Tomography, Fractional Flow Reserve
- Trial name
- DECIPHER (NCT07548554)
- Testing
- Intracoronary Physiology, Intracoronary imaging
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Coronary Restenosis
Effect of Combination of Non-sLip Element Balloon (NSE) and druG-coated bAlloon (DCB) for In-steNT Restenosis Lesions
Use of SeQuent® Please drug coated balloon (DCB) is effective to treat patients with in-stent restenosis (ISR). However, whether the type of pre-dilatation balloon prior to DCB dilatation impacts on clinical and angiographic…
- Trial name
- ELEGANT (NCT02300454)
- Testing
- Non-slip element balloon (NSE), Balloon
- Where
- 2 sites in Japan
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Mitsui Memorial Hospital
Ischemic Heart Disease, Stenotic Coronary Lesion
RESOLUTE ONYX China RCT Study
It is a randomized controlled trial to evaluate the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in comparison with the Medtronic Resolute Integrity™ Zotarolimus-Eluting coronary…
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis
- Trial name
- NCT03466151
- Testing
- Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
- Where
- 2 sites in China
- Volunteers
- 550 people
- Sponsor
- Medtronic Vascular
ST Segment Elevation Myocardial Infarction (STEMI)
Evaluating the Safety and Efficacy of Drug-Coated Autoperfusion Balloons Versus Conventional Drug-Coated Balloons Guided by IVUS-OCT Multimodal Imaging for Treating Acute Myocardial Infarction: OPERA-AMI Study
Trial Goals: 1. Evaluation of Mid- to Long-Term Safety and Effectiveness of Drug-Coated Autoperfusion Balloon Dilatation Catheter (DCAB) versus Conventional Drug coated balloon (DCB) in Patients with ST Segment Elevation…
- Trial name
- NCT06794801
- Testing
- Drug Coated Autoperfusion Balloon Dilatation Catheter（DCAB）, Conventional Drug coated balloon (DCB)
- Where
- China
- Volunteers
- 134 people
- Sponsor
- LanZhou University
Perinatal Stroke
Baby Brain Recovery Study
This study will be a longitudinal multiple-visit observational study, done to identify possible bioindicators of recovery and repair of motor corticospinal pathways which may be targeted by future interventions in infants with…
- Trial name
- NCT05013736
- Testing
- Magnetic Resonance Imaging, Behavioral Assessments, Non invasive Transcranial Magnetic Stimulation
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- University of Wisconsin, Madison
Peripheral Arterial Disease
HORIZON Prospective Clinical Investigation
The objective of this clinical investigation is to demonstrate and provide long term clinical data on safety and performance of the Exist 6F NiTi stent system type FLEX \& PULL in a prospective investigation for the treatment of…
- Trial name
- NCT05234164
- Testing
- EXIST 6F NiTi Stent System FLEX, EXIST 6F NiTi Stent System PULL
- Where
- 2 sites in Italy, Poland
- Volunteers
- 69 people
- Sponsor
- Qmedics AG
Coronary Artery Disease
Aortic Stiffness and Distensibility as Predictor to Severity of Coronary Artery Disease
Assess the relationship of Aortic root distensibility and stiffness with the extent of coronary artery disease as assessed by SYNTAX score compared to a matched cohort of patients with normal coronary angiography
- Trial name
- NCT03615963
- Testing
- echocardiography and coronary angiography
- Where
- Egypt
- Volunteers
- 150 people
- Sponsor
- Assiut University
Ischemic Heart Disease, Coronary Artery Disease
StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation
The objective of this study is to evaluate the rate of SYNERGY 48 mm stent strut coverage and assess neointimal progression via OCT measurement in patients who underwent PCI.
- Conditions
- Ischemic Heart Disease, Coronary Artery Disease, Coronary Atherosclerosis
- Trial name
- NCT03401216
- Testing
- SYNERGY 48 mm, PCI, 3 month OCT follow-up
- Where
- Russia
- Volunteers
- 80 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Coronary Artery Disease
Baseline V-RESOLVE Score Guided Versus Angiography Guided Stent Implantation in Coronary Bifurcation Lesions (CIT-RESOLVE II)
The purpose of this study is to investigate whether baseline V-RESOLVE score guided intervention is associated with significant reduction of side branch occlusion rates compared to angiography guided intervention in patients with…
- Trial name
- NCT05503407
- Testing
- Baseline V-RESOLVE score-guided PCI, Angiography-guided PCI
- Where
- China
- Volunteers
- 1,104 people
- Sponsor
- China National Center for Cardiovascular Diseases
Cardiovascular Disease, Coronary Artery Occlusion
Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients
The NAGOMI COMPLEX PMCF (Post-Market Clinical Follow-up) study has been designed to expand the knowledge about outcomes with the Ultimaster Nagomi™ sirolimus eluting coronary stent system (Ultimaster Nagomi™) in complex PCI…
- Conditions
- Cardiovascular Disease, Coronary Artery Occlusion, Ischemic Heart Disease
- Trial name
- NAGOMI COMPLEX (NCT05705973)
- Testing
- Ultimaster Nagomi™
- Where
- 52 sites in Austria, Belgium and 11 more
- Volunteers
- 3,000 people
- Sponsor
- Terumo Europe N.V.
Critical Limb Ischemia
Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy.
To evaluate the safety and effectiveness of the Spur System in a patient population with infrapopliteal artery disease (tibioperoneal, anterior/posterior tibial and peritoneal arteries) when used in conjunction with…
- Trial name
- DEEPER (NCT03669458)
- Testing
- Below the Knee peripheral intervention
- Where
- Dominican Republic
- Volunteers
- 21 people
- Sponsor
- ReFlow Medical, Inc.
Stable Coronary Artery Disease, Silent Myocardial Ischemia
Prospective Study to Assess DES Re-endothelization in BMS Restenosis and De-novo Lesions
The hypothesis of this study is that strut coverage occurs earlier when a DES is implanted to treat a BMS restenosis compared with atherosclerotic de-novo lesion.
- Conditions
- Stable Coronary Artery Disease, Silent Myocardial Ischemia, In-stent(BMS)Restenosis, De-novo, Atherosclerotic, Coronary Lesions
- Trial name
- DESERT (NCT01243099)
- Where
- Italy
- Volunteers
- 31 people
- Sponsor
- S.M. Misericordia Hospital
Coronary Occlusion
Cohort B of the Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter
A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary…
- Trial name
- NCT03719014
- Testing
- NovaCross
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Nitiloop Ltd.
Coronary Artery Disease, Coronary Stenosis
Z-SEA-SIDE: Sirolimus Versus Everolimus Versus Zotarolimus-eluting Stent Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-branch Stenosis
BACKGROUND: Bifurcated lesions are a challenging subset in percutaneous coronary interventions (PCI). The selection of the type of drug-eluting stents (DES) and the technique for stent implantation have not been clarified.
- Trial name
- Z-SEA-SIDE (NCT01200693)
- Testing
- Sirolimus eluting stent, Everolimus eluting stent, Zotarolimus eluting stent
- Where
- Italy
- Volunteers
- 80 people
- Sponsor
- Catholic University of the Sacred Heart
Coronary Artery Disease
Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)
There is no definite conclusive work about the benefit of OCT-guided PCI, which should be determined in complex PCI, assuming better stent optimization by OCT.
- Trial name
- NCT03625908
- Testing
- OCT-guided PCI, Angiography-guided PCI
- Where
- South Korea
- Volunteers
- 1,604 people
- Sponsor
- Yonsei University
Coronary Artery Disease
Safety and Efficacy of the CRE8 Stent for the Treatment of De Novo Coronary Artery Lesions
The purpose of this study is to evaluate the safety, efficacy and deliverability of the CRE8 sirolimus-eluting stent and the RESOLUTE zotarolimus-eluting stent in the treatment of patients with de novo coronary artery lesions.
- Trial name
- NCT02360423
- Testing
- CRE8 sirolimus-eluting stent, RESOLUTE zotarolimus-eluting stent
- Where
- China
- Volunteers
- 430 people
- Sponsor
- CID S.p.A.
Acute Myocardial Infarction, Restenoses, Coronary
Abbott Vascular Medical Device Registry
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use…
- Conditions
- Acute Myocardial Infarction, Restenoses, Coronary, Coronary Artery Lesions, Venous Embolism
- Trial name
- AV-MDR (NCT04573660)
- Testing
- Coronary and peripheral stents, Pacing catheters, Vascular plugs
- Where
- 37 sites in United States, Australia and 12 more
- Volunteers
- 3,784 people
- Sponsor
- Abbott Medical Devices