Clinical trials: Ischemic Lesions
Stable Angina, Unstable Angina
Drug Coated Balloon Compared to Bare Metal Stent for de Novo Coronary Artery Lesions
This randomized trial will assess the efficacy of Drug Coated Balloon (DCB) compared to Bare Metal Stent (BMS) using Fractional Flow Reserve (FFR) guidance for de novo coronary artery lesions in patients unable to tolerate dual…
- Trial name
- NCT02456402
- Testing
- Drug Coated Balloon, Bare Metal Stent
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Ulsan University Hospital
Myocardial Infarction
Angiography Versus (vs) IVUS Optimisation
The purpose of the study id to demonstrate an advantage for intra-vascular ultrasound (IVUS) optimized drug-eluting stent (DES) implantation compared to angiography in complex lesions
- Trial name
- AVIO (NCT00936169)
- Testing
- IVUS optimised DES implantation, angiographically guided DES implantation
- Volunteers
- 284 people
- Sponsor
- Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Coronary Artery Disease
Rotational Atherectomy for Calcified lEsion By Smart Angioplasty Research Team (SMART-RACE)
Current guidelines recommend the use of rotational atherectomy (RA) for preparation of heavily calcified or severely fibrotic lesions that cannot be crossed by a balloon or adequately dilated before planned stenting (bailout…
- Trial name
- NCT02716363
- Testing
- Rotational Atherectomy by Rotablator
- Where
- South Korea
- Volunteers
- 500 people
- Sponsor
- Samsung Medical Center
Coronary Artery Disease, Diabetes Mellitus
PROVIDENCE:Prevention of Restenosis With Oral Rosiglitazone and the Vision Stent in Diabetics With Coronary Lesions
We hypothesize that the combination of the thin-strut MULTI-LINK (i.e. VISION(tm) and/or MINI-VISION(tm)) stent and pharmacologic therapy with the oral PPAR-gamma agonist rosiglitazone will significantly reduce restenosis after…
- Trial name
- NCT00116792
- Testing
- Percutaneous Coronary Intervention (PCI)
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Gold, Herman K., MD
Systemic Sclerosis
Open-Label Study of Oral Treprostinil in Digital Ulcers
This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects…
- Trial name
- DISTOL-EXT (NCT00848107)
- Testing
- treprostinil diethanolamine
- Where
- 26 sites in United States, Canada and 1 more
- Volunteers
- 115 people
- Sponsor
- United Therapeutics
Angina Pectoris, Angina, Unstable
Intravascular Near Infrared Spectroscopy (NIRS) Bifurcation - Lipid Core Plaque Shift Study
This pilot study is going to examine the hypothesis that in coronary arteries, soft lesions that contain lipid cores, but are not calcified or fibrotic and are located in proximity to side branches, are associated with side…
- Conditions
- Angina Pectoris, Angina, Unstable, Atherosclerosis, Coronary Artery Disease
- Trial name
- NCT00905671
- Testing
- LipiScan Coronary Imaging Catheter
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Infraredx
Coronary Artery Disease (CAD), Calcific Coronary Arteriosclerosis
Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions: the OROBICA Registry.
The OROBICA (Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions) Registry is a multicenter, ambispective, real-world observational study designed to evaluate clinical, procedural…
- Conditions
- Coronary Artery Disease (CAD), Calcific Coronary Arteriosclerosis, Intravascular Lithotripsy; Rotational Atherectomy; OFDI, Orbital Atherectomy
- Trial name
- OROBICA (NCT07566403)
- Testing
- Percutaneous coronary intervention with or without stent implantation
- Where
- Italy
- Volunteers
- 3,000 people
- Sponsor
- Papa Giovanni XXIII Hospital
Ischemic Heart Disease, Coronary Artery Stenosis
A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions
This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention…
- Conditions
- Ischemic Heart Disease, Coronary Artery Stenosis, Chronic Coronary Total Occlusion, Coronary Bypass Graft Stenosis
- Trial name
- CROSS (NCT01186198)
- Testing
- MINI TREK RX 1.20 mm Coronary Dilatation Catheter
- Where
- 4 sites in United States
- Volunteers
- 71 people
- Sponsor
- Abbott Medical Devices
Coronary Disease
Paclitaxel Eluting Balloon Catheter in Coronary De-novo Lesions Treatment in China
The aim of this Real-world study in China is evaluating the Safety and Efficacy of Paclitaxel Eluting Balloon Catheter in Coronary de-novo lesions(target vessel diameter:2.5mm-4.0mm)Treatment.
- Trial name
- RESPECT (NCT03466749)
- Testing
- Paclitaxel Eluting Balloon Catheter
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Xijing Hospital
Myocardial Infarction
The Influence of Glycaemia and Insulinemia on Vasomotor Endothelial Function After Myocardial Infarction
The objective of this study is to investigative the influence of different levels of glycaemia or insulinemia in vascular endothelium in ischemia/reperfusion lesion after myocardial infarction
- Trial name
- INGLIVEF (NCT02250989)
- Where
- Brazil
- Volunteers
- 75 people
- Sponsor
- University of Campinas, Brazil
Coronary Artery Disease
A Study of Drug Coated Balloon For Treating the Side Branch in Complex Bifurcation Lesions
Hypothesis: In patients undergoing coronary stenting for the true bifurcation lesions, main branch stenting followed by side branch dilatation with drug coated balloon is superior to the provisional-stenting strategy in terms of…
- Trial name
- STENT-FREE (NCT05222061)
- Testing
- Drug coated balloon for the side brunch, Conventional balloon for the side brunch
- Where
- Russia
- Volunteers
- 80 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
Myocardial Ischemia(Implanted Drug-eluting Stents Because of Ischemic Heart Disease(Stable Angina, Acute Coronary Syndrome))
Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions (IVUS-XPL Study): Retrospective and Prospective Follow-up Study
The investigator aimed to evaluate the long-term (up to 10 years) follow-up of the patients who enrolled the IVUS-XPL study (Impact of IntraVascular UltraSound Guidance on the Outcomes of Xience Prime Stents in Long Lesions)…
- Trial name
- NCT03866486
- Where
- South Korea
- Volunteers
- 1,400 people
- Sponsor
- Yonsei University
Drug-Coated Balloon, De Novo Stenosis
Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS)
The DCB-ACS trial is a prospective, multi-center, non-inferiority, randomized controlled trail. The purpose of this trial is to evaluate the safety and efficacy of drug-coated balloon(DCB) in de novo lesions for acute coronary…
- Conditions
- Drug-Coated Balloon, De Novo Stenosis, Acute Coronary Syndromes, ACS
- Trial name
- DCB-ACS (NCT04937803)
- Testing
- Drug-coated balloon, Zotarolimus-Eluting Coronary Stent
- Where
- China
- Volunteers
- 216 people
- Sponsor
- Harbin Medical University
Coronary Artery Disease, Coronary Disease
Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
Clinical research with medical devices indicated in accordance with the CE marking, led by researchers, multicenter, open, prospective, randomized and controlled.
- Trial name
- OraBil (NCT06736899)
- Testing
- Orbital Atherectomy System Treatment, Balloon System Treatment
- Where
- 9 sites in Spain
- Volunteers
- 200 people
- Sponsor
- Fundación EPIC
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
In-Stent Coronary Artery Restenosis, Coronary Artery Disease
The PICCOLETO XI A-PREP Study
To compare the angiographic and clinical outcomes of aggressive versus standard balloon preparation during drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR).
- Trial name
- PICCOLETO-XI (NCT07391033)
- Volunteers
- 500 people
- Sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
Coronary Artery Disease
The SELUTION DeNovo Study
A Prospective Randomized, Multi-centre, International, Open Label, Clinical trial comparing the Selution DEB strategy versus DES strategy.
- Trial name
- NCT04859985
- Testing
- SELUTION SLR, DES
- Where
- 62 sites in Austria, Czechia and 10 more
- Volunteers
- 3,326 people
- Sponsor
- M.A. Med Alliance S.A.
ST Elevation Myocardial Infarction, Non-ST Elevation Myocardial Infarction
IVUS Versus FFR for Non-infarct Related Artery Lesions in Patients With Multivessel Disease and Acute MI
The aim of the study is to compare clinical outcomes between intravascular ultrasound (IVUS)-guided treatment decision versus fractional flow reserve (FFR)-guided treatment decision for non-infarct related artery stenosis in…
- Trial name
- FRAME-AMI2 (NCT05812963)
- Testing
- IVUS-guided PCI group, FFR-guided PCI group
- Where
- 2 sites in South Korea
- Volunteers
- 1,400 people
- Sponsor
- Samsung Medical Center
Internal Carotid Stenosis
Medico-economic Evaluation of Preoperative Cerebral Oximetry Monitoring During Carotid Endarterectomy
In France, in 2007, 17 000 patients underwent carotid endarterectomy. The risk of having an ipsilateral postoperative stroke after carotid endarterectomy remains at 1-1.5%.
- Trial name
- EMOCAR (NCT01415648)
- Testing
- cerebral oximetry monitoring using INVOS™ and hemodynamic optimisation, standard cerebral monitoring and hemodynamic optimisation
- Where
- 19 sites in France
- Volunteers
- 879 people
- Sponsor
- Nantes University Hospital
Coronary Artery Disease, Diabete Type 2
DCB for CAD With Type 2 Diabetes
Patients with coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) often present with diffuse, complex lesions and a higher risk of in-stent restenosis after PCI.
- Trial name
- DCBinT2DM (NCT07009938)
- Testing
- Drug-Coated Balloon (DCB), Drug-Eluting Stent (DES) implantation
- Where
- 6 sites in China
- Volunteers
- 1,000 people
- Sponsor
- Shanghai 10th People's Hospital