HARMONEE - Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo...
Coronary ArteriosclerosisNon ST Segment Elevation Acute Coronary SyndromeThis is a multi-center, single-blind, randomized, active-controlled, clinical trial in Percutaneous Coronary Intervention (PCI) subjects. Subjects will be randomized to receive the Combo stent as the investigational treatment arm or an Everolimus Eluting Stent (EES) as the active-control arm.
PAC-IC-SAOS Obstructive Sleep Apnea Syndrome and Ventricular Function
Heart FailureArteriosclerosis of Coronary Artery Bypass Graft or Other Coronary Reperfusion2 moreThe aim of this clinical trial is to evaluate the effect of obstructive sleep apnea syndrome (OSAS) treatment in heart failure patients following coronary artery bypass graft (CABG) surgery or other coronary reperfusion.
BIOLUX P-II First-in-Man Study to Compare the Passeo-18 Lux DRB Against POBA in Infrapopliteal Arteries...
AtherosclerosisArteriosclerosis2 moreA prospective, multicentric, randomized controlled trial to assess the safety and performance of the Passeo-18 Lux Paclitaxel releasing PTA balloon catheter versus the uncoated Passeo 18 PTA balloon catheter for the treatment of stenosis, restenosis or occlusion of the infrapopliteal arteries.
Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic...
ArteriosclerosisCoronary Artery Disease2 moreCrossBoss First is a single-blind randomized controlled trial that will randomize 246 patients undergoing clinically-indicated Chronic Total Occlusion Percutaneous Coronary Intervention, to upfront use of the CrossBoss catheter vs. antegrade guidewire escalation strategy The "CrossBoss First" study has two primary objectives. The primary efficacy objective is to compare the procedure time required to cross the CTO or abort the procedure with a CrossBoss first vs. antegrade wire escalation strategy. The investigators hypothesize that upfront use of the CrossBoss catheter will be associated with shorter procedure time required for CTO crossing compared with an antegrade wire escalation strategy. The primary safety objective is to compare the frequency of procedural major adverse cardiovascular events (MACE) with upfront use of CrossBoss vs. a guidewire escalation strategy. The investigators hypothesize that upfront use of the CrossBoss catheter will be associated with similar incidence of MACE compared with an antegrade wire escalation strategy. The secondary endpoints are: (1) technical and procedural success4-6; (2) total procedure time (defined as the interval between administration of local anesthesia for obtaining vascular access and removal of the last catheter); (3) fluoroscopy time to cross the CTO and total fluoroscopy time; (4) total air kerma radiation exposure; (5) total contrast volume; and (6) number of wires, microcatheters, balloons, and stents used.
The Copenhagen Insulin and Metformin Therapy Trial
Type 2 DiabetesAtherosclerosis1 moreType 2 Diabetes Mellitus patients (T2DM) have an increased mortality rate due to macrovascular disease. The primary objective of the study is to evaluate the effect of an 18-month treatment with metformin versus placebo in combination with one of three insulin analogue regimens following a treat-to-target principle. The primary outcome measure is change in wall thickness of the carotic arteries(CIMT)measured by ultrasound. A total of 900 patients with T2DM and HbA1c above 7.5% will be included.
ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis Trial) EU
AngioplastyTransluminal2 moreTo assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional procedures.
YUKON Choice Versus TAXUS Liberté in Diabetes Mellitus
Coronary ArteriosclerosisRevascularisation procedures such as percutaneous coronary intervention are associated with overall worse outcomes in patients with diabetes mellitus. Implantation of coronary stents is associated with higher restenosis rates compared to non-diabetic individuals. There is only limited data available on the efficacy and safety of the novel Yukon Choice drug-eluting stent system specifically in patients with diabetes mellitus. The trial will determine the efficacy and safety of the novel Yukon Choice stent system compared to the well established Taxus Liberté stent system. The primary endpoint will be "in-stent late lumen loss" at 9 months as determined by invasive angiography.
Inflammation and Coronary Artery Disease: Role of AT1-Receptor Antagonism
HypertensionCoronary ArteriosclerosisEffects of AT1 receptor antagonist telmisartan on the primary endpoint inflammatory parameters in patients with coronary artery disease (CAD). Secondary endpoints are alterations in clinical course and blood pressure
Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent
Coronary ArteriosclerosisThe purpose of this study is to determine whether percutaneous coronary angioplasty with Taxus drug eluting stent is safe and effective in the treatment of unprotected left main coronary artery disease associated to other coronary lesions or not.
Safety and Efficacy of the Combo Bio-engineered Sirolimus-eluting Stent Versus the Nano Polymer-free...
Coronary ArteriosclerosisTo evaluate the safety, efficacy and deliverability of the Combo bio-engineered sirolimus-eluting stent versus the Nano polymer-free sirolimus- eluting stents in the treatment of patients with de novo stenotic lesions of native coronary artery.